Point-of-Care RBC Washing to Prevent Transfusion-Related Pulmonary Complications
Completed · Phase 1/Phase 2
Conditions studied: Blood Transfusion Complications
In brief
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.
Key facts
- Study ID
- NCT02094118
- Run by
- Mayo Clinic
- People needed
- 171
- Starts
- 2016-01-01
- Expected to finish
- 2019-05-30
- Last updated by the study team
- 2021-04-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Mayo Clinic in Rochester — Rochester, Minnesota, United States
- Duke University Medical Center — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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