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

Withdrawn before enrolling · Phase 1

Conditions studied: Transfusion Reaction, Anemia

In brief

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.

Key facts

Study ID

NCT03056378

Run by

New York Blood Center

People needed

0

Starts

2019-10-01

Expected to finish

2021-06-01

Last updated by the study team

2019-12-26

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Westchester Medical Center/New York Medical College — Valhalla, New York, United States

Full record on ClinicalTrials.gov

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