Delayed cold-stored vs. room temperature stored platelet transfusions in bleeding adult cardiac surgery patients-a randomized multicentre pilot study (PLTS-1).
Justyna Bartoszko, Miki Peer, Deep Grewal...
https://pubmed.ncbi.nlm.nih.gov/38879518Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID06147531
A Clinical Comparison of Cold-Stored and Room Temperature-Stored Platelet Transfusions in Bleeding Adult Cardiac Surgery Patients
Led by University Health Network, Toronto · Updated on 2025-12-29
150
Participants Needed
2
Research Sites
26 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
Researchers are evaluating the feasibility of a future large trial comparing cold-stored platelets to conventional room temperature platelets for bleeding adult patients undergoing cardiac surgery with cardiopulmonary bypass. This pilot study aims to assess if cold-stored platelets are not inferior to conventional platelets in controlling bleeding, measured by the total number of blood products transfused within 24 hours after surgery. The study is conducted as a randomized, controlled, multicenter trial in Canada. Participants will be randomly assigned to receive either delayed cold-stored buffy-coat platelets or conventional room temperature buffy-coat platelets. Cold-stored platelets are initially kept at 22°C for up to 4 days then stored at 4°C for at least 1 day, with a total shelf life of up to 14 days after collection. Room temperature platelets are stored at 22°C for up to 7 days, consistent with current standard care. Both platelet types are pathogen reduced and ABO matched. During the study, researchers will monitor patient recruitment, platelet supply adequacy, and clinician adherence to the assigned treatment over about one year. They will evaluate the number of allogeneic blood products used within 24 hours after cardiopulmonary bypass as the primary outcome. Safety and feasibility aspects will also be assessed to support planning a future definitive trial. Participants will receive regular monitoring as part of their surgical care and platelet transfusion management.
CONDITIONS
Brief Title
Delayed Cold-Stored Platelets -PLTS-1
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older
- Undergoing elective cardiac surgery with cardiopulmonary bypass
- Planned for at least moderately complex surgery (such as multiple valve repair/replacement, aorta replacement, combined procedures, or re-do surgeries)
- Preoperative platelet count of at least 150,000 x106/L
You will not qualify if you...
- Cold-stored platelets not available at time of surgery
- Congenital or acquired bleeding disorders or platelet refractoriness due to antibodies
- Requirement for specially matched platelets (including IgA deficiency with anaphylaxis)
- Known contraindications to heparin or use of non-reversible anticoagulants
- Use of warfarin or direct oral anticoagulants within 3 days before surgery
- Use of antiplatelet drugs (except aspirin) within 5 days before surgery
- Refusal of allogeneic blood products
- Known pregnancy
- Prior enrollment in this study
- Enrollment in another interventional trial altering routine care
- Hemodynamic instability before surgery requiring critical care or vasopressors
- Pre- or expected post-operative dependence on mechanical circulatory support devices such as intra-aortic balloon pump or ventricular assist device
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to the day of surgery
Participants receive platelet transfusions with either delayed cold-stored platelets or room temperature-stored platelets during elective cardiac surgery.
1 treatment visit (in-person during surgery)
Follow-up
Duration - Up to 1 year
Participants are monitored after surgery for outcomes and safety related to platelet transfusions.
Follow-up visits as scheduled during routine post-operative care
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
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Research Team
K
Keyvan Karkouti, MD
D
Deep Grewal
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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