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Point-of-Care RBC Washing to Prevent Transfusion-Related Pulmonary Complications
This study is designed to determine if point-of-care washing of allogeneic Leukocyte-Reduced Red Blood Cells reduces pulmonary complications when compared to standard-of-care Leukocyte-Reduced Red Blood Cells in a cardiac surgical population.
Details
| Lead sponsor | Mayo Clinic |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | COMPLETED |
| Enrolment | 171 |
| Start date | 2016-01 |
| Completion | 2019-05-30 |
Conditions
- Blood Transfusion Complications
Interventions
- Point-of-care washed red blood cell transfusion.
- Standard of care red blood cell transfusion.
Primary outcomes
- Biomarkers Associated With Transfusion-Related Acute Lung Injury and Transfusion Associated Circulatory Overload. — 18 hours after the initiation of the first red blood cell transfusion.
This panel of biomarkers measures inflammation, altered coagulation, and endothelial activation all of which play key roles in the pathogenesis of lung injury. - Number of "Off-protocol" Transfusions — Day of surgery. Approximately 1 day.
The number of standard issued red blood cell units that were transfused to study participants in the washed red blood cell arm of the trial. Additionally, emergency red blood cell transfusions in the standard issued arm of the trial that were administered outside of the study protocol were also included to the definition of "off protocol" transfusion. - Change in Recipient Hemoglobin — Pre to 6 hours post transfusion
Change in Hemoglobin from pre-transfusion to post-transfusion - Change in Recipient Cell Free Hemoglobin(CFH) — Pre transfusion until study day 5 or hospital discharge, approximately 5 days
Change in CFH from pre-transfusion to worst (highest/maximum) post-transfusion - Change in Haptoglobin — Pre transfusion to study day 5 or hospital discharge, approximately 5 days
Change in Haptoglobin from pre-transfusion to worst (minimum) post-transfusion
Countries
United States