At a glance
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Cold Stored Platelet Early Intervention in Traumatic Brain Injury Trial
In Brief
A Phase 2 clinical trial evaluating Cold Stored Platelets and Standard Care for Traumatic Brain Injury. Completed, enrolled 100 participants across 1 site.
Detailed Summary
The Cold Stored Platelet Early Intervention in Traumatic Brain Injury (CriSP-TBI) trial is a proposed 3 year, open label, single center, randomized trial designed to determine the feasibility, efficacy, and safety of urgent release cold stored platelets (CSP) in patients with TBI requiring platelet transfusion. Patients will be randomized to receive either standard care or early infusion of urgent release cold stored platelets (CSP). The proposed pilot study will enroll at the University of Pittsburgh and will enroll approximately 100 patients. The primary outcome for the pilot trial is feasibility, with principal secondary clinical outcome of 6-month Extended Glasgow Outcome Scale (GOS-E).
Study Details
Timeline
Interventions
early infusion of urgent release CSP
standard care including room temperature platelets