drugset / Trial / NCT04726410

Cold-stored Platelet Early Intervention in TBI

NCT04726410 ↗

RandomizedParallel-groupSingle-blindTreatment

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).

Timeline

Start
2022-03-21
Primary completion
2024-05-13
Completion
2024-05-13

Drugs

EvaluationDrugModalityDoseRoute
Subject Cold Stored Platelets Unknown 2 unknown —