Delayed Cold-Stored Platelets -PLTS-1

Phase 2

Recruiting

• Conditions: Cardiopulmonary Bypass; Cardiac Surgery; Platelets; Bleeding
• Interventions: Biological: Delayed Cold-Stored Buffy Coat Platelets; Biological: Room Temperature Buffy Coat Platelets

• Registration Number: NCT06147531
• Lead Sponsor: University Health Network, Toronto

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-31
• Study First Submitted QC: 2023-11-23
• Study First Posted: 2023-11-27
• Study Start: 2024-06-05
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-25
• Last Update Posted: 2024-09-27
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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.

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Delayed Cold-Stored Buffy Coat Platelets	Patients randomized to the Delayed Cold-Stored Platelet Group will receive ABO-identical buffy-coat platelets (pathogen reduced products) maintained at 22°C for up to 4 days then placed at 4°C for a minimum of 1 day (24 hours), with expiration at 14 days after collection.
Control Group	Room Temperature Buffy Coat Platelets	Those randomized to the Room Temperature Platelet Group will receive ABO-identical buffy-coat platelets (pathogen reduced products) maintained at 22°C for up to 7 days (as per current standard of care).

Primary Outcome Measures

Name	Time	Method
Feasibility Outcome 2: Adequate cold-stored platelet supply	through study completion, an average of 1 year.	Adequate cold-stored platelet supply (defined as appropriate product available at the time of surgery for ≥90% of patients randomized to the cold-stored platelet group).
Feasibility Outcome 1: Adequate Patient Recruitment	through study completion, an average of 1 year.	Adequate recruitment (defined as ≥ 15% of eligible patients enrolled per centre per month to target consistent levels of enrollment).
Feasibility Outcome 3: Adequate clinician adherence to randomization assignment.	through study completion, an average of 1 year.	Adequate clinician adherence to randomization assignment (defined as \>90% of all randomized patients are administered the assigned product).

Trial Locations

Locations (2)

Kingston Health Sciences Centre; 🇨🇦 Kingston, Ontario, Canada

Toronto General Hospital - University Health Network; 🇨🇦 Toronto, Ontario, Canada