drugset / Trial / NCT04667468

Cold Stored Platelet in Hemorrhagic Shock

NCT04667468 ↗

RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2022-06-21
Primary completion
2023-10-07
Completion
2023-11-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Cold Stored Platelets Unknown — Other

Indications