Effects of Transfusion of Older Stored Red Cells

Study Overview
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Brief Summary
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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
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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.

Official Title
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Harmful Effects of Transfusion of Older Stored Red Cells: Iron and Inflammation

Conditions
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Sickle Cell Disease, Thalassemia

Intervention / Treatment
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* Procedure: Transfusion
* Biological: Blood
* Procedure: Chelation therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Transfusion of Fresh blood<br>The recipient will receive one or two units of fresh blood <14 days old, as per their chronic transfusion schedule - on or off chelation therapy. | Procedure: Transfusion<br>* A routine medical procedure to transfuse packed red blood cells.<br>* Other names: RBC transfusion;Biological: Blood<br>* Processing of RBC for transfusion include the following: Fresh Stored Washed Frozen (Cryopreserved)<br>* Other names: Reb Blood Cells;Procedure: Chelation therapy<br>* (non-experimental) A medical procedure that involves the administration of chelating agents to remove heavy metals from the body.<br>|
| Experimental: Transfusion of Stored blood<br>The recipient will receive one or two units of old blood >28 days old, as per their chronic transfusion schedule - on or off chelation therapy. | Procedure: Transfusion<br>* A routine medical procedure to transfuse packed red blood cells.<br>* Other names: RBC transfusion;Biological: Blood<br>* Processing of RBC for transfusion include the following: Fresh Stored Washed Frozen (Cryopreserved)<br>* Other names: Reb Blood Cells;Procedure: Chelation therapy<br>* (non-experimental) A medical procedure that involves the administration of chelating agents to remove heavy metals from the body.<br>|
| Active Comparator: Transfusion of Cryopreserved Blood<br>The recipient will receive one or two units of cryopreserved (fresh/old) blood, as per their chronic transfusion schedule - off chelation therapy. | Procedure: Transfusion<br>* A routine medical procedure to transfuse packed red blood cells.<br>* Other names: RBC transfusion;Biological: Blood<br>* Processing of RBC for transfusion include the following: Fresh Stored Washed Frozen (Cryopreserved)<br>* Other names: Reb Blood Cells;|
| Active Comparator: Transfusion of Washed Blood<br>The recipient will receive one or two units of washed (fresh/old) stored blood >28 days old, as per their chronic transfusion schedule - off chelation therapy. | Procedure: Transfusion<br>* A routine medical procedure to transfuse packed red blood cells.<br>* Other names: RBC transfusion;Biological: Blood<br>* Processing of RBC for transfusion include the following: Fresh Stored Washed Frozen (Cryopreserved)<br>* Other names: Reb Blood Cells;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-transferrin-bound Iron Level |  | 2 hours after transfusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thalassemia, iron, transfusion, red blood cells, sickle cell disease, blood donors