POOLED Red Blood Cells Prepared From Pooling 5 Leukoreduced, Irradiated RBC Units
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Anemia |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 8/31/2018 |
| Start Date: | October 2019 |
| End Date: | June 2021 |
| Contact: | Beth Shaz, M.D. |
| Email: | BShaz@nybc.org |
| Phone: | 212-570-3460 |
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.
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.
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.
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.
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
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