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.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Feasibility Outcome 1: Adequate Patient Recruitment
Timeframe: through study completion, an average of 1 year.
Feasibility Outcome 2: Adequate cold-stored platelet supply
Timeframe: through study completion, an average of 1 year.
Feasibility Outcome 3: Adequate clinician adherence to randomization assignment.
Timeframe: through study completion, an average of 1 year.