Could cold platelets stop bleeding better in heart surgery?
NCT ID NCT06147531
First seen Jun 27, 2026 · Last updated Jul 14, 2026 · Updated 2 times
Summary
This study compares cold-stored platelets to standard room-temperature platelets for controlling bleeding in adults after heart surgery. About 150 patients will be randomly assigned to receive one type. The goal is to see if cold storage is a safe and effective option, and to plan a larger future study.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2024
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Adult (≥18 years old) patients undergoing elective cardiac surgery with CPB will be eligible for inclusion if they are planned to undergo at least moderately complex surgery or have a preoperative platelet count ≤150,000 x106/L (this is a group at high risk of requiring platelet transfusions post-CPB). Moderately complex index surgery is defined as: 1. repair/replacement of more than one valve; 2. aorta (root/ascending/arch) replacement; 3. any combination of coronary artery bypass grafting, valve repair/replacement, or aorta (root/ascending/arch) replacement; or 4. re-do procedures consisting of a repair or revision of a prior cardiac intervention. Exclusion Criteria: Patients will be excluded if cold-stored platelets are not going to be available at the time of surgery or if the patient: 1. has a congenital or acquired hemostatic disorder (including platelet refractoriness due to anti-platelet and anti-human leukocyte antigen \[HLA\] antibodies) and/or requires specially matched platelets (including patients with anaphylaxis to blood due to Immunoglobulin A \[IgA\] deficiency), 2. has known contraindications to heparin, thereby excluding cases where non-reversible anticoagulants (i.e. argatroban) are used, 3. is on warfarin or direct oral anticoagulants (dabigatran, rivaroxaban, apixaban or edoxaban) within 3 days prior to surgery, 4. is on antiplatelet drugs within 5 days prior to surgery (excluding acetylsalicylic acid \[ASA\]), 5. refuses allogeneic blood products, 6. has a known pregnancy, 7. has already enrolled in this study, 8. is enrolled in another interventional clinical trial where routine care and management are altered, 9. has hemodynamic instability defined as critical care admission, vasopressor, or inotrope dependence prior to index surgery, or 10. has pre-operative requirement for, or expected post-operative dependence upon mechanical circulatory support (i.e., intra-aortic balloon pump, ventricular assist device).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7, Canada
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Toronto General Hospital - University Health Network
Toronto, Ontario, M5G 2C4, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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