Cold-stored Platelet Early Intervention in TBI

NCT04726410 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: STUDY20070044W81XWH-16-D-0024
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Traumatic Brain Injury

Keywords

Traumatic Brain Injury; Cold Stored Platelets

Outcome Measures

Primary Outcomes (1)

• Study Feasibility

  proportion of eligible patients that can be randomized, enrolled, adhere to protocol, and complete follow-up

  6 months

Secondary Outcomes (8)

• 6-month Extended Glasgow Outcome Scale (GOS-E)

  6 months after enrollment

• 24-hour Mortality

  Enrollment through 24 hours

• In-hospital Mortality

  Enrollment through discharge up to 6 months

• TBI Progression

  Enrollment through 24 hours

• Galveston Orientation and Amnesia Test (GOAT)

  At Discharge from Current Hospital Admission

Study Arms (2)

Cold-stored Platelet (CSP)

EXPERIMENTAL

early infusion of up to 2 units of urgent release cold stored platelets (CSP)

Biological: Cold Stored Platelets

Standard care

ACTIVE COMPARATOR

standard care therapy

Biological: Standard Care

Interventions

Cold Stored Platelets BIOLOGICAL

early infusion of urgent release CSP

Cold-stored Platelet (CSP)

Standard Care BIOLOGICAL

standard care including room temperature platelets

Standard care

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with traumatic brain injury, defined by presence of potential progressive intracranial injury on CT scan, at significant risk for urgent neurosurgical procedure as determined by neurosurgical evaluation, who meet at least one of the following:
• History or indication of pre-injury antiplatelet agent use
• Need for platelet transfusion per standard practice

You may not qualify if:

• Wearing NO CriSP opt out bracelet
• Hypotension in Emergency Department (SBP\< 90 mmHg)
• Age \> 89 or \< 18 years of age
• Penetrating injury
• Prisoner
• Pregnancy
• Going to operating room for non-neurosurgical intervention in first 60 minutes
• Platelet transfusion contraindications per care team (for example, recent vascular stent, embolic stroke, intracranial and/or vascular lesions)
• Objection to study voiced by participant or family member in Emergency Department
• Currently on therapeutic anticoagulant in addition to aspirin and/or clopidogrel (e.g. warfarin, direct-acting oral anticoagulants)

Sponsors & Collaborators

• Jason Sperry: lead
• United States Department of Defense: collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• Brunskill SJ, Disegna A, Wong H, Fabes J, Desborough MJ, Doree C, Davenport R, Curry N, Stanworth SJ. Blood transfusion strategies for major bleeding in trauma. Cochrane Database Syst Rev. 2025 Apr 24;4(4):CD012635. doi: 10.1002/14651858.CD012635.pub2.

  PMID: 40271704 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Jason Sperry
• Organization: University of Pittsburgh

sperryjl@upmc.edu

4128028270

Study Officials

• Jason L Sperry, MD

  University of Pittsburgh

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Surgery and Critical Care Medicine

Model Details: permuted block design

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: January 27, 2021
• Study Start: March 21, 2022
• Primary Completion: May 13, 2024
• Study Completion: May 13, 2024
• Last Updated: May 11, 2025
• Results First Posted: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will become available after publication of the primary manuscript
• Access Criteria: Requests for data will be submitted in writing and reviewed by the IND Sponsor and Principal Investigator

Locations

US (1)