Delayed Cold-Stored Platelets -PLTS-1

University Health Network, Toronto

Status and phase: Enrolling; Phase 2

Conditions: Cardiac Surgery; Cardiopulmonary Bypass; Platelets; Bleeding

Treatments: Biological: Delayed Cold-Stored Buffy Coat Platelets; Biological: Room Temperature Buffy Coat Platelets

Study type: Interventional

Funder types: Other

Identifiers

NCT06147531

22-5855

Details and patient eligibility

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups

Intervention Group

Experimental group

Description:

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.

Treatment:

Biological: Delayed Cold-Stored Buffy Coat Platelets

Control Group

Active Comparator group

Description:

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).

Treatment:

Biological: Room Temperature Buffy Coat Platelets