CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 200 enrolled
Drug / intervention
Cold Stored Platelets (CSP) +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04667468
NCT04667468Phase 2Completed

Cold Stored Platelet Early Intervention in Hemorrhagic Shock (CriSP-HS) Trial

Jason Sperry·interventional·Posted Dec 14, 2020·Updated Dec 18, 2024

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTrauma, Hemorrhage
CountriesUnited States

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedDec 14, 2020
Enrollment StartJun 21, 2022
Primary CompletionOct 7, 2023
Study CompletionNov 20, 2023
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 5.5 years ago

Interventions

Cold Stored Platelets (CSP)biological

early infusion of urgent release CSP

Standard Carebiological

standard care including blood and blood component therapy