CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 100 enrolled
Drug / intervention
Cold Stored Platelets +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/NCT04726410
NCT04726410Phase 2Completed

Cold Stored Platelet Early Intervention in Traumatic Brain Injury Trial

Jason Sperry·interventional·Posted Jan 27, 2021·Updated May 11, 2025

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedJan 27, 2021
Enrollment StartMar 21, 2022
Primary CompletionMay 13, 2024
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 5.4 years ago

Interventions

Cold Stored Plateletsbiological

early infusion of urgent release CSP

Standard Carebiological

standard care including room temperature platelets