Clinical trial NCT01319552: Fresh Versus Old Red Blood Cells for Transfusion
Official title: Immunomodulatory Properties of Fresh Versus Stored Packed Red Blood Cells for Transfusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron, Abnormal Blood Level
Other Abnormal Blood Chemistry
Keywords: red blood cells
transfusion
storage
sickle cell disease
β-thalassemia
hemoglobin-associated iron
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2011-03-21
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Packed red blood cell units destined for transfusion can be stored for up to 42 days prior to transfusion based on Food and Drug Administration (FDA) guidelines. Recent studies suggest that certain patients transfused with blood stored for longer duration have poorer outcomes than patients transfused fresher blood. The investigators' hypothesis is that the delivery of an immediate and substantial load of hemoglobin-associated iron from a stored unit of blood leads to changes that explain the differences in outcome between patients transfused old versus fresh blood. The investigators propose to test this hypothesis in humans by transfusing an individual's own blood, both fresh and after storage, and comparing levels of various outcome measures.

Detailed description: Participants in this study will be asked to participate in a standard blood donation. The blood will be processed per standards at the investigators regional blood center (New York Blood Center) and then split into two equal units and shipped to Columbia University Medical Center for storage and transfusion. One unit will be transfused back into the same individual fresh (i.e. between 3-7 days after donation). The other unit will be transfused 42 days after donation. Blood samples will be drawn before, during, and after transfusion to measure levels of various analytes.

Eligibility criteria: Inclusion Criteria:

* healthy
* male body weight \>130 lbs, female body weight \> 155 lbs
* male height \>5'1", female height \>5'5"
* hemoglobin \>13.3 g/dL

Exclusion Criteria:

* ineligible for donation based on the New York Blood Center autologous blood donor questionnaire
* systolic blood pressure \>180 or \<90 mm Hg
* diastolic blood pressure \>100 or \<50 mm Hg
* heart rate \<50 or \>100
* temperature \>99.5 F prior to donation
* temperature \>100.4 F or subjective feeling of illness prior to transfusion
* positive results on standard blood donor infectious disease testing
* pregnancy.

Primary outcomes:
measure: Measure of Non-transferrin-bound Iron
timeFrame: four hours after transfusion
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Spitalnik L Spitalnik, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hod EA, Brittenham GM, Billote GB, Francis RO, Ginzburg YZ, Hendrickson JE, Jhang J, Schwartz J, Sharma S, Sheth S, Sireci AN, Stephens HL, Stotler BA, Wojczyk BS, Zimring JC, Spitalnik SL. Transfusion of human volunteers with older, stored red blood cells produces extravascular hemolysis and circulating non-transferrin-bound iron. Blood. 2011 Dec 15;118(25):6675-82. doi: 10.1182/blood-2011-08-371849. Epub 2011 Oct 20.