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 range

18 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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