At a glance
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Cold Stored Platelet Early Intervention in Hemorrhagic Shock (CriSP-HS) Trial
In Brief
A Phase 2 clinical trial evaluating Cold Stored Platelets (CSP) and Standard Care for Trauma and Hemorrhage. Completed, enrolled 200 participants across 5 sites.
Detailed Summary
The Cold Stored Platelet Early Intervention in Hemorrhagic Shock (CriSP-HS) trial is a proposed 3 year, open label, multi-center, randomized trial designed to determine the feasibility, efficacy, and safety of urgent release cold stored platelets (CSP) in patients in hemorrhagic shock. Patients will be randomized to receive either standard care or early infusion of urgent release cold stored platelets (CSP). The proposed pilot study will utilize 5 level-1 trauma centers from within the LITES network and will enroll approximately 200 patients. The primary outcome for the pilot trial is feasibility, with principal secondary clinical outcome of 24 hour mortality.
Study Details
Timeline
Interventions
early infusion of urgent release CSP
standard care including blood and blood component therapy