Delayed Cold-Stored Platelets -PLTS-1

NCT06147531 | Recruiting Phase 2 DMC

• 1 other identifier: 22-5855
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

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.

Conditions

Platelets; Bleeding; Cardiopulmonary Bypass; Cardiac Surgery

Keywords

Blood Platelets; Cardiac surgical procedure; Blood Preservation/Methods; Blood Preservation/Adverse Effects

Outcome Measures

Primary Outcomes (3)

• Feasibility Outcome 1: Adequate Patient Recruitment

  Adequate recruitment (defined as ≥ 15% of eligible patients enrolled per centre per month to target consistent levels of enrollment).

  through study completion, an average of 1 year.

• Feasibility Outcome 2: Adequate cold-stored platelet supply

  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).

  through study completion, an average of 1 year.

• Feasibility Outcome 3: Adequate clinician adherence to randomization assignment.

  Adequate clinician adherence to randomization assignment (defined as \>90% of all randomized patients are administered the assigned product).

  through study completion, an average of 1 year.

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Biological: Delayed Cold-Stored Buffy Coat Platelets

Control Group

ACTIVE COMPARATOR

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).

Biological: Room Temperature Buffy Coat Platelets

Interventions

Delayed Cold-Stored Buffy Coat Platelets BIOLOGICAL

To prepare cold-stored platelets, blood banks will transition conventional room temperature platelets up to 4 days after collection (with agitation) to cold-storage (at 1-6 C without agitation) for a minimum of 1 day (24 hours) and a maximum of 10 days after collection (for a total shelf life of ≤ 14 days after collection). Thus, cold-stored platelets will be produced and stored the same way as room temperature platelets up until their transition to cold-storage, ensuring similar products differing only in storage conditions and expiration date (as cold-stored platelets will have an expiration date beyond the current 5 days for pathogen inactivated platelets or 7 days for bacterially cultured platelets). Pathogen reduced platelets will be used for the pilot study (Canada is transitioning in 2022-23 to pathogen-reduced platelets and one site has already transitioned).

Intervention Group

Room Temperature Buffy Coat Platelets BIOLOGICAL

Room temperature stored platelets are prepared from donor whole blood, which is centrifuged to collect the buffy coat layer containing platelets. Seven ABO matched buffy coats from male and/or female donors are pooled in 280 ml of platelet additive solution and split into a single dose after pathogen inactivation, resulting in a product with a final platelet count of approximately 1300 x 109. Pathogen inactivated platelets (shelf-life of 5 days, with recent Health Canada approval for an extension of the shelf-life to 7 days), will be used as Canada is transitioning in 2022-23 to pathogen-inactivated platelets and one site has already transitioned.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Moderately complex index surgery is defined as:
• repair/replacement of more than one valve;
• aorta (root/ascending/arch) replacement;
• any combination of coronary artery bypass grafting, valve repair/replacement, or aorta (root/ascending/arch) replacement; or
• re-do procedures consisting of a repair or revision of a prior cardiac intervention.

You may not qualify if:

• Patients will be excluded if cold-stored platelets are not going to be available at the time of surgery or if the patient:
• 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),
• has known contraindications to heparin, thereby excluding cases where non-reversible anticoagulants (i.e. argatroban) are used,
• is on warfarin or direct oral anticoagulants (dabigatran, rivaroxaban, apixaban or edoxaban) within 3 days prior to surgery,
• is on antiplatelet drugs within 5 days prior to surgery (excluding acetylsalicylic acid \[ASA\]),
• refuses allogeneic blood products,
• has a known pregnancy,
• has already enrolled in this study,
• is enrolled in another interventional clinical trial where routine care and management are altered,
• has hemodynamic instability defined as critical care admission, vasopressor, or inotrope dependence prior to index surgery, or
• has pre-operative requirement for, or expected post-operative dependence upon mechanical circulatory support (i.e., intra-aortic balloon pump, ventricular assist device).

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Kingston Health Sciences Centre: collaborator
• Canadian Blood Services: collaborator

Study Sites (2)

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

RECRUITING

Toronto General Hospital - University Health Network

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

Related Publications (1)

• Bartoszko J, Peer M, Grewal D, Ansari S, Callum J, Karkouti K. Delayed cold-stored vs. room temperature stored platelet transfusions in bleeding adult cardiac surgery patients-a randomized multicentre pilot study (PLTS-1). Pilot Feasibility Stud. 2024 Jun 15;10(1):90. doi: 10.1186/s40814-024-01518-z.

  PMID: 38879518 DERIVED

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Justyna Bartoszko, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

• Jeannie Callum, MD

  Kingston Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Keyvan Karkouti, MD

CONTACT

416-340-4800; Keyvan.Karkouti@uhn.ca

Deep Grewal

CONTACT

416-340-4800; Deep.Grewal@uhn.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This will be a blinded randomized trial, with clinical personnel, patients, family members, and outcome assessors blinded to group allocation. Given that the platelets will be different temperatures (but identical in appearance), an unblinded blood bank technologist, who will not have access to the collected study data, will blind the platelets by placing them in an insulated tamper-proof container accompanied by a pair of disposable insulated gloves. The clinician(s) directly handling the product at the time of transfusion will wear the insulated gloves to prevent unblinding (simulations have shown this to be an effective strategy). The platelets will also have blinded study labels and come prepared in identical collection bags.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: PLTS-1 is a multicentre, randomized, controlled, pilot trial, using a conventional, parallel group, two-armed design at 2 cardiac surgery centres in Canada.

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 27, 2023
• Study Start: June 5, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)