Point-of-Care RBC Washing to Prevent Transfusion-Related Pulmonary Complications
- Conditions
- Blood Transfusion Complications
- Interventions
- Biological: Standard of care red blood cell transfusion.Biological: Point-of-care washed red blood cell transfusion.
- Registration Number
- NCT02094118
- Lead Sponsor
- Mayo Clinic
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 171
- 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
- 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
- No plan for placement of a pulmonary artery catheter
- Use of home oxygen therapy
- Complex RBC antibody profiles
- Need for the use of irradiated RBCs
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard of care red blood cell transfusion Standard of care red blood cell transfusion. Red blood cells that are administered in the normal fashion. Point-of-Care washed red blood cell transfusion Point-of-care washed red blood cell transfusion. Red blood cells that are washed at the point-of-care.
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Duration of Mechanical Ventilation Up to hospital day 28, or discharge, whichever comes first Number of hours subject received mechanical ventilation.
Duration of Oxygen Supplementation Up to day 28, or hospital discharge, whichever comes first Number of hours subjects received supplemental oxygen.
Sequential Organ Failure Assessment (SOFA) Score Through postoperative day 5. Worst SOFA score between Day 1 and Day 5. SOFA scores range from 0-24 with 0 meaning no organ dysfunction and 24 means severe dysfunction of all organ systems evaluated. Each of 6 organ systems are scored on a 0-4 scale with the cumulative score being the total SOFA score.
Hospital Length of Stay Up to day 28 Number of days subject remained in the hospital following their surgical procedure. If the number of days the subject remained in the hospital exceeded 28, a value of 28 is assigned.
Post Transfusion Respiratory Complications. Up to day 28 Development of transfusion-related lung injury (TRALI) or transfusion-associated circulatory overload (TACO).
Trial Locations
- Locations (2)
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States