Guidance for Industry

An Acceptable 

Circular of Information for the Use of 

Human Blood and Blood Components 

FINAL GUIDANCE

Additional copies of this guidance and the “Circular of Information for the Use of Human Blood and 

Blood Components” are available from the Office of Communication, Training and Manufacturers 

Assistance (HFM-40), 1401 Rockville Pike, Rockville, MD 20852-1448 or by calling 1-800-835-

4709 or 301-827-1800, or from the Internet at http://www.fda.gov/cber/guidelines.htm.

For questions on the content of the document, contact the Office of Blood Research and Review at 

301-827-6178.

U.S. Department of Health and Human Services

Food and Drug Administration

Center for Biologics Evaluation and Research

December 2003
Contains Nonbinding Recommendations

i

TABLE OF CONTENTS

I. INTRODUCTION ............................................................................................................1

II. BACKGROUND...............................................................................................................1

III. FDA REVIEW AND CONCLUSION .............................................................................2

IV. SUPPLEMENTARY INFORMATION ..........................................................................2

V. THE CIRCULAR..............................................................................................................2
Contains Nonbinding Recommendations

1

Guidance for Industry

An Acceptable Circular of Information for the Use of 

Human Blood and Blood Components

This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this 

topic. It does not create or confer any rights for or on any person and does not operate to bind 

FDA or the public. You can use an alternative approach if the approach satisfies the 

requirements of the applicable statutes and regulations. If you want to discuss an alternative 

approach, contact the appropriate FDA staff. If you cannot identify the appropriate FDA staff, 

call the appropriate number listed on the title page of this guidance.

I. INTRODUCTION

We, the Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER) 

are recognizing as acceptable for use by you, manufacturers of blood and blood components intended 

for transfusion subject to United States statutes and regulations, the instruction circular entitled “Circular 

of Information for the Use of Human Blood and Blood Components” (Circular) dated July 2002. The

July 2002 Circular provides specific labeling directions for the administration and use of blood and 

blood components intended for transfusion. We believe that the Circular will assist you in complying 

with labeling requirements under 21 CFR 606.122 (§ 606.122). The requirements under § 606.122 

specify that an instruction circular must be available for distribution with blood and blood components 

intended for transfusion. Section 606.122 further specifies the information that is required in the 

instruction circular. This guidance finalizes the draft guidance of the same title dated October 2002.

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. 

Instead, guidances describe the FDA’s current thinking on a topic and should be viewed only as 

recommendations, unless specific regulatory or statutory requirements are cited. The use of the word 

should in FDA’s guidances mean that something is suggested or recommended, but not required.

II. BACKGROUND

The Circular is prepared jointly by the American Association of Blood Banks (AABB), America’s 

Blood Centers (ABC), and the American National Red Cross (ARC). The Circular is periodically 

updated to address changes in regulations, technology, testing, and product indications. AABB 

submitted to us a revised draft version of the Circular dated July 2002. This version updates the 

previous version dated August 2000. We reviewed the August 2000 submission and sent comments to 

AABB. AABB incorporated our comments and submitted the final version to us in July 2002.
Contains Nonbinding Recommendations

2

III. FDA REVIEW AND CONCLUSION

We have reviewed the final (July 2002) version of the Circular and find it acceptable for use in the 

labeling of blood and blood components intended for transfusion under § 606.122. Manufacturers that 

have implemented licensed nucleic acid tests (NAT) may use the July 2002 Circular. A copy of the 

Circular is found in section V. below. Those manufacturers that have not yet implemented NAT may 

continue to use the August 2000 version of the Circular. Any subsequent modifications to the version of 

the Circular dated July 2002 by AABB, ABC, and ARC are not covered by this guidance. 

IV. SUPPLEMENTARY INFORMATION

Persons may obtain the Circular dated July 2002 from:

American Association of Blood Banks

8101 Glenbrook Road

Bethesda, MD 20814-2749

Persons with access to the Internet may obtain the Circular at http://www.aabb.org/.

The guidance and Circular may be obtained by mail by calling the CBER Voice Information System at 

1-800-835-4709 or 301-827-1800. Persons with access to the Internet may also obtain the guidance 

and Circular at http://www.fda.gov/cber/guidelines.htm.

V. THE CIRCULAR

Below is a copy of the “Circular of Information for the Use of Human Blood and Blood Components”

dated July 2002 that we, through this guidance document, recognize as acceptable:
CIRCULAR OF

INFORMATION

FOR THE USE OF HUMAN BLOOD

AND BLOOD COMPONENTS

This circular was prepared jointly by the American

Association of Blood Banks, America’s Blood Centers and

the American Red Cross, and is recognized as acceptable

by the Food and Drug Administration.

Federal law prohibits dispensing the blood and blood components described in this circular without a prescription.
Table of Contents

Notice to All Users . . . . . . . . . . . . . . . . . . . . . 1

General Information . . . . . . . . . . . . . . . . . . . . 1

Donors . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Testing of Donor Blood . . . . . . . . . . . . . . . . . 2

Blood and Component Labeling . . . . . . . . . . . . . 3

Instructions for Whole Blood and All Components . . . 3

Side Effects and Hazards . . . . . . . . . . . . . . . . . 5

Immunologic Complications, Immediate . . . . . . . . 5

Immunologic Complications, Delayed . . . . . . . . . 6

Nonimmunologic Complications . . . . . . . . . . . . 7

Fatal Transfusion Reactions . . . . . . . . . . . . . . . 9

Components Containing Red Blood Cells . . . . . . . . 10

Whole Blood and Other Red-CellContaining Components . . . . . . . . . . . . . . . 10

Components Available . . . . . . . . . . . . . . . . . 14

Plasma Components . . . . . . . . . . . . . . . . . . . 23

Plasma Components Containing

Functional Amounts of Labile Coagulation

Factors (Factors V and VIII). . . . . . . . . . . . . 23

Plasma Components Containing Reduced

Amounts of Labile Coagulation Factors . . . . . . 24

Plasma, Cryoprecipitate Reduced (PLASMA

CRYOPRECIPITATE REDUCED) . . . . . . . . . . . . 25

Cryoprecipitate Components. . . . . . . . . . . . . . . 26

Cryoprecipitated AHF; Cryoprecipitated AHF,

Pooled (CRYOPRECIPITATED AHF, POOLED

CRYOPRECIPITATED AHF) . . . . . . . . . . . . . . 26

Platelet Components . . . . . . . . . . . . . . . . . . . 28

Platelets (PLATELETS) . . . . . . . . . . . . . . . . . . 28

Components Available . . . . . . . . . . . . . . . . . 31

Granulocyte Components . . . . . . . . . . . . . . . . 33

Further Processing . . . . . . . . . . . . . . . . . . . . 34

Leukocyte Reduction

Examples of Leukocyte-Reduced Components:

Red Blood Cells Leukocytes Reduced; (RED

BLOOD CELLS LEUKOCYTES REDUCED)

Platelets Leukocytes Reduced; (PLATELETS

LEUKOCYTES REDUCED)

Platelets Pheresis Leukocytes Reduced (APHERESIS

PLATELETS LEUKOCYTES REDUCED) . . . . . . . . 35
Further Testing to Identify CMV-Seronegative

Blood. . . . . . . . . . . . . . . . . . . . . . . . . 36

Irradiation. . . . . . . . . . . . . . . . . . . . . . . . 36

Washing

Examples of Washed Components:

Red Blood Cells Washed (WASHED RED

BLOOD CELLS)

Platelets Washed (WASHED PLATELETS)

Platelets Pheresis Washed (WASHED APHERESIS

PLATELETS). . . . . . . . . . . . . . . . . . . . . 37

References . . . . . . . . . . . . . . . . . . . . . . . . . 37

Summary of Chart of Blood Components . . . . . . 16-21
Notice to All Users

The Circular of Information for the Use of Human Blood and

Blood Components (hereafter referred to as Circular) is an

extension of container labels, as the space on those labels is

limited.

Blood and blood components are biologic products and,

in the form of cellular products, living human tissue intended

for use in patient treatment. Professional judgment based on

clinical evaluation determines the selection of components,

dosage, rate of administration, and decisions in situations not

covered in this general statement.

WARNING: Because whole blood and blood components

are made from human blood, they may carry a risk of transmitting infectious agents, eg, viruses, and theoretically, the

Creutzfeldt-Jakob disease (CJD) agent and variant

Creutzfeldt-Jakob disease (vCJD) agent. Careful donor selection and available laboratory tests do not eliminate the

hazard. Also, septic and toxic reactions can result from transfusion of bacterially contaminated blood and components.

Such reactions are infrequent, but may be life-threatening. In

addition, blood components may contain certain immunizing

substances other than those indicated on the label. For example, Platelets may contain red cells and white cells as well as

platelets. Therefore, this Circular, as a whole or in part, cannot be considered or interpreted as an expressed or implied

warranty of the safety or fitness of the described blood or

blood components when used for their intended purpose. Attention to the specific indications for blood components is

needed to prevent inappropriate transfusion.

Because of the risks associated with transfusion, physicians should remain familiar with currently recognized alternatives to transfusion. Autologous transfusion techniques

(such as perioperative collection and preoperative donation)

should be considered, when indicated, to reduce the need for

allogeneic transfusion with its attendant risks of disease

transmission and immune reactions.

This Circular is supplied to conform with applicable federal statutes and regulations of the Food and Drug Administration (FDA), US Department of Health and Human Services.

General Information

Donors

Blood and components described in this Circular have been

collected from human donors who have been questioned

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about hepatitis and acquired immunodeficiency syndrome

(AIDS) high-risk behavior and about practices and circumstances that should cause them to refrain from donating; have

satisfactorily completed a health assessment that includes a

questionnaire on past and present illnesses; have satisfied

minimum physiologic criteria; and who may have had the opportunity to confidentially exclude their donation from

transfusion. The provision of truthful and accurate information by a donor during health assessment is essential for the

exclusion of donors whose blood may transmit diseases to recipients.

Testing of Donor Blood

Testing of a sample of donor blood is performed before units

of blood or blood components are distributed for routine

transfusion. The label on the container indicates the donor’s

ABO group and, when appropriate, Rh type. When “Rh Negative” is indicated, the blood has been tested and found negative for the presence of the D antigen including the weak expression of D (weak D).

A sample from each donation intended for allogeneic use

has been tested by FDA-licensed tests and found negative for

antibodies to human immunodeficiency virus (anti-HIV1/2), hepatitis C virus (anti-HCV), human T-cell lymphotropic virus (anti-HTLV-I/II), and hepatitis B core antigen

(anti-HBc), and nonreactive for hepatitis B surface antigen

(HBsAg). Licensed nucleic acid tests (NAT) for HCV RNA

and HIV-1 RNA have been performed and found to be nonreactive. A serologic test for syphilis has been performed and

found to be nonreactive. Alanine aminotransferase (ALT)

testing is no longer required to qualify blood for transfusion.

For units labeled for autologous use only, at a minimum

the first donation from the donor-patient in each 30-day period is tested for evidence of infection as listed above. Subsequent units that are not tested will be labeled as “DONOR

TESTED WITHIN THE LAST 30 DAYS.” If an establishment allows any autologous donation to be used for allogeneic transfusion, or ships autologous donations to any establishment that does, the collecting establishment must test

each donation for evidence of infection as listed above. This

includes units labeled for autologous use only. Infectious

disease testing for autologous units may be omitted for

autologous units drawn, stored, and infused at the same facility. Autologous units for which testing has not been performed are labeled “DONOR UNTESTED.” Autologous

units with positive tests may be used for transfusion to the

donor-patient with appropriate physician authorization. A

biohazard label will be applied to autologous units that are

tested for evidence of infection as listed above and determined to be positive.

Tests for unexpected antibodies against red cell antigens

have been performed on samples from all donors. The results

of these tests are negative or have been determined to be clin2
ically insignificant unless otherwise indicated on the label.

Other tests may have been performed on donor blood as indicated by information that has been provided by the blood

bank or transfusion service on an additional label or tie tag,

or in a supplement to this Circular.

Blood and Component Labeling

All blood components identified in this Circular have the

ISBT 128 product name listed in parenthesis after the currently recognized component name. ISBT 128 is a new system of identifying, naming, and barcoding blood components. Labels will contain the following information:

1. The proper name, whole blood or component, including an indication of any qualification or modification.

2. The method by which the component was prepared, either by whole blood or apheresis collection.

3. The temperature range in which the component is to be

stored.

4. The preservatives and anticoagulant used in the preparation of the blood or components, when appropriate.

5. The standard contents or volume is assumed unless

otherwise indicated on the label or in Circular supplements.

6. The number of units in pooled components and any

sedimenting agent used during cytapheresis

7. The name, address, registration number, and US license number (if applicable) of the collection and processing location.

8. The expiration date (and time if applicable), which

varies with the method of preparation (open or closed

system) and the preservatives and anticoagulant used.

When the expiration time is not indicated, the product

expires at midnight.

9. The donation (unit or pool) identification number.

10. The donor category (paid or volunteer, and autologous

if applicable).

11. ABO group and Rh type, if applicable.

12. Special handling information, as required.

13. Statements regarding recipient identification, this Circular, infectious diseases risk, and prescription requirement.

Instructions for Whole Blood and All

Components

The following general instructions pertain to Whole Blood

and all the components described in this Circular:

1. All blood and blood components must be maintained

in a controlled environment and stored under appropriate conditions as described in the AABB Standards for

Blood Banks and Transfusion Services.

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2. The intended recipient and the blood container must be

properly identified before the transfusion is started.

3. Sterility must be maintained.

4. All blood components must be transfused through a filter designed to remove clots and aggregates (generally

a standard 170- to 260-micron filter).

5. Blood and components should be mixed thoroughly

before use.

6. No medications or solutions may be routinely added to

or infused through the same tubing with blood or components with the exception of 0.9% Sodium Chloride,

Injection (USP), unless a) they have been approved for

this use by the FDA or b) there is documentation available to show that the addition is safe and does not adversely affect the blood or component.

7. Lactated Ringer’s, Injection (USP) or other solutions

containing calcium should never be added to or infused through the same tubing with blood or components containing citrate.

8. Blood and components must be inspected immediately

prior to issue. If upon visual inspection the container is

not intact or the appearance is abnormal (presence of

excessive hemolysis, a significant color change in the

blood bag as compared with the tubing segments, floccular material, cloudy appearance or other problems,

etc), it must not be used for transfusion.

9. Blood components have been prepared by techniques

that aid in preserving sterility up to the time of expiration. If the container is entered in a manner that violates the integrity of the system, the component expires

4 hours after entry if maintained at room temperature

(20-24 C), or 24 hours after entry if refrigerated (1-6

C).

10. Blood components may be warmed if clinically indicated for situations such as exchange or massive transfusions, or for patients with cold-reactive antibodies.

Warming must be accomplished using an FDA-cleared

warming device so as not to cause hemolysis.

11. Some life-threatening reactions occur after the infusion

of only a small volume of blood. Therefore, unless otherwise indicated by the patient’s clinical condition, the

rate of infusion should initially be slow. Periodic observation and recording of vital signs should occur during

and after the transfusion to identify suspected adverse

reactions. If a transfusion reaction occurs, the transfusion must be discontinued immediately and appropriate

therapy initiated. The infusion should not be restarted

unless approved by transfusion service protocol. Specific instructions concerning possible adverse reactions

shall be provided to the patient or a responsible caregiver when direct medical observation or monitoring of

the patient will not be available after transfusion.

12. Transfusion should be completed within 4 hours and

prior to component expiration.

4
13. All adverse events related to transfusion, including

possible bacterial contamination of a blood component or suspected disease transmission, must be reported to the transfusion service according to its local

protocol.

14. Blood banks and transfusion services are referred to

the AABB Standards for Blood Banks and Transfusion

Services for additional information and policies, especially in the areas of recipient sample identification,

compatibility testing, issue and transfusion of blood

and blood components, investigation of transfusion reactions, and proper record-keeping practices.

15. Transfusionists are referred to the AABB Technical

Manual for applicable chapters on adult and pediatric

transfusion.

16. Transfusionists are directed to the specific product

manufacturer’s package insert for instructions pertaining to use of transfusion devices, eg, filters, blood administration sets, and blood warmers.

Side Effects and Hazards

The following side effects and hazards pertain to transfusion

of Whole Blood or any component prepared from blood collected from individual donors.

Immunologic Complications, Immediate

1. Hemolytic transfusion reaction, the destruction of

transfused red cells, is discussed in detail in the section

on red-cell-containing components.

2. Immune-mediated platelet destruction, one of the

causes of refractoriness to platelet transfusion, is the

result of alloantibodies in the recipient to HLA or

platelet-specific antigens on transfused platelets. This

is described in more detail in the section on Platelets.

3. Febrile nonhemolytic reaction is typically manifested

by a temperature elevation of ≥ 1 C or 2 F occurring

during or shortly after a transfusion and in the absence

of any other pyrexic stimulus. This may reflect the action of antibodies against white cells or the action of

cytokines, either present in the transfused component

or generated by the recipient in response to transfused

elements. Febrile reactions may accompany about 1%

of transfusions; and they occur more frequently in patients previously alloimmunized by transfusion or pregnancy. No routinely available pre- or posttransfusion

tests are helpful in predicting or preventing these reactions. Antipyretics usually provide effective symp5
tomatic relief. Patients who experience repeated, severe febrile reactions may benefit from receiving

leukocyte-reduced components. If these reactions are

due to cytokines in the component, prestorage leukocyte reduction may be beneficial.

4. Allergic reactions usually occur as urticaria, but may

also include wheezing or angioedematous reactions.

No laboratory procedures are available to predict or

prevent these reactions, which usually respond to antihistamines or, in severe cases, corticosteroids or epinephrine.

5. Anaphylactoid reactions, characterized by autonomic

dysregulation, severe dyspnea, pulmonary and/or laryngeal edema, and bronchospasm and/or laryngospasm, are a rare but dangerous complication requiring

immediate treatment with corticosteroids and epinephrine. The majority of these reactions have been reported in IgA-deficient patients who have IgA antibodies of the IgE class. Such patients may not have

been previously transfused and may develop symptoms after infusion of very small amounts of IgAcontaining plasma, in any blood component.

6. Transfusion-related acute lung injury (TRALI) occurs

when acutely increased permeability of the pulmonary

microcirculation causes massive leakage of fluids and

protein into the alveolar spaces and interstitium, usually within 6 hours of transfusion. In many cases, the

occurrence of TRALI is associated with the presence

of granulocyte antibodies in the donor or recipient.

The specific mechanism of action is not clear. Treatment consists of aggressive respiratory support.

Immunologic Complications, Delayed

1. Delayed hemolytic reaction is described in detail in the

section on red-cell-containing components.

2. Alloimmunization to antigens of red cells, white cells,

platelets, or plasma proteins may occur unpredictably

after transfusion. Primary immunization does not become apparent until days or weeks after the immunizing event, and does not usually cause symptoms or

physiologic changes. If components that express the

relevant antigen are subsequently transfused, there

may be accelerated removal of cellular elements from

the circulation and/or systemic symptoms. Clinically

significant antibodies to red cell antigens will ordinarily be detected by pretransfusion testing. Alloimmunization to antigens of white cells, platelets, or

plasma proteins can only be detected by specialized

testing.

3. Posttransfusion purpura (PTP) is a rare syndrome

characterized by the development of dramatic, sudden,

and self-limiting thrombocytopenia, typically 7-10

6
days after a blood transfusion, in a patient with a history of sensitization by either pregnancy or transfusion. While the immune specificity may be to a

platelet-specific antigen the patient lacks, autologous

and allogeneic platelets are destroyed. In a bleeding

patient, high dose Immune Globulin Intravenous

(IGIV) may promptly correct the thrombocytopenia.

4. Graft-vs-host disease (GVHD) is a rare but extremely

dangerous condition that occurs when viable T lymphocytes in the transfused component engraft in the recipient and react against tissue antigens in the recipient. GVHD can occur if the host does not recognize as

foreign and reject the transfused cells, and can follow

transfusion of any component that contains even very

small numbers of viable T lymphocytes. Severely

immunocompromised recipients are at greatest risk

(eg, fetuses receiving intrauterine transfusions, recipients of transplanted marrow or peripheral blood progenitor cells, and selected patients with severe immunodeficiency conditions), but GVHD has been

reported in immunologically normal recipients heterozygous for a tissue antigen haplotype for which the donor is homozygous. This is most likely to occur when

the transfused component is from a blood relative or

has been selected for HLA compatibility. GVHD remains a risk with leukocyte-reduced components because they contain sufficient residual T lymphocytes.

Irradiation of the component renders T lymphocytes

incapable of proliferation and is presently the only approved means to prevent GVHD.

Nonimmunologic Complications

1. Transmission of infectious disease may occur because

this product is made from human blood. This may be

due to known or unknown agents, such as viruses. This

may occur despite careful selection of donors and testing of blood. Donor selection criteria are designed to

screen out potential donors with increased risk of infection with HIV, HTLV, hepatitis, and syphilis, as

well as other agents (see section on Testing of Donor

Blood). These procedures do not totally eliminate the

risk of transmitting these agents.

Cytomegalovirus (CMV) may, unpredictably, be

present in white-cell-containing components from donors previously infected with this virus, which can persist lifelong despite the presence of serum antibodies.

Up to 70% of donors may be anti-CMV positive.

Transmission of CMV by transfusion may be of concern in low-birthweight (≤1200 grams) premature infants born to CMV seronegative mothers and in certain

other categories of immunocompromised individuals,

7
if they are CMV seronegative. For at-risk recipients,

the risk of CMV transmission by cellular components

can be reduced by transfusing CMV seronegative or

leukocyte-reduced components.

For other infectious agents, there are no routinely

available tests to predict or prevent disease transmission. All potential blood donors are subjected to stringent screening procedures intended to reduce to a minimum the risk that they will transmit infectious agents.

These organisms include Babesia spp., Bartonella

spp., Borrelia spp., Brucella spp., the agent of Colorado tick fever, Leishmania spp., Parvovirus spp.,

plasmodia, rickettsia, Toxoplasma spp., and certain

trypanosomes.

2. Bacterial contamination occurs rarely but can cause

acute, severe, sometimes life-threatening effects. Onset of high fever (≥2 C or ≥3.5 F rise in temperature),

severe chills, hypotension, or circulatory collapse during or immediately after transfusion should suggest

the possibility of bacterial contamination and/or

endotoxin reaction. Platelet components stored at

room temperature, previously frozen components

thawed by immersion in a waterbath, and red cell components stored for several weeks at 1-6 C have been

implicated. Both gram-positive and gram-negative organisms have been identified as causing septic reactions. Organisms capable of multiplying at low temperatures and those using citrate as a nutrient are most

often associated with red cell contamination. A variety

of pathogens, as well as skin contaminants, have been

found in platelet concentrates. Endotoxemia in recipients has resulted from multiplication of Yersinia

enterocolitica in stored red-cell-containing components.

Prompt recognition of a possible septic reaction is

essential, with immediate discontinuation of the transfusion and aggressive therapy with broad-spectrum

antimicrobials and vasopressor agents, if necessary.

In addition to prompt sampling of the patient’s blood

for cultures at several different temperatures, investigation should include examination of material from

the blood container by Gram’s stain, and cultures of

specimens from the container and the administration

set.

3. Circulatory overload, leading to pulmonary edema,

can occur after transfusion of excessive volumes or at

excessively rapid rates. This is a particular risk in the

elderly and in patients with chronic severe anemia in

whom low red cell mass is associated with high plasma

volume. Small transfusion volumes can precipitate

symptoms in at-risk patients who already have a positive fluid balance.

Pulmonary edema should be promptly and aggressively treated, and infusion of colloid preparations, in8
cluding plasma components and the suspending

plasma in cellular components, reduced to a minimum.

4. Hypothermia carries a risk of cardiac arrhythmia or

cardiac arrest. Rapid infusion of large volumes of cold

blood can depress body temperature, and the danger is

compounded in patients experiencing shock or surgical or anesthetic manipulations that disrupt temperature regulation. A blood warming device should be

considered if rapid infusion of blood is needed.

Warming must be accomplished using an FDA-cleared

warming device so as not to cause hemolysis.

5. Metabolic complications may accompany largevolume transfusions, especially in patients with liver

or kidney disease.

a. Citrate “toxicity” reflects a depression of ionized

calcium due to the presence in the circulation of

large quantities of citrate anticoagulant. Because

citrate is promptly metabolized by the liver, this

complication is rare. Patients with severe liver disease or those with circulatory collapse that prevents adequate hepatic blood flow, may have physiologically significant hypocalcemia after rapid,

large-volume transfusion. Citrated blood administered rapidly through central intravenous access

may reach the heart so rapidly that ventricular

arrhythmias occur. Standard measurement of serum calcium does not distinguish ionized from

complexed calcium. Ionized calcium testing or

EKG monitoring is more helpful in detecting physiologically significant alteration in calcium levels.

b. Other metabolic derangements can accompany

rapid or large-volume transfusions, especially in

patients with pre-existing circulatory or metabolic

problems. These include acidosis or alkalosis (deriving from changing concentrations of citric acid

and its subsequent conversion to pyruvate and bicarbonate) and hyper- or hypokalemia.

Fatal Transfusion Reactions

When a fatality occurs as a result of a complication of blood

or component transfusions, the Director, Office of Compliance and Biologics Quality, Center for Biologics Evaluation

and Research (CBER), should be notified within one FDA

business day (telephone: 301-827-6220; e-mail:

fatalities2@cber.fda.gov). Within 7 days after the fatality, a

written report must be submitted to the Director, Office of

Compliance and Biologics Quality, HFM-600, CBER, FDA,

1401 Rockville Pike, Rockville, MD 20852-1448. A copy of

the report should be sent to the collecting facility, if appropriate. Updated information about CBER reporting requirements may be found at www.fda.gov/cber/transfusion.htm.

9
Components Containing Red Blood Cells

Whole Blood and Other Red-Cell-Containing

Components

Description

Red cells contain hemoglobin and serve as the primary mechanism for transport of oxygen to tissues. Whole Blood contains the red cells and plasma constituents of circulating

blood; the primary red-cell-containing transfusion component is Red Blood Cells, prepared by centrifugation or sedimentation of Whole Blood to remove many of the platelets

and white cells of circulating blood and much of the plasma.

Red cell components can be prepared by Whole Blood collection or by apheresis.

Depending upon the collection system used, a single

whole blood donation typically contains either 450 mL

(±10%) or 500 mL (±10%) of blood with a minimum

hematocrit of 38%, withdrawn in a sterile container that contains an anticoagulant solution licensed for this use. Occasionally, Whole Blood units of other volumes are collected

and those volumes are stated on the label.

Whole Blood can be stored for an interval (“shelf life”)

determined by the properties of the anticoagulantpreservative solution. Whole Blood units are prepared in a

sterile manner in the empty container at a ratio of 14 mL per

100 mL whole blood collected. Actual collection volume

may be ± 10%.

After plasma is removed, the resulting component is Red

Blood Cells, a component that has a hematocrit of 65-80%

and a usual volume between 225 and 350 mL. Additive solutions (AS) may be mixed with the red cells remaining after removal of nearly all of the plasma. The typical hematocrit of

AS Red Blood Cells is 55-65% and their volume is approximately 300-400 mL.

Red Blood Cells can also be collected by apheresis. This

component must be collected in approved anticoagulants.

The red cell volume collected and the anticoagulant used are

noted on the label.

Descriptions of specific red-cell-containing components

are given at the end of this section.

Actions

Whole Blood and all Red Blood Cell components increase

the recipient’s oxygen-carrying capacity by increasing the

mass of circulating red cells. Processing and/or storage deplete the component of virtually all potential therapeutic

benefit attributable to the functions of white cells and platelets; cellular elements remain in these blood components and

may cause adverse immunologic or physiologic conse10
11

Summary Chart of Anticoagulants

Anticoagulant/Preservative

TrisodiumCitrate Citric Acid

MonobasicSodiumPhosphate Dextrose Adenine Shelf Life

Anticoagulant Citrate

Dextrose -A(ACD-A)

22.0 g/L 8.0 g/L 0 24.5 g/L 0 21 days

Citrate Phosphate

Dextrose (CPD)

26.3 g/L 3.27 g/L 2.22 g/L 25.5 g/L 0 21 days

Citrate Phosphate

Dextrose (CP2D)

26.3 g/L 3.27 g/L 2.22 g/L 51.1 g/L 0 21 days

Citrate Phosphate

Dextrose Adenine(CPDA-1)

26.3 g/L 3.27 g/L 2.22 g/L 31.9 g/L 0.275 g/L 35 days

Note: Anticoagulant Citrate Dextrose is used as a preservative for apheresis components as recommended by the manufacturer.
quences. Residual plasma in the component provides the recipient with volume expansion and nonlabile plasma proteins to the extent that residual plasma is present in the

preparation. Depending on the method of production, Red

Blood Cells may contain approximately 20 mL to 150 mL of

residual plasma.

Indications

Red-cell-containing components are indicated for treatment

of symptomatic deficit of oxygen-carrying capacity. They

are also indicated for exchange transfusion.

Contraindications

Red-cell-containing components should not be used to treat

anemias that can be corrected with specific medications such

as iron, vitamin B12, folic acid, or erythropoietin.

Whole Blood and Red Blood Cells should not be used as

volume expanders or to increase oncotic pressure of circulating blood.

Dosage and Administration

Each unit of Whole Blood or Red Blood Cells contains

enough hemoglobin to raise the hemoglobin concentration in

an average-sized adult by approximately 1 g/dL (raise

hematocrit by 3 percentage points). Smaller aliquots can be

made available for use with neonatal or pediatric patients, or

adults with special transfusion needs.

The ABO group of all red-cell-containing components

must be compatible with ABO antibodies in the recipient’s

plasma. Whole Blood must be ABO-identical with the recipient; Red Blood Cells, which contain a reduced volume of antibody-containing plasma, need not be ABO-identical.

Except in cases when any delay in transfusion will be

life-threatening, serologic compatibility between recipient

and donor must be established before any red-cellcontaining component is transfused. This may be accomplished by performing ABO/Rh type, antibody screen, and

crossmatching by serologic technique or use of electronic selection (“computer crossmatch”).

The initial portion of each transfusion should be infused

slowly, except in urgent situations, and with sufficient observation to detect onset of acute immunologic or infectious

complications. Thereafter, the rate of infusion can be more

rapid, as tolerated by the patient’s circulatory system. It is

undesirable for red-cell-containing components to remain at

room temperature longer than 4 hours. If the anticipated infusion rate must be so slow that the entire unit cannot be infused

within 4 hours, it may be appropriate to order smaller

aliquots for transfusion.

12
Side Effects and Hazards

Hazards that pertain to all transfusion components are described in the earlier section entitled Side Effects and Hazards. Listed below are hazards that apply specifically to components that contain red cells.

1. Hemolytic transfusion reaction is the immunologic

destruction of transfused red cells, nearly always due

to incompatibility of antigen on the transfused cells

with antibody in the recipient’s circulation. (See 5 for

discussion of nonimmunologic hemolysis.) The most

common cause of severe, acute hemolytic reactions is

transfusion of ABO-incompatible blood, resulting

from identification errors occurring at some point(s) in

the transfusion process. Serologic incompatibility undetected during pretransfusion testing is a much less

common cause of acute hemolysis. If a hemolytic reaction is suspected, the transfusion must be stopped and

the transfusion service laboratory notified. Information identifying the patient, the transfusion component, and associated forms and labels should be reviewed immediately to detect possible errors. A

postreaction blood sample, preferably drawn from a

site other than the transfusion access, should be sent to

the laboratory along with the implicated unit of blood

and administration set.

Acute hemolytic reactions characteristically begin

with an increase in temperature and pulse rate; symptoms may include chills, dyspnea, chest or back pain,

abnormal bleeding, or shock. Instability of blood pressure is frequent, the direction and magnitude of change

depending upon the phase of the antigen-antibody

event and the magnitude of compensatory mechanisms. In anesthetized patients, hypotension and evidence of disseminated intravascular coagulopathy

(DIC) may be the first sign of incompatibility. Laboratory findings can include hemoglobinemia and/or

hemoglobinuria, followed by elevation of serum bilirubin; in less catastrophic acute hemolytic reactions, a

positive direct antiglobulin test (DAT) is commonly

found. Treatment includes measures to maintain or

correct arterial blood pressure; correct coagulopathy,

if present; and promote and maintain urine flow.

Rarely, acute hemolytic reactions may not be overtly

apparent.

Delayed hemolytic reactions occur in previously

red-cell-alloimmunized patients in whom antigens on

transfused red cells provoke anamnestic production of

antibody that reaches a significant circulating level

while the transfused cells are still present in the circulation; the usual time frame is 2 to 14 days after transfusion. Signs may include unexplained fever, development of a positive DAT, and unexplained decrease in

hemoglobin/hematocrit. Hemoglobinemia and

13
hemoglobinuria are uncommon, but elevation of lactic

dehydrogenase (LDH) or bilirubin may be noted. Most

delayed hemolytic reactions have a benign course and

require no treatment.

2. Antigens on transfused red cells may cause red cell

alloimmunization of the recipient, who may experience red cell antibody-mediated reactions to subsequent transfusions. There is no practical way to predict

or prevent alloimmunization in any specific transfusion recipient. Clinically significant antibodies to red

cell antigens will usually be detected in pretransfusion

antibody screening tests.

3. Circulatory overload, resulting in pulmonary edema,

can accompany transfusion of any component at a rate

more rapid than the recipient’s cardiac output can accommodate. Whole Blood creates more of a risk than

Red Blood Cells because the transfused plasma adds

volume without increasing oxygen-carrying capacity.

Patients with chronic anemia have increased blood

volumes and are at increased risk for circulatory overload.

4. Iron overload is a long-term complication of repeated

red cell transfusions. Each transfusion contributes approximately 250 mg of iron. Patients requiring multiple transfusions for aplastic anemia, thalassemias, or

hemoglobinopathies are at far greater risk than patients transfused for hemorrhagic indications, because

blood loss is an effective means of iron excretion. Patients with predictably chronic transfusion requirements should be considered for treatment with ironchelating agents.

5. Nonimmunologic hemolysis occurs rarely, but can result from: a) introduction of hypotonic fluids into the

circulation; b) effects of drugs co-administered with

transfusion; c) effects of bacterial toxins; d) thermal

injury to transfusion components, by either freezing or

overheating; e) metabolic damage to cells, as from

hemoglobinopathies or enzyme deficiencies; or f) if

sufficient physical or osmotic stresses develop, for example, if red blood cells are exposed to excessive heat

by non-FDA approved warming methods, mixed with

hypotonic solutions or transfused under high pressure

through small gauge/defective needles.

Components Available

1. Red Blood Cells (RED BLOOD CELLS) are prepared from

blood collected into any of the anticoagulantpreservative solutions approved by the FDA, and separated from the plasma by centrifugation or sedimentation. Separation may be done at any time during the allowable storage interval (“shelf life”). Red Blood

14
Cells may contain from 160-275 mL of red cells (50-80

g of hemoglobin) suspended in varying quantities of

residual plasma. Units of Whole Blood that are less

than 405 mL (450 mL - 10%) are sometimes collected

and prepared into Red Blood Cells, Low Volume (RED

BLOOD CELLS LOW VOLUME). These preparations may require adjustment of the anticoagulant solution supplied in standard blood collection containers.

2. Red Blood Cells, Adenine Saline Added (RED BLOOD

CELLS ADENINE SALINE ADDED) are prepared by centrifuging whole blood to remove as much plasma as possible, and replacing the plasma with usually 100-110

mL of an additive solution that contains some combination of dextrose, adenine, sodium chloride, and either monobasic sodium phosphate (AS-3) or mannitol

(AS-1 and AS-5); the hematocrit is usually between 55

and 65%. Red cells in an additive solution have lower

viscosity than Red Blood Cells, and flow through administration systems in a manner more comparable to

that of Whole Blood. Red cells stored with an additive

solution have an extended shelf life.

3. Red Blood Cells Leukocytes Reduced (RED BLOOD

CELLS LEUKOCYTES REDUCED) are described in the later

section on Further Processing.

4. Red Blood Cells Frozen (FROZEN RED BLOOD CELLS)

and Red Blood Cells Rejuvenated Frozen (FROZEN

REJUVENATED RED BLOOD CELLS) are prepared by adding

glycerol to red cells as a cryoprotective agent before

freezing. The glycerol must be removed from the

thawed component before it is infused. Frozen red

cells may be stored for up to 10 years, and for longer intervals if there is particular need for specific units.

Frozen storage is especially suitable for red cells with

unusual antigenic phenotypes and for autologous donations when liquid-preserved blood cannot fulfill demands.

5. Red Blood Cells Deglycerolized (DEGLYCEROLIZED

RED BLOOD CELLS) is the form in which cryopreserved

red cells (Red Blood Cells Frozen) are available for infusion. Glycerol is added to red cells as a cryoprotective agent before freezing, and must be removed

from the thawed component before it is infused.

Red Blood Cells Deglycerolized contain 80% or

more of the red cells present in the original unit of

blood, and have approximately the same expected

posttransfusion survival as Red Blood Cells. Glycerol

is removed by washing the cells with successively

lower concentrations of Sodium Chloride Injection

(USP); the final suspension is in 0.9% Sodium Chloride, Injection (USP), with or without small amounts

of dextrose. Small amounts of residual free hemoglobin may cause the supernatant fluid to be pinktinged.

15
16Summary Chart of Blood Components

Category

Major Indications Action/Recipient Benefit Not Indicated for Special Precautions Hazards* Rate of Infusion

Whole Blood Symptomatic anemia

with large volumedeficit

Increases oxygen-carrying

capacity

Increases blood

volume

Condition responsive

to specific component

Volume expansionTreatment of

coagulopathy

Must be ABO identical Infectious diseases Hemolytic, septic/toxic, allergic,

febrile reactions

Circulatory overload

GVHD

For massive loss, as

fast as patient cantolerate

Must be infused

within 4 hours

Whole Blood

Irradiated

See Whole Blood,

Risk for GVHD

See Whole BloodDonor lymphocytes

are inactivated

Risk of GVHD reduced

See Whole Blood See Whole Blood See Whole Blood See Whole Blood

Red Blood Cells;

Red Blood Cells,(Adenine-SalineAdded); RedBlood Cells, LowVolume; RedBlood CellsPheresis

Symptomatic anemia Increases oxygen-carrying

capacity

Pharmacologically

treatable anemia

Coagulation deficiencyVolume expansion

Must be

ABO-compatible

Infectious diseasesHemolytic, septic/toxic, allergic,

febrile reactions

GVHD

As fast as patient can

tolerate but lessthan 4 hours
17

Red Blood Cells

Deglycerolyzed

See Red Blood Cells

IgA deficiencywith anaphylactoidreaction

See Red Blood CellsDeglycerolization removes plasma proteinsRisk of allergic and

febrile reactionsreduced

See Red Blood Cells See Red Blood Cells See Red Blood Cells

Hemolysis due to incomplete

deglycerolizationcan occur

See Red Blood Cells

Red Blood Cells

Irradiated

See Red Blood

Cells Risk forGVHD

See Red Blood

Cells

Donor lymphocytes are inactivatedRisk of GVHD reduced

See Red Blood

Cells

See Red Blood

Cells

See Red Blood

Cells

See Red Blood

Cells

Red Blood Cells

Leukocytes Reduced

See Red Blood Cells

Febrile reactionsdue to leukocyteantibodies

See Red Blood CellsReduction of leukocytes reduces risk

of febrile reactions,HLAalloimmunization,and CMV infection

See Red Blood CellsLeukocyte reduction

should not be usedto prevent GVHD

See Red Blood Cells See Red Blood Cells

If using bedside leukocyte reduction

filter, hypotensivereaction may occur

See Red Blood Cells

(cont’d)
18Summary Chart of Blood Components (continued)

Category

Major Indications Action/Recipient Benefit Not Indicated for Special Precautions Hazards* Rate of Infusion

Red Blood Cells

Washed

See Red Blood CellsIgA deficiency with

anaphylatoid reaction

Recurrent severe allergic reactions to

unwashed red cellproducts

See Red Blood CellsWashing reduces

plasma proteins

Risk of allergic reactions may be reduced

See Red Blood Cells See Red Blood Cells See Red Blood Cells See Red Blood Cells

Fresh Frozen

Plasma (FFP);FFP Donor Retested

Deficiency of labile and stable

plasmacoagulation factors

TTP

Source of deficient

or defectiveplasma proteins

Volume replacementCoagulopathy that

can be more effectively treatedwith specifictherapy

Must be

ABO-compatible

Infectious diseases

Allergic reactionsCirculatory overload

Less than 4 hours

Liquid Plasma;

Plasma; ThawedPlasma; PlasmaFrozen Within 24Hours

Deficiency of stable

coagulation factors

Source of nonlabile

coagulationfactors

See FFPDeficiency of Factors V and VIIIVolume replacement

Must be ABOcompatible See FFP Less than 4 hours
19

Plasma

CryoprecipitateReduced

TTP See FFP

Deficient in Factor I,

VIII,VWF andXIII

Deficient in high

molecular weightVWF multimers ascompared to FFP

See FFPDeficiency of coagulation factors

known to be depleted in this product, FactorsI,VIII,VWF, XIII

Volume replacement

Must be

ABO-compatible

See FFP Less than 4 hours

Cryoprecipitated

AHF;CryoprecipitatedAHF, Pooled

Hemophilia Avon Willebrand’s

disease

Hypofibrinogenemia

Factor XIII deficiency

Provides Factor VIII,

fibrinogen, vWF,Factor XIII

Deficiency of any

plasma proteinother than thoseenriched inCryoprecipitatedAHF

Repeated doses may

be necessary

Infectious diseases

Allergic reactions

Less than 4 hours

Platelets;Platelets Pooled

Bleeding due to

thrombocytopeniaor platelet function abnormality

Prevention of bleeding from marrow

hypoplasia

Improves hemostasis Plasma coagulation

deficits

Some conditions

with rapid plateletdestruction (egITP, TTP) unlesslife threateninghemorrhage

Should not use some

filters (check manufacturer’s instructions)

Infectious diseases

Septic/toxic, allergic, febrile reaction

GVHD

Less than 4 hours

(cont’d)
20Summary Chart of Blood Components (continued)

Category

Major Indications Action/Recipient Benefit Not Indicated for Special Precautions Hazards* Rate of Infusion

Platelets Pheresis See Platelets See Platelets

May be HLA (or

other antigen) selected

See Platelets See Platelets See Platelets See Platelets

Platelets Irradiated;

Platelets Pooled Irradiated;

Platelets Pheresis Irradiated

See PlateletsRisk of GVHD

See PlateletsGamma irradiation

inactivates donorlymphocytes reduced risk ofGVHD

See Platelets See Platelets See Platelets See Platelets

Platelets Leukocytes

Reduced;

Platelets Pheresis

Leuokcytes Reduced

See PlateletsPrevention of febrile

reactions

Prevention of HLA

alloimmunization

See PlateletsReduction of leukocytes reduces risk

of febrile reactions,HLAalloimmunization,and CMV infection

See PlateletsLeukocyte reduction

should not be usedto prevent GVHD

See Platelets See Platelets See Platelets
21

Granulocytes

Pheresis; Granulocytes/PlateletsPheresis

See PlateletsNeutropenia with

infection, unresponsive to appropriate antibiotics

Provides granulocytes with or without platelets Infection responsive to antibiotics, eventual marrow

recovery not expected

Must be ABO compatibleShould not use some

filters (check manufacturer’s instructions)

Infectious diseases

Allergic reactionsFebrile reactionsGVHD

One unit over 2-4

hours

Closely observe for

reactions

Granulocytes

Pheresis Irradiated;

Granulocytes Platelets Irradiated

See GranulocytesSee Platelets

Provides granulocytes with or without plateletsDonor lymphocytes

are inactivated

See GranulocytesSee Platelets

See GranulocytesSee Platelets

See GranulocytesSee Platelets

See GranulocytesSee Platelets

*For all cellular components there is risk the recipient may become alloimmunized.RBC-containing components and thawed plasma should be stored at 1-6 C.Platelets, Granulocytes, and thawed Cryprecipitate should be stored at 20-24 C.
Red Blood Cells Deglycerolized provide the same

physiologic benefits as Red Blood Cells, but their use

is usually restricted to situations in which standard

transfusion components are inappropriate or unavailable. Red Blood Cells Deglycerolized may be useful

for red cell transfusions to patients with clinically significant immune reactivity against IgA or other plasma

constituents, because the extensive washing required

to remove glycerol also efficiently removes plasma

constituents.

In addition to the side effects and hazards of red cell

transfusion, Red Blood Cells Deglycerolized carry a

risk of intravascular hemolysis if deglycerolization

has been inadequate.

6. Red Blood Cells Rejuvenated (REJUVENATED RED

BLOOD CELLS) may be prepared from red cells stored in

CPD, CPDA-1, and AS-1 storage solutions up to 3

days after expiration. Addition of an FDA-approved

solution containing inosine, phosphate, and adenine

restores 2,3-diphosphoglycerate (2,3-DPG) and

adenosine triphosphate (ATP) to levels approximating

those of freshly drawn cells. Red Blood Cells Rejuvenated must be washed before infusion to remove the

inosine, which may be toxic. Red Blood Cells Rejuvenated may be washed and transfused within 24 hours or

prepared for frozen storage by standard glycerolization, which also serves to remove inosine.

7. Red Blood Cells Rejuvenated Deglycerolized

(DEGLYCEROLIZED REJUVENATED RED BLOOD CELLS) is the

form in which rejuvenated, cryopreserved red cells

(Red Blood Cells Frozen Rejuvenated) are available

for infusion. For additional information, see sections

on Red Blood Cells Rejuvenated and Red Blood Cells

Deglycerolized above.

8. Whole Blood (WHOLE BLOOD) is rarely used for transfusion because sound resource management usually demands preparation of several components from a single blood donation.

9. Red Blood Cells Pheresis (APHERESIS RED BLOOD

CELLS) are red blood cells collected by apheresis. Aside

from the automated collection method used, the component is comparable to red blood cells collected by

manual phlebotomy in all aspects. The dosage can be

calculated, as for Red Blood Cells, from the red cell

content of the product. Red Blood Cells Pheresis contains on average 60 grams of hemoglobin per unit. For

comparison, a typical unit of Red Blood Cells derived

from a whole blood collection contains 50 to 80 grams

of hemoglobin.

10. Any of the above may be irradiated. See section on

Further Processing.

22
Plasma Components

Plasma Components Containing Functional

Amounts of Labile Coagulation Factors

(Factors V and VIII)

Description

Fresh Frozen Plasma (FFP) is prepared from a whole blood or

apheresis collection and frozen at –18 C or colder within the

time frame required for the anticoagulant or collection process. The anticoagulant solution used is indicated on the label. Component volume varies depending on the method

used to collect and prepare the component. Component volume is indicated on the label. By definition each mL of undiluted plasma contains 1 international unit (IU) of each coagulation factor.

Action

FFP serves as a source of plasma proteins for patients who

are deficient in or have defective plasma proteins.

Indications

FFP is indicated in the following conditions:

1. Management of preoperative or bleeding patients who

require replacement of multiple plasma coagulation

factors (eg, liver disease).

2. Patients with massive transfusion who have clinically

significant coagulation deficiencies.

3. Patients on warfarin who are bleeding or need to undergo an invasive procedure before vitamin K could

reverse the warfarin effect or who need to have anticoagulation therapy after the procedure.

4. For transfusion or plasma exchange in patients with

thrombotic thrombocytopenic purpura (TTP).

5. Management of patients with selected coagulation factor deficiencies, congenital or acquired, for which no

specific coagulation concentrates are available.

6. Management of patients with rare specific plasma protein deficiencies, such as C-1-esterase.

Contraindications

Do not use FFP when coagulopathy can be corrected more effectively with specific therapy, such as vitamin K, Cryoprecipitated AHF, or Factor VIII concentrates.

Do not use FFP when blood volume can be safely and adequately replaced with other volume expanders.

23
Dosage and Administration

Compatibility tests before transfusion are not necessary.

Plasma must be ABO-compatible with the recipient’s red

cells. The volume transfused depends on the clinical situation and patient size, and may be guided by laboratory assays

of coagulation function.

Do not use the frozen component if there is evidence of

container breakage or of thawing during storage. Plasma

must be thawed in a waterbath at 30-37 C or in an FDAcleared device. If a waterbath is used, thaw FFP in a protective plastic overwrap using gentle agitation. Thawed FFP

should be infused immediately or stored at 1-6 C for up to 24

hours. If stored greater than 24 hours, the words “fresh

frozen” must be removed.

Side Effects and Hazards

Hazards that pertain to all transfusion components are described in the earlier section on Side Effects and Hazards.

Antibodies in the plasma may react with the recipient’s

red cells, causing a positive DAT.

Specific Plasma Components

1. Fresh Frozen Plasma (FRESH FROZEN PLASMA) contains

plasma proteins including all coagulation factors.

2. Fresh Frozen Plasma Donor Retested (FRESH FROZEN

PLASMA QUARANTINED RETESTED) is identical in all aspects to FFP except that it is held in quarantine for a

minimum of 112 days from collection, until the donor

from whom it is prepared has been retested and found

negative for all FDA-required and recommended tests.

Such retesting is intended to reduce the risk of virus

transmission from donors who may be in the infectious

window period.

Plasma Components Containing Reduced

Amounts of Labile Coagulation Factors

Description

Other plasma components may be made from whole blood

collected in all approved anticoagulants or by apheresis.

These components contain stable coagulation factors such as

Factor IX and fibrinogen in concentrations similar to that of

FFP, but reduced amounts of Factors V and VIII. The volume

is indicated on the label.

Actions

These components serve as a source of plasma proteins for

patients who have defective or are deficient in plasma proteins, except for Factor V and Factor VIII.

24
Indications

Same as for FFP, except that these components should not be

used to treat coagulation factor deficiencies of Factor V and

Factor VIII.

Contraindications

Same as for FFP. Do not use Plasma, Thawed Plasma, or Liquid Plasma for replacement of coagulation Factors V and

VIII.

Dosage and Administration

Same as for FFP.

Side Effects and Hazards

Same as for FFP.

Specific Plasma Components

1. Thawed Plasma (THAWED PLASMA) is derived from FFP

prepared in a way that ensures sterility (closed system), thawed at 30-37 C, and maintained at 1-6 C for

1-5 days.

2. Plasma Frozen Within 24 Hours After Phlebotomy

(PLASMA FROZEN WITHIN 24 HOURS OF PHLEBOTOMY) must

be separated and placed at –18 C or below within 24

hours from whole blood collection.

3. Plasma; Liquid Plasma (PLASMA; LIQUID PLASMA) is

separated no later than 5 days after the expiration date

of the Whole Blood. Plasma may be stored at –18 C or

below. Liquid Plasma is stored at refrigerator temperature (1-6 C).

Plasma, Cryoprecipitate Reduced (PLASMA

CRYOPRECIPITATE REDUCED)

Description

Plasma, Cryoprecipitate Reduced (PLASMA CRYOPRECIPITATE REDUCED) is prepared from FFP by a process of

rapid freezing, followed by thawing and centrifugation,

which removes the cryoprecipitate and yields plasma that is

deficient in Factor VIII, von Willebrand factor (vWF),

fibrinogen, cryoglobulin, and fibronectin. Proteins such as

albumin, Factors II, V, VII, IX, X, and XI remain in the same

concentration as in FFP. The high-molecular-weight forms

of vWF (multimers) are more thoroughly removed by the

process than smaller multimers. Plasma, Cryoprecipitate Reduced can also be prepared from FFP Donor Retested.

25
Action

This component serves as a source for deficient or defective

plasma proteins except for fibrinogen, Factor VIII, Factor

XIII, and vWF.

Indications

Plasma, Cryoprecipitate Reduced is used for transfusion or

plasma exchange in patients with TTP refractory to FFP. It

may be used to provide clotting factors except Factor I

(fibrinogen), Factor VIII, Factor XIII, and vWF.

Contraindications

This component should not be used as a substitute for FFP.

Dosage and Administration

Same as for FFP.

Side Effects and Hazards

Same as for FFP.

Cryoprecipitate Components

Cryoprecipitated AHF; Cryoprecipitated AHF,

Pooled (CRYOPRECIPITATED AHF, POOLED

CRYOPRECIPITATED AHF)

Description

Cryoprecipitated AHF is prepared by thawing FFP between

1-6 C and recovering the precipitate. The cold-insoluble precipitate is refrozen within 1 hour. Cryoprecipitated AHF contains coagulation Factor VIII, Factor XIII, fibrinogen, vWF,

and fibronectin. Each unit of Cryoprecipitated AHF should

contain ≥ 80 IU Factor VIII units and ≥150 mg of fibrinogen

in approximately 15 mL of plasma.

If the label indicates “Cryoprecipitated AHF, Pooled,”

several units of Cryoprecipitated AHF have been pooled.

The volume of the pool is indicated on the label and, if used,

the volume of 0.9% Sodium Chloride, Injection (USP) added

may be separately listed. To determine the minimum potency

of this component, assume 80 IU of Factor VIII and 150 mg

of fibrinogen for each unit of Cryoprecipitated AHF indicated on the label.

26
Action

Cryoprecipitate serves as a source of Factor VIII, fibrinogen,

vWF, and Factor XIII.

Indications

This component is indicated as second-line therapy for von

Willebrand disease and hemophilia A (Factor VIII deficiency). Coagulation factor preparations are the preferred

components when blood component therapy is needed for

management of von Willebrand disease and Factor VIII deficiency. Cryoprecipitate should be used only if virusinactivated Factor VIII concentrates or recombinant factor preparations are not available for management of patients with hemophilia A or von Willebrand disease. It is

also used in the control of bleeding associated with

fibrinogen deficiency and to treat Factor XIII deficiency. Indications for use as a source of fibronectin are not clear.

Contraindications

Do not use this component unless results of laboratory studies indicate a specific hemostatic defect for which this product is indicated.

Dosage and Administration

Compatibility testing is unnecessary. ABO-compatible material is preferred. Rh type need not be considered when using this component.

The frozen component is thawed in a protective plastic

overwrap in a waterbath at 30-37 C up to 15 minutes (thawing

time may need to be extended if product is pooled before

freezing). This component should not be given if there is evidence of container breakage or of thawing during storage. Do

not refreeze after thawing. Thawed Cryoprecipitated AHF

should be kept at room temperature and transfused as soon as

possible after thawing, or within 6 hours if it is a closed single unit, or within 4 hours if it is an open system or units have

been pooled.

For pooling, the precipitate in each concentrate should be

mixed well with 10-15 mL of diluent to ensure complete removal of all material from the container. The preferred diluent is 0.9% Sodium Chloride, Injection (USP).

For treatment of bleeding in patients with hemophilia A,

rapid infusion of a loading dose expected to produce the desired level of Factor VIII is usually followed by a smaller

maintenance dose every 8-12 hours. To maintain hemostasis

after surgery, a regimen of therapy for 10 days or longer may

be required. If circulating antibodies to Factor VIII are present, the use of larger doses, activated concentrates, porcine-derived concentrates, or other special measures may be

indicated.

27
In the steady state, the half-life of fibrinogen is 3-5 days.

Dosing schedules of cryoprecipitate infusions every 3 days

may be appropriate for patients with congenital hypofibrinogenemia. Thrombosis alters fibrinogen kinetics; therefore,

patients receiving cryoprecipitate as fibrinogen replacement

in conditions associated with increased fibrinogen turnover

should be monitored with fibrinogen assays.

To calculate cryoprecipitate dosage as a source of Factor

VIII, the following formula is helpful:

Number of bags of cryoprecipitate required =

desired increased Factor VIII level (in %) ×

patient’s plasma volume (in mL)*

average units of Factor VIII per cryoprecipitate (minimum 80)

For example: 50% × 2800 mL or 0.50U/mL × 2800 mL = 18 bags

80 80 U/bag

*or substitute 4% body weight (kg) × 1000

Good patient management requires that the Cryoprecipitated AHF treatment responses of Factor VIII-deficient recipients be monitored with periodic plasma Factor VIII assays.

For treatment of von Willebrand disease, smaller

amounts of Cryoprecipitated AHF will correct the bleeding

time. These patients should be monitored by appropriate laboratory studies to determine frequency of Cryoprecipitated

AHF administration.

Side Effects and Hazards

Hazards that pertain to all transfusion components are described in the earlier section on Side Effects and Hazards.

If a large volume of ABO-incompatible cryoprecipitate is

used, the recipient may develop a positive DAT and, very

rarely, mild hemolysis.

Platelet Components

Platelets (PLATELETS)

Description

A unit of Platelets is a concentrate of platelets separated from

a single unit of Whole Blood and suspended in a small

amount of the original plasma. One unit of Platelets should

contain no fewer than 5.5 × 1010 platelets suspended in 40-70

mL of plasma, which contain normal levels of stable coagulation factors. Depending upon the technique used in prepa28
ration, each platelet unit may contain a significant number of

leukocytes. Some platelet units may contain more than the

trace amounts of red cells usually present, which will appear

pink-to-salmon colored. This component may be prepared

from Whole Blood collected in all approved anticoagulant

solutions.

Actions

Platelets are essential for normal hemostasis. Complex reactions occur between platelets, von Willebrand factor, and

collagen in the walls of disturbed vasculature, phospholipid,

and soluble coagulation factors including thrombin. These

changes induce platelet adherence to vessel walls and

platelet activation, which leads to platelet aggregation and

formation of a primary hemostatic plug. The therapeutic goal

of platelet transfusion is to provide adequate numbers of normally functioning platelets for the prevention or cessation of

bleeding.

Indications

Platelet transfusion is indicated for treatment of patients

bleeding due to critically decreased circulating platelet

count or functionally abnormal platelets. Platelet transfusions are not usually effective or indicated in patients with

destruction of circulating platelets due to autoimmune disorders, eg, immune thrombocytopenic purpura (ITP).

Platelets may be useful if given prophylactically to patients with rapidly decreasing or low platelet counts (usually

less than 10,000/μL) secondary to cancer, marrow aplasia, or

chemotherapy. Platelet transfusion may also be useful in selected cases of postoperative bleeding, eg, platelet count less

than 50,000/μL. If platelet function is normal, platelets

should not be transfused if the platelet count is greater than

100,000/μL.

Contraindications

Do not use this component if bleeding is unrelated to decreased numbers of, or abnormally functioning, platelets.

Do not use in patients with destruction of endogenous or

transfused platelets, such as in TTP or ITP, unless the patient

has a life-threatening hemorrhage.

Dosage and Administration

Compatibility testing is not necessary in routine platelet

transfusion. Except in unusual circumstances, the donor

plasma should be ABO compatible with the recipient’s red

cells when this component is to be transfused to infants or

when large volumes are to be transfused. The number of

platelet units to be administered depends on the clinical situation of each patient. One unit of Platelets would be expected

29
to increase the platelet count of a 70-kg adult by 5-10,000/μL

and increase the count of an 18-kg child by 20,000/μL. The

usual dose in an adult patient is 4-8 units. For prophylaxis,

this dose may need to be repeated in 1-3 days because of the

short lifespan of transfused platelets (3-4 days).

The corrected count increment (CCI) is a calculated measure of patient response to platelet transfusion that adjusts

for the number of platelets infused and the size of the recipient.

CCI = (post-count – pre-count) × BSA / platelets transfused

where post-count and pre-count are platelet counts (/μL) after and before transfusion, respectively; BSA is the patient

body surface area (meter2

); and platelets transfused is the

number of administered platelets (× 1011). For example:

A patient with acute myelogenous leukemia with a

nomogram-derived body surface area of 1.40 meter2 is transfused with a unit of Platelets Pheresis. The collecting facility

label indicates a platelet dose of 4.5 × 1011. The pretransfusion platelet count is 2000/μL. The patient’s platelet

count from a sample of blood collected 15 minutes after

platelet transfusion is 29,000/μL. The CCI is calculated as

(29,000 – 2,000) × 1.4 / 4.5 = 8400.

In the clinically stable patient, the CCI is typically greater

than 7500 at 10 minutes to one hour after transfusion and remains above 4500 at 24 hours. Both immune and nonimmune

mechanisms may contribute to reduced platelet recovery and

survival. Along with supportive serologic test results, a CCI

of lower than 5000 at 10 minutes to 1 hour after transfusion

may indicate an immune-mediated refractory state to platelet

therapy. With nonimmune mechanisms, platelet recovery

within 1 hour may be adequate although survival at 24 hours

is reduced. Platelets must be examined prior to administration. Units with excessive aggregates should not be administered. Transfusion may proceed as fast as tolerated but must

take less than 4 hours.

Side Effects and Hazards

Hazards that pertain to all transfusion components are described in the section on Side Effects and Hazards. Listed below are hazards that apply specifically to components that

contain platelets.

1. Bacterial Contamination: Platelet products are the

most likely among blood components to be contaminated with bacteria. Gram-positive skin flora are the

most commonly recovered bacteria from contaminated platelet units. Symptoms may include high fever

(≥2.0 C or ≥3.5 F rise in temperature), severe chills,

hypotension, or circulatory collapse during or immediately after transfusion. Prompt management should include broad-spectrum antibiotic therapy along with

cultures of patient sample, suspected blood compo30
nent(s), and administration set. Gram’s stain of suspected contaminated unit(s) may be helpful.

2. Platelet Alloimmunization: Platelets bear a variety

of antigens, including HLA and platelet-specific antigens. Patients transfused with platelets often develop

HLA antibodies. The patient may become refractory to

all but HLA-selected platelets (see “Platelets

Pheresis”). When platelets are transfused to a patient

with an antibody specific for an expressed antigen, the

survival time of the transfused platelets may be markedly shortened. Nonimmune events may also contribute to reduced platelet survival. It is possible to suggest the presence of immune or nonimmune platelet

refractoriness by assessing platelet recovery soon after infusion, ie, 10- to 60-minute postinfusion platelet

increment. In immune refractory states secondary to

serologic incompatibility, there is poor recovery in the

early postinfusion interval. In nonimmune mechanisms (ie, splenomegaly, sepsis, fever, intravascular

devices, and DIC) platelet recovery within 1 hour of

infusion may be adequate while longer-term survival

(ie, 24-hour survival) is reduced. Serologic tests can

confirm the presence of alloimmunization. Serologic

tests may also be helpful in selecting platelets with acceptable survival.

3. Red Cell Alloimmunization: Immunization to red

cell antigens may occur because of the presence of residual red cells in Platelets. When Platelet units from

Rh-positive donors must be given to an Rh-negative

female of childbearing potential because of lack of

availability of Rh-negative Platelets, prevention of D

immunization by use of Rh Immune Globulin should

be considered. In some patients, out-of-group Platelets

suspended in incompatible plasma that contains anti-A

or anti-B may cause a positive DAT and possibly

low-grade hemolysis if the recipient’s red cells express the corresponding antigen.

Components Available

1. Platelets (PLATELETS)

A unit of Platelets is a concentrate of platelets separated from a single unit of Whole Blood. One unit of

Platelets should contain no fewer than 5.5 × 1010 platelets suspended in 40-70 mL of plasma.

2. Platelets Pooled (POOLED PLATELETS)

Platelets Pooled is composed of individual platelet

units combined by sterile technique and has an allowable shelf life of 4 hours. The number of units of Platelets in the pool will be indicated on the label. To determine the minimum potency of this component, assume

5.5 × 1010 platelets per unit of Platelets indicated on

the label. See the label for the approximate volume.

31
3. Platelets Pheresis (APHERESIS PLATELETS)

Apheresis is an effective way to harvest a therapeutic

adult dose of platelets from a single donor. Platelets

Pheresis should contain ≥ 3 × 1011 platelets. One unit

of Platelets Pheresis may replace 4-8 units of Platelets.

The exact number of platelets in the apheresis product

can be obtained on request from the collecting facility.

The volume of plasma used for platelet suspension varies between 100 and 500 mL. (See the label for the approximate volume.) The number of leukocytes contained in this component varies depending upon the

blood cell separator and protocol used for collection.

Platelets Pheresis is supplied in a large plastic pack or

in two connected packs to improve platelet viability

during storage by providing more surface area for gas

exchange. ACD-A is the anticoagulant solution currently used for the collection and preservation of Platelets Pheresis.

In patients refractory to platelets from unmatched

donors, this component may be especially useful if selected to be HLA-matched or if determined recipient-compatible by serologic methods. Other causes of

refractoriness to Platelets include DIC, ITP, hypersplenism, fever, and sepsis; for these latter conditions,

Platelets Pheresis is no more effective than Platelets.

Red blood cell compatibility testing is necessary

only if the component is prepared by a method that allows the component to contain 2 mL or more of red

cells.

4. Platelets Pheresis Leukocytes Reduced (APHERESIS

PLATELETS, LEUKOCYTES REDUCED), Platelets Leukocyte Reduced (PLATELETS, LEUKOCYTES REDUCED)

Platelets and Platelets Pheresis can be prepared to be

leukocyte reduced. Platelets and Platelets Pheresis

may also be further processed using leukocyte reduction filters. These may be labeled Platelets Leukocytes

Reduced or Platelets Pheresis Leukocytes Reduced

provided that the residual leukocyte count is <8.3 × 105

or <5 × 106, respectively, and the platelet recovery is at

least 85% of the prefiltration content. Alternatively,

Platelets Pheresis may be collected to contain a therapeutic adult dose of platelets and very few leukocytes.

If the leukocyte content is <5 × 106 and the platelet

count is >3 × 1011 platelets, the unit can be labeled

Platelets Pheresis Leukocytes Reduced. The volume,

anticoagulant/preservative, and storage conditions for

leukocyte-reduced platelet components are the same

as those for Platelets or Platelets Pheresis,

respectively. Platelets Leukocytes Reduced or Platelets Pheresis Leukocytes Reduced are indicated to decrease the frequency of recurrent febrile, nonhemolytic transfusion reaction, HLA alloimmunization and

transfusion-transmitted CMV infection. (See section

on Further Processing.)

32
Granulocyte Components

Description

Granulocyte transfusion therapy is controversial. Granulocyte concentrates are typically collected by a hemapheresis

technique. Granulocytes Pheresis usually contains many

other leukocytes and platelets as well as 20-50 mL of red

cells. The number of granulocytes in each concentrate is ≥1.0

× 1010. Various modalities may be used to improve granulocyte harvest, including donor administration of granulocyte

colony-stimulating factor and/or corticosteroids. The final

volume of the Granulocytes Pheresis product is 200-300 mL

including anticoagulant and plasma as indicated on the label.

Red cell sedimenting agents approved by the FDA, such

as hydroxyethyl starch (HES), are typically used in the collection of granulocytes. Residual agent will be present in the

final component and is described on the label. Granulocytes

Pheresis should be administered as soon after collection as

possible due to well-documented deterioration of granulocyte function on short-term storage. If stored, maintain at

20-24 C without agitation for no more than 24 hours.

The component Granulocytes/Platelets Pheresis is similar to both Granulocytes Pheresis and Platelets Pheresis in

actions, side effects, hazards and the need for irradiation. It is

indicated for patients with simultaneous need for both of

these components. The expected potency of the component is

usually greater than 3 × 1011 platelets and 1 × 1010 granulocytes. Administration is the same as for Granulocytes

Pheresis, since granulocyte therapy is the primary therapeutic consideration.

Actions

Granulocytes migrate toward, phagocytize, and kill bacteria

and fungi. A quantitative relationship exists between the

level of circulating granulocytes and the prevalence of bacterial and fungal infection in neutropenic patients.

The infusion of a granulocyte concentrate in itself is

rarely associated with an increment in the patient’s granulocyte count. This may be due to the sequestration of granulocytes that results from prior immunization to leukocyte antigens or due to consumption of granulocytes in the infection

process.

Indications

Granulocytes Pheresis is used typically in the treatment of

neutropenic patients (generally less than 0.5 × 109

/L

[500/μL]) in whom eventual marrow recovery is expected,

who have documented infections (especially gram-negative

bacteria and fungi), and who have not responded to antibiot33
ics. A trial of broad-spectrum antimicrobial agents should be

used before granulocyte transfusion therapy is initiated. If

the intended recipient is CMV-seronegative and severely

immunosuppressed (eg, a marrow transplant recipient),

CMV-seropositive granulocytes should not be given. In addition to neutropenic patients, patients with hereditary

neutrophil function defects (such as chronic granulomatous

disease) may be candidates to receive granulocyte transfusion therapy. Prophylactic use of granulocytes in noninfected patients is not recommended.

Dosage and Administration

Transfuse as soon as possible. A standard blood infusion set

is to be used for the administration of Granulocytes Pheresis

because depth-type microaggregate filters and leukocyte reduction filters remove granulocytes. The red cells in Granulocytes Pheresis must be ABO-compatible with the recipient’s antibodies. Once granulocyte transfusion therapy is

initiated, support should continue at least daily until infection is cured, defervescence occurs, the absolute granulocyte

count returns to at least 0.5 × 109

/L (500/μL), or the physician

in charge decides to halt the therapy.

Because most patients receiving these products are severely immunosuppressed, Granulocytes Pheresis should be

irradiated to prevent graft-vs-host disease (see section on

Further Processing).

Side Effects and Hazards

Hazards that pertain to all transfusion components are described in the section on Hazards and Side Effects. Listed below are hazards that apply specifically to granulocyte concentrates.

1. Febrile Nonhemolytic Reactions: These reactions

are frequently noted in patients receiving granulocyte

transfusions. The occurrence of chills, fever, and pulmonary insufficiency in patients receiving

granulocyte components may be avoided or lessened

by slow administration and the use of recipient medication such as meperidine.

2. Allergic Reactions: Allergic reactions to HES and

other red cell sedimenting solutions may occur during

granulocyte transfusion.

Further Processing

This section addresses further processing of previously described blood components. One or more of these processes

may be performed on a component.

34
Leukocyte Reduction

Examples of Leukocyte-Reduced Components:

Red Blood Cells Leukocytes Reduced; (RED

BLOOD CELLS LEUKOCYTES REDUCED)

Platelets Leukocytes Reduced; (PLATELETS

LEUKOCYTES REDUCED)

Platelets Pheresis Leukocytes Reduced

(APHERESIS PLATELETS LEUKOCYTES REDUCED)

Description

A unit of whole blood contains ≥1-10 × 109white cells. Leukocyte reduction may be achieved by in-process collection

or filtration: 1) soon after collection (prestorage), 2) after

varying periods of storage in the laboratory, or 3) at the bedside. The method used in the laboratory for leukocyte reduction is subject to quality control testing; leukocyte-reduced

components prepared at the bedside may not be quality controlled. Leukocyte reduction will decrease the cellular content and volume of blood according to characteristics of the

filter system used. Whole Blood, Red Blood Cells, and Platelets Pheresis Leukocytes Reduced must have a residual content of leukocytes <5 × 106

. Platelets Leukocytes Reduced

must have <8.3 × 105

residual leukocytes. Leukocyte reduction filters variably remove other cellular elements in addition to white cells. The leukocyte-reduced component will

have therapeutic efficacy equal to at least 85% of the original

component. Currently, washing is not a substitute for leukocyte reduction and leukocyte reduction is not a substitute for

irradiation.

Indications

Leukocyte-reduced components are indicated to decrease

the frequency of recurrent febrile nonhemolytic transfusion

reactions. These components have been shown to reduce the

incidence of HLA alloimmunization. They have also been

shown to reduce the risk of transfusion-transmissible CMV.

These components may also be beneficial in reducing transfusion-related immunomodulation, but this use should be

considered experimental.

Contraindications

Leukocyte-reduced components do not prevent GVHD. Leukocyte reduction filters are not to be used in the administration of Granulocytes Pheresis.

Side Effects and Hazards

The use of blood components that are leukocyte reduced at

the bedside may cause unexpected severe hypotension in

35
some recipients, particularly those on ACE inhibitor medication.

Further Testing to Identify CMV-Seronegative

Blood

Description

CMV-seronegative blood is selected by performing testing

for antibodies to CMV (using a CMV test approved for donor

screening). Transmission of CMV disease is associated with

cellular blood components. FFP, cryoprecipitate, and other

plasma-derived blood components do not require special

testing.

Indications

Transfusion of CMV-negative blood is indicated in CMVseronegative recipients who are at risk for severe CMV infections. These at-risk groups include pregnant women and

their fetuses, low birthweight infants, marrow transplant recipients, solid-organ transplant recipients, severely

immunosuppressed recipients, and HIV-infected patients.

Irradiation

Description

Blood components that contain viable lymphocytes may be

irradiated to prevent proliferation of T lymphocytes, which

is the immediate cause of GVHD. Irradiated blood is prepared by exposing the component to a source of irradiation.

The standard dose of gamma irradiation is 2500 cGy targeted

to the central portion of the container with a minimum dose

of 1500 cGy delivered to all other parts of the component.

Maximum allowable dose is 5000 cGy.

Indications

Irradiated blood is indicated for use in patient groups that are

at risk for GVHD from transfusion. At-risk groups include:

fetuses receiving intrauterine transfusions, selected

immunoincompetent or immunocompromised recipients, recipients of cellular components known to be from a blood relative, recipients who have undergone marrow or peripheral

blood progenitor cell transplantation, and recipients of cellular components whose donor is selected for HLA compatibility.

Side Effects and Hazards

Irradiation induces erythrocyte membrane damage. Irradiated red cells have been shown to have higher supernatant

potassium levels than nonirradiated red cells. Removal of residual supernatant plasma prior to transfusion may reduce

36
the risks associated with elevated plasma potassium. The expiration date of irradiated red cells is changed to 28 days

postirradiation if available shelf life exceeds 28 days.

Washing

Examples of Washed Components:

Red Blood Cells Washed (WASHED RED BLOOD

CELLS)

Platelets Washed (WASHED PLATELETS)

Platelets Pheresis Washed (WASHED APHERESIS

PLATELETS)

Description

Washed components are typically prepared using 0.9% Sodium Chloride, Injection (USP) with or without small

amounts of dextrose. Washing removes unwanted plasma

proteins, including antibodies. There will also be some loss

of red cells and platelets, as well as a loss of platelet function

through platelet activation. The hermetic seal of the components has been broken; therefore, shelf life is no more than 24

hours at 1-6 C or 4 hours at 20-24 C. Washing is not a substitute for leukocyte reduction.

Indications

Washing of blood components is indicated to remove unwanted plasma when it contains constituents that predispose

patients to significant transfusion reactions, eg, the removal

of IgA-containing plasma in providing transfusion support

for an IgA-deficient recipient or in rare recipients experiencing anaphylactoid reactions to plasma components.

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Circular of Information

July 2002