POOLED Red Blood Cells Prepared From Pooling 5 Leukoreduced, Irradiated RBC Units

Study Overview
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Brief Summary
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The purpose of the study is to determine the safety of pooled red blood cells (RBCs) compared to standard leukoreduced RBC products stored in additive solution. The primary objective is to determine if there is no significant difference in transfusion associated adverse events in POOLED-RBCs compared to standard RBC product groups. Secondarily to determine if there are no significant differences in new antibody and new positive direct antiglobulin test (DAT) formation in the POOLED-RBCs compared to standard RBC product groups.

Detailed Description
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This research study is enrolling subjects who are receiving RBC (red blood cell) blood transfusions as part of their treatment. In this study, we are testing a new way of preparing RBC units (pooled RBC units) for transfusion compared to the standard RBC units. We are testing this because blood transfusions may be associated with side effects that may be harmful. We have developed a new way to process RBC for transfusion to try and reduce some of those side effects. The pooled RBC units will be made by sterilely pooling five (5) single RBC units into one container where the blood will be mixed together, and then separated into five individual RBC units, ready to be used for transfusion. The purpose of the study is to determine the safety of the blood prepared in this new way compared to standard RBC products. The primary objective is to determine if there is no significant difference in transfusion associated adverse events in POOLED-RBCs compared to standard RBC product groups. Secondarily to determine if there are no significant differences in new antibody and new positive direct antiglobulin test (DAT) formation in the POOLED-RBCs compared to standard RBC product groups.

Official Title
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Phase I Clinical Trial of Pooled Red Blood Cells for Transfusion

Conditions
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Transfusion Reaction, Anemia

Intervention / Treatment
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* Biological: Standard RBCs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age>= 18 years Hematology/ oncology or other chronic transfusion dependent patients Patients who are in need of transfusion due to low hemoglobin level (<8 gm/dl) Patients who only require one or two transfusion episode of 1-2 RBC units each during 60 day period Currently not planning to be pregnant during the study period Exclusion Criteria: Previously identified alloantibodies (other than to D, C, E and K) Positive direct antiglobulin test, currently or within the last year Emergency transfusion Patients < 18 years old Need for specialized products, such as washed Patients involved in other RBC transfusion clinical trial Currently or planning to be pregnant within the proposed study period

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pooled RBCs<br>Transfusion of an investigational transfusion blood component: POOLED-RBCs Phenotype matched/ compatible for ABO, D, C, E, and K (blood type of pool will be match patient's type), leukoreduced, and irradiated | Biological: Standard RBCs<br>* Transfusion of standard pRBCs that are matched for C, E and K<br>|
| Active Comparator: Standard RBCs<br>Transfusion of standard transfusion blood component: additive solution leukoreduced, irradiated RBC product Phenotype matched/ compatible for ABO, D, C, E, and K (blood type of pool will be match patient's type) | Biological: Standard RBCs<br>* Transfusion of standard pRBCs that are matched for C, E and K<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitation of adverse events |  | 60 day endpoint | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitation of RBC alloantibody formation | Quantitation of new DAT formation | 15 and 30 minutes post-transfusion |