drugset / Trial / NCT04667468
Cold Stored Platelet in Hemorrhagic Shock
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cold Stored Platelets | Unknown | — | Other |