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

Phase I Clinical Trial of Pooled Red Blood Cells for Transfusion

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03056378

Acronym

Pooled RBCs

Enrollment

Registered

2017-02-17

Start date

2019-10-31

Completion date

2021-06-30

Last updated

2019-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Transfusion Reaction

Brief summary

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

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.

Interventions

BIOLOGICALStandard RBCs

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Quantitation of adverse events	60 day endpoint

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026