Using cold-stored platelets for cardiac surgery

A Clinical Comparison of Cold-stored and Room Temperature-stored Allogeneic Platelet Transfusions in Bleeding Adult Cardiac Surgery Patients - A Randomized Multicentre Pilot Study (PLTS-1 Study)

This study is testing whether using cold-stored platelets instead of regular room temperature platelets can safely help patients during heart surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Health Network, Toronto (Academic / other)
• Locations: 2 sites (Kingston, Ontario and 1 other locations)
• Trial ID: NCT06147531 on ClinicalTrials.gov

What this trial studies

This pilot trial evaluates the feasibility of using delayed cold-stored platelets compared to conventional room temperature platelets in patients undergoing elective cardiac surgery with cardiopulmonary bypass. The study is designed as a multicenter, randomized, controlled trial at two cardiac surgery centers in Canada, focusing on the hemostatic effectiveness and safety of cold-stored platelets. The primary outcome will assess the total number of blood products transfused within 24 hours after surgery, aiming to establish the non-inferiority of the cold-stored approach.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older undergoing elective cardiac surgery with a high risk of requiring platelet transfusions.

Not a fit: Patients with congenital or acquired hemostatic disorders or those for whom cold-stored platelets are unavailable will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve patient outcomes by providing a safer and more effective method of platelet transfusion during cardiac surgeries.

How similar studies have performed: While this approach is being explored, the use of cold-stored platelets in this specific context is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

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).

Where this trial is running

Kingston, Ontario and 1 other locations

• Kingston Health Sciences Centre — Kingston, Ontario, Canada (Recruiting)
• Toronto General Hospital - University Health Network — Toronto, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Justyna Bartoszko, MD — University Health Network, Toronto
• Study coordinator: Keyvan Karkouti, MD

Conditions Platelets; Bleeding; Cardiopulmonary Bypass; Cardiac Surgery; Blood Platelets; Cardiac surgical procedure; Blood Preservation/Methods; Blood Preservation/Adverse Effects