CompletedPhase 1/2

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

United States171 participantsStarted 2016-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Biomarkers Associated With Transfusion-Related Acute Lung Injury and Transfusion Associated Circulatory Overload.

Timeframe: 18 hours after the initiation of the first red blood cell transfusion.

Number of "Off-protocol" Transfusions

Timeframe: Day of surgery. Approximately 1 day.

Change in Recipient Hemoglobin

Timeframe: Pre to 6 hours post transfusion

Change in Recipient Cell Free Hemoglobin(CFH)

Timeframe: Pre transfusion until study day 5 or hospital discharge, approximately 5 days

Change in Haptoglobin

Timeframe: Pre transfusion to study day 5 or hospital discharge, approximately 5 days

Trial details

NCT IDNCT02094118

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-05-30

Results submitted2021-02-08

View on ClinicalTrials.gov More Blood Transfusion Complications trials