Point-of-Care RBC Washing to Prevent Transfusion-Related Pulmonary Complications

Study Overview
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Brief Summary
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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.

Official Title
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Point-of-Care RBC Washing to Prevent Transfusion-Related Pulmonary Complications

Conditions
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Blood Transfusion Complications

Intervention / Treatment
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* Biological: Point-of-care washed red blood cell transfusion.
* Biological: Standard of care red blood cell transfusion.


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of care red blood cell transfusion<br>Red blood cells that are administered in the normal fashion. | Biological: Standard of care red blood cell transfusion.<br> <br> |
| Experimental: Point-of-Care washed red blood cell transfusion<br>Red blood cells that are washed at the point-of-care. | Biological: Point-of-care washed red blood cell transfusion.<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarkers Associated With Transfusion-Related Acute Lung Injury and Transfusion Associated Circulatory Overload. | This panel of biomarkers measures inflammation, altered coagulation, and endothelial activation all of which play key roles in the pathogenesis of lung injury. | 18 hours after the initiation of the first red blood cell transfusion. | 
| Number of Off-protocol Transfusions | 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. | Day of surgery. Approximately 1 day. | 
| Change in Recipient Hemoglobin | Change in Hemoglobin from pre-transfusion to post-transfusion | Pre to 6 hours post transfusion | 
| Change in Recipient Cell Free Hemoglobin(CFH) | Change in CFH from pre-transfusion to worst (highest/maximum) post-transfusion | Pre transfusion until study day 5 or hospital discharge, approximately 5 days | 
| Change in Haptoglobin | Change in Haptoglobin from pre-transfusion to worst (minimum) post-transfusion | Pre transfusion to study day 5 or hospital discharge, approximately 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Mechanical Ventilation | Number of hours subject received mechanical ventilation. | Up to hospital day 28, or discharge, whichever comes first | 
| Duration of Oxygen Supplementation | Number of hours subjects received supplemental oxygen. | Up to day 28, or hospital discharge, whichever comes first | 
| Sequential Organ Failure Assessment (SOFA) Score | 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. | Through postoperative day 5. | 
| Hospital Length of Stay | 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. | Up to day 28 | 
| Post Transfusion Respiratory Complications. | Development of transfusion-related lung injury (TRALI) or transfusion-associated circulatory overload (TACO). | Up to day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transfusion, RBC, cardiac, surgery, transfusion related acute lung injury (TRALI), transfusion associated circulatory overload (TACO)