Autologous Whole Blood Management for Transfusion Reduction in Adult Cardiac Surgery Patients (NCT05889494) | Clinical Trial Compass
CompletedNot Applicable
Autologous Whole Blood Management for Transfusion Reduction in Adult Cardiac Surgery Patients
Canada64 participantsStarted 2025-03-24
Plain-language summary
The goal of this pilot trial is to test a protocol for a planned Canada-wide clinical trial looking at whether or not the use of a patients own blood works as good as the current standard of care using donated blood products to reduce blood loss in adult patients having heart surgery.
The main questions this study aims to answer are:
* Is the protocol practical, effective, and efficient.
* Does the use of a patients own blood lower the following: bleeding, the amount donated blood products given, and complications.
Participants will be separated into two groups by a process that is like flipping a coin. One group will donate blood to themselves in the operating room and get their own blood back after surgery. The other group will be given blood products donated by other humans to treat the bleeding after heart surgery.
Researchers will compare both groups to see if patients that get their own blood have fewer donated blood products given at time of heart surgery and have less complications after surgery.
Who can participate
Age range
18 Years – 85 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:
* Adult (≥18 yr)
* Surgical patients at the Mazankowski Alberta Heart Institute
* High risk for acquired coagulopathy
Exclusion Criteria:
* Left ventricular ejection fraction \<20%
* Impaired renal function
* Preoperative anemia (hematocrit \< 30%)
* Abnormal coagulation studies or platelet function
* Presence of hemoglobinopathy
* Platelet count \< 120 10\*9/L
* Non-heparin based CPB anticoagulation
* Presence of carotid stenosis (≥70%)
* Presence of bacteremia/endocarditis
* Age \> 85 yr
* Weight \< 55 kg
* Hepatic failure/dysfunction
* Pregnancy
* Chronic lung disease on home O2
* Acute respiratory failure
* Acute coronary syndromes
* Emergency surgery
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.