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

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ClinicalTrials.gov Identifier: NCT03056378
Recruitment Status : Withdrawn (No patients enrolled. Study withdrawn.)
First Posted : February 17, 2017
Last Update Posted : December 26, 2019
Sponsor:
Collaborator:
Westchester Medical Center
Information provided by (Responsible Party):
New York Blood Center

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.

Condition or disease Intervention/treatment Phase
Transfusion Reaction Anemia Biological: Standard RBCs Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Phase I Clinical Trial of Pooled Red Blood Cells for Transfusion
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Quantitation of adverse events [ Time Frame: 60 day endpoint ]

Secondary Outcome Measures :
  1. Quantitation of RBC alloantibody formation [ Time Frame: 15 and 30 minutes post-transfusion ]
    Quantitation of new DAT formation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03056378


Locations
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United States, New York
Westchester Medical Center/New York Medical College
Valhalla, New York, United States, 10595
Sponsors and Collaborators
New York Blood Center
Westchester Medical Center
Investigators
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Principal Investigator: Beth Shaz, M.D. New York Blood Center
Additional Information:
Publications:
Marthur A, Stassinopoulos A, Hess JR, Narla M, Shaz BH. Effects of pooling multiple red blood cell units to improve storage. Blood 2012;120:3437

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Responsible Party: New York Blood Center
ClinicalTrials.gov Identifier: NCT03056378    
Other Study ID Numbers: NYBC-0088
First Posted: February 17, 2017    Key Record Dates
Last Update Posted: December 26, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Transfusion Reaction
Hematologic Diseases
Immune System Diseases