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Delayed Cold-Stored Platelets -PLTS-1

NCT ID: NCT06147531

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-05

Study Completion Date

2026-12-31

Brief Summary

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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

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Conditions

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Platelets Bleeding Cardiopulmonary Bypass Cardiac Surgery

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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.

Study Groups

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Intervention Group

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.

Group Type EXPERIMENTAL

Delayed Cold-Stored Buffy Coat Platelets

Intervention Type 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).

Control Group

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).

Group Type ACTIVE_COMPARATOR

Room Temperature Buffy Coat Platelets

Intervention Type 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.

Interventions

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Delayed Cold-Stored Buffy Coat Platelets

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 Type BIOLOGICAL

Room Temperature Buffy Coat Platelets

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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kingston Health Sciences Centre

OTHER

Sponsor Role collaborator

Canadian Blood Services

OTHER

Sponsor Role collaborator

University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Justyna Bartoszko, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Jeannie Callum, MD

Role: PRINCIPAL_INVESTIGATOR

Kingston Health Sciences Centre

Locations

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Kingston Health Sciences Centre

Kingston, Ontario, Canada

Site Status RECRUITING

Toronto General Hospital - University Health Network

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Keyvan Karkouti, MD

Role: CONTACT

Phone: 416-340-4800

Email: [email protected]

Deep Grewal

Role: CONTACT

Phone: 416-340-4800

Email: [email protected]

Facility Contacts

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Jeannie Callum, MD

Role: primary

Justyna Bartoszko, MD MSc FRCPC

Role: primary

References

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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.

Reference Type DERIVED
PMID: 38879518 (View on PubMed)

Other Identifiers

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22-5855

Identifier Type: -

Identifier Source: org_study_id