NCT03056378

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• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: New York Blood Center · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Transfusion Reaction
• Anemia

Interventions

Type	Name	Description
BIOLOGICAL	Standard RBCs	Transfusion of standard pRBCs that are matched for C, E and K

Timeline

• Start date: 2019-10-01
• Primary completion: 2020-12-01
• Completion: 2021-06-01
• First posted: 2017-02-17
• Last updated: 2019-12-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study