MedTrace Logo

Cold Stored Platelet in Hemorrhagic Shock

NCT04667468 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-12-18

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

BIOLOGICAL

Standard Care

standard care including blood and blood component therapy

BIOLOGICAL

Cold Stored Platelets (CSP)

early infusion of urgent release CSP

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Jason Sperry

    lead OTHER

Principal Investigators

  • Jason Sperry, MD, MPH · University of Pittsburgh

  • Frank Guyette, MD, MPH · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-21
Primary Completion
2023-10-07
Completion
2023-11-20
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04667468 on ClinicalTrials.gov