POOLED Red Blood Cells Prepared From Pooling 5 Leukoreduced, Irradiated RBC Units (Pooled RBCs)

December 23, 2019 updated by: New York Blood Center

Phase I Clinical Trial of Pooled Red Blood Cells for Transfusion

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Valhalla, New York, United States, 10595
        • Westchester Medical Center/New York Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pooled RBCs
Transfusion of an investigational transfusion blood component: POOLED-RBCs Phenotype matched/ compatible for ABO, D, C, E, and K (blood type of pool will be match patient's type), leukoreduced, and irradiated
Biological: Standard RBCs
Transfusion of standard pRBCs that are matched for C, E and K
Active Comparator: Standard RBCs
Transfusion of standard transfusion blood component: additive solution leukoreduced, irradiated RBC product Phenotype matched/ compatible for ABO, D, C, E, and K (blood type of pool will be match patient's type)
Biological: Standard RBCs
Transfusion of standard pRBCs that are matched for C, E and K

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quantitation of adverse events
Time Frame: 60 day endpoint
60 day endpoint

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York Blood Center

Collaborators

Westchester Medical Center

Investigators

  • Principal Investigator: Beth Shaz, M.D., New York Blood Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2019

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

January 13, 2017

First Submitted That Met QC Criteria

February 14, 2017

First Posted (Actual)

February 17, 2017

Study Record Updates

Last Update Posted (Actual)

December 26, 2019

Last Update Submitted That Met QC Criteria

December 23, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NYBC-0088

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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