Actively Recruiting
Delayed Cold-Stored Platelets -PLTS-1
Led by University Health Network, Toronto · Updated on 2025-12-29
150
Participants Needed
2
Research Sites
129 weeks
Total Duration
On this page
Sponsors
U
University Health Network, Toronto
Lead Sponsor
K
Kingston Health Sciences Centre
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 feasibility of a future, definitive RCT to determine the non-inferiority of cold-stored platelets compared to conventional platelets with respect to hemostatic effectiveness (total number of allogeneic blood products transfused within 24 hours after CPB), as well as safety.
CONDITIONS
Official Title
Delayed Cold-Stored Platelets -PLTS-1
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older undergoing elective cardiac surgery with cardiopulmonary bypass
- Planned surgery must be at least moderately complex, including valve repair/replacement, aorta replacement, combined coronary artery bypass grafting, or re-do cardiac procedures
- Preoperative platelet count of 150,000 x10^6/L or lower
You will not qualify if you...
- Cold-stored platelets unavailable at time of surgery
- Congenital or acquired bleeding disorders including platelet refractoriness and need for specially matched platelets
- Known contraindication to heparin or use of non-reversible anticoagulants
- Use of warfarin or direct oral anticoagulants within 3 days prior to surgery
- Use of antiplatelet drugs within 5 days prior to surgery (except aspirin)
- Refusal of allogeneic blood products
- Known pregnancy
- Previous enrollment in this study
- Participation in another interventional clinical trial altering routine care
- Hemodynamic instability requiring critical care or vasoactive drugs before surgery
- Preoperative or expected postoperative dependence on mechanical circulatory support
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Kingston Health Sciences Centre
Kingston, Ontario, Canada, K7L 2V7
Actively Recruiting
2
Toronto General Hospital - University Health Network
Toronto, Ontario, Canada, M5G 2C4
Actively Recruiting
Research Team
K
Keyvan Karkouti, MD
CONTACT
D
Deep Grewal
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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