Point-of-Care RBC Washing to Prevent Transfusion-Related Pulmonary Complications
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Blood Transfusion Complications
- Sponsor
- Mayo Clinic
- Enrollment
- 171
- Locations
- 2
- Primary Endpoint
- Biomarkers Associated With Transfusion-Related Acute Lung Injury and Transfusion Associated Circulatory Overload.
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Investigators
Daryl J. Kor, M.D.
Associate Professor of Anesthsiology
Mayo Clinic
Eligibility Criteria
Inclusion Criteria
- •Age equal to or greater than 18 years of age.
- •Scheduled to have cardiac bypass surgery at Mayo Clinic in Rochester, Minnesota or Duke University Medical Center in Durham, North Carolina
- •At risk for needing at least 4 units of blood during/after surgery
Exclusion Criteria
- •Emergency surgery
- •Immunoglobulin A (IgA) deficiency
- •History of severe recurrent transfusion reactions
- •Refusal to receive allogeneic blood products
- •Refusal to provide informed consent
- •Prevalent lung injury prior to randomization
- •Prevalent congestive heart failure prior to randomization
- •Expected hospital stay \< 48 hours
- •Not anticipated to survive \> 48 hours
- •Previously enrolled in this trial
Outcomes
Primary Outcomes
Biomarkers Associated With Transfusion-Related Acute Lung Injury and Transfusion Associated Circulatory Overload.
Time Frame: 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
Time Frame: 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
Time Frame: Pre to 6 hours post transfusion
Change in Hemoglobin from pre-transfusion to post-transfusion
Change in Recipient Cell Free Hemoglobin(CFH)
Time Frame: 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
Time Frame: Pre transfusion to study day 5 or hospital discharge, approximately 5 days
Change in Haptoglobin from pre-transfusion to worst (minimum) post-transfusion
Secondary Outcomes
- Duration of Mechanical Ventilation(Up to hospital day 28, or discharge, whichever comes first)
- Duration of Oxygen Supplementation(Up to day 28, or hospital discharge, whichever comes first)
- Sequential Organ Failure Assessment (SOFA) Score(Through postoperative day 5.)
- Hospital Length of Stay(Up to day 28)
- Post Transfusion Respiratory Complications.(Up to day 28)