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

NCT03056378 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2019-12-26

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

Standard RBCs

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

Sponsors & Collaborators

  • Westchester Medical Center

    collaborator OTHER

  • New York Blood Center

    lead OTHER

Principal Investigators

  • Beth Shaz, M.D. · New York Blood Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-31
Primary Completion
2020-12-31
Completion
2021-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03056378 on ClinicalTrials.gov