Status:
RECRUITING
Delayed Cold-Stored Platelets -PLTS-1
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Kingston Health Sciences Centre
Canadian Blood Services
Conditions:
Platelets
Bleeding
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
PLTS-1 is a multicentre, randomized, controlled, pilot trial, using a conventional, parallel group, two-armed design at 2 cardiac surgery centres in Canada. The study is designed to assess the feasibi...
Eligibility Criteria
Inclusion
- 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:
- repair/replacement of more than one valve;
- aorta (root/ascending/arch) replacement;
- any combination of coronary artery bypass grafting, valve repair/replacement, or aorta (root/ascending/arch) replacement; or
- re-do procedures consisting of a repair or revision of a prior cardiac intervention.
Exclusion
- Patients will be excluded if cold-stored platelets are not going to be available at the time of surgery or if the patient:
- 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),
- has known contraindications to heparin, thereby excluding cases where non-reversible anticoagulants (i.e. argatroban) are used,
- is on warfarin or direct oral anticoagulants (dabigatran, rivaroxaban, apixaban or edoxaban) within 3 days prior to surgery,
- is on antiplatelet drugs within 5 days prior to surgery (excluding acetylsalicylic acid \[ASA\]),
- refuses allogeneic blood products,
- has a known pregnancy,
- has already enrolled in this study,
- is enrolled in another interventional clinical trial where routine care and management are altered,
- has hemodynamic instability defined as critical care admission, vasopressor, or inotrope dependence prior to index surgery, or
- has pre-operative requirement for, or expected post-operative dependence upon mechanical circulatory support (i.e., intra-aortic balloon pump, ventricular assist device).
Key Trial Info
Start Date :
June 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06147531
Start Date
June 5 2024
End Date
December 1 2026
Last Update
December 29 2025
Active Locations (2)
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1
Kingston Health Sciences Centre
Kingston, Ontario, Canada, K7L 2V7
2
Toronto General Hospital - University Health Network
Toronto, Ontario, Canada, M5G 2C4