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Active, Not Recruiting

NCT Number: NCT06147531

Delayed Cold-Stored Platelets -PLTS-1

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Platelets Bleeding Cardiac Surgery Cardiopulmonary Bypass Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kingston Health Sciences Centre, Kingston, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • 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.

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:

  • 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).

Treatment and study plan

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).

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.

Primary outcomes

  1. Feasibility Outcome 1: Adequate Patient Recruitment

    Time frame: 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).

  2. Feasibility Outcome 2: Adequate cold-stored platelet supply

    Time frame: 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).

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

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Canadian Blood Services
  • Kingston Health Sciences Centre

Registry information

Official study title

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)

Acronym: PLTS-1

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 27, 2023
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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