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

New York Blood Center

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Conditions

Transfusion Reaction Anemia

Interventions

Standard RBCsBIOLOGICAL

Transfusion of standard pRBCs that are matched for C, E and K

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (1)

Westchester Medical Center/New York Medical College

Valhalla, New York, United States

Outcomes

Primary Outcomes

Quantitation of adverse events

Time frame: 60 day endpoint

Secondary Outcomes

Quantitation of RBC alloantibody formation

Quantitation of new DAT formation

Time frame: 15 and 30 minutes post-transfusion

Data from ClinicalTrials.gov

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