Clinical trial NCT03056378: POOLED Red Blood Cells Prepared From Pooling 5 Leukoreduced, Irradiated RBC Units
Official title: Phase I Clinical Trial of Pooled Red Blood Cells for Transfusion
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Transfusion Reaction
Anemia
Lead sponsor: New York Blood Center
Sponsor class: OTHER
Collaborators: name: Westchester Medical Center
First posted: 2017-02-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Quantitation of adverse events
timeFrame: 60 day endpoint
Secondary outcomes:
measure: Quantitation of RBC alloantibody formation
timeFrame: 15 and 30 minutes post-transfusion
Other outcomes:
Locations:
city: Valhalla
country: United States
facility: Westchester Medical Center/New York Medical College
state: New York
Study officials:
affiliation: New York Blood Center
name: Beth Shaz, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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