Delayed Cold-Stored Platelets -PLTS-1

PHASE2RecruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

June 5, 2024

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2026

Conditions
PlateletsBleedingCardiopulmonary BypassCardiac Surgery
Interventions
BIOLOGICAL

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).

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.

Trial Locations (2)

K7L 2V7

RECRUITING

Kingston Health Sciences Centre, Kingston

M5G 2C4

RECRUITING

Toronto General Hospital - University Health Network, Toronto

All Listed Sponsors
collaborator

Queen's University

OTHER

collaborator

Canadian Blood Services

OTHER

lead

University Health Network, Toronto

OTHER