Clinical trial NCT01534676: Effects of Transfusion of Older Stored Red Cells
Official title: Harmful Effects of Transfusion of Older Stored Red Cells: Iron and Inflammation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sickle Cell Disease
Thalassemia
Keywords: iron
transfusion
red blood cells
sickle cell disease
thalassemia
blood donors
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2012-02-17
Enrollment: 3
Sex: ALL
Minimum age (years): 1
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effects of transfusion of fresh and stored blood on patients.

The investigators hope to test:

* whether a similar effect (older stored blood is associated with worse outcomes) is seen in chronically transfused patients with hemoglobinopathies. This patient population will also allow the investigators to test whether iron- chelation therapy is beneficial in this setting.
* whether washing or cryopreserving the red blood cells has any effect on this outcome.

These findings may explain the immunomodulatory effects of older stored blood in patients and will help us develop safer transfusion products for patients.

Detailed description: Epidemiologic studies suggest that older stored blood is associated with worse outcomes in certain hospitalized patients. Storage of red cells is associated with a storage lesion and the survival of transfused red cells decreases with increasing storage time, thus older blood is associated with an increased acute delivery of hemoglobin-iron to the reticuloendothelial system. The investigators have preliminary data in healthy human volunteers suggesting that delivery of a significant iron load to the reticuloendothelial system from aged red cells leads to the elaboration of a potentially toxic form of iron known as non-transferrin-bound iron.

Eligibility criteria: Inclusion Criteria (Recipient):

* specific, well-characterized hemoglobinopathy
* chronic simple transfusion therapy (transfusion episodes \< 6 weeks apart in frequency)
* chronic iron chelation therapy
* not pregnant by self-report and not planning pregnancy
* age \> 1 year old

Exclusion Criteria (Recipient):

* clinically unstable
* treatment for mental illness
* imprisonment
* institutionalization

Inclusion Criteria (Donor):

* 21-65 years of age
* male weight \> 130 lbs, female weight \> 150 lbs
* male height \> 5'1", female height \> 5'5"
* hemoglobin \> 15.0 g/dL
* reasonably certain of intention to stay in New York City metropolitan area for study duration
* previously tolerated red blood cell donation

Exclusion Criteria (Donor):

* ineligible for donation based on New York Blood Center blood donor screening questionnaire
* systolic blood pressure \< 90 or \> 180 mm Hg, diastolic blood pressure \< 50 or \> 100 mm Hg
* heart rate \< 50 or \> 100
* temperature \> 99.5 F prior to donation
* positive by standard infectious disease testing performed on blood donors

Primary outcomes:
measure: Non-transferrin-bound Iron Level
timeFrame: 2 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: Steven Spitalnik, MD
role: PRINCIPAL_INVESTIGATOR
References: