Cold-stored Platelet Early Intervention in TBI

NCT ID: NCT04726410

Last Updated: 2025-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-21
• Study Completion Date: 2024-05-13

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).

Detailed Description

Platelet transfusion is commonly provided to patients with moderate or severe TBI who are on antiplatelet medications. Evidence suggests that patients on antiplatelet medications may have worse outcomes following TBI. Current literature has not demonstrated major outcome improvements in those patients who receive platelet transfusion. This lack of significant benefit may be due to insufficient dosing or due to the poor hemostatic function of standard care room temperature platelets. Studying the potential benefits of Cold Stored Platelet transfusion in the TBI population will provide needed direct comparison of room temperature and cold stored platelet transfusion which is unable to occur in patients with hemorrhagic shock, who may require large volumes of red blood cells and plasma concomitantly with platelet transfusion.

By providing Cold Stored Platelets in an urgent release fashion following injury, a potentially superior hemostatic agent is given early, closer to the time of injury. The current pilot trial was designed to determine the feasibility, efficacy and safety of urgent release cold stored platelets as compared to standard care in TBI patients requiring platelet transfusion. There are no high-level data which appropriately characterize the urgent release use of cold stored platelets out to 14 days or their function over that time period as compared to standard room temperature platelets. These results will be able to inform future large randomized clinical trials allowing the most appropriate injured population, inclusion criteria, and primary outcome to be selected and utilized.

Conditions

Traumatic Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cold-stored Platelet (CSP)

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

Group Type: EXPERIMENTAL

Cold Stored Platelets

Intervention Type: BIOLOGICAL

early infusion of urgent release CSP

Standard care

standard care therapy

Group Type: ACTIVE_COMPARATOR

Standard Care

Intervention Type: BIOLOGICAL

standard care including room temperature platelets

Interventions

Cold Stored Platelets

early infusion of urgent release CSP

Intervention Type: BIOLOGICAL

Standard Care

standard care including room temperature platelets

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

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:

1. History or indication of pre-injury antiplatelet agent use

2. Need for platelet transfusion per standard practice

Exclusion Criteria

1. Wearing NO CriSP opt out bracelet

2. Hypotension in Emergency Department (SBP< 90 mmHg)

3. Age > 89 or < 18 years of age

4. Penetrating injury

5. Prisoner

6. Pregnancy

7. Going to operating room for non-neurosurgical intervention in first 60 minutes

8. Platelet transfusion contraindications per care team (for example, recent vascular stent, embolic stroke, intracranial and/or vascular lesions)

9. Objection to study voiced by participant or family member in Emergency Department

10. Currently on therapeutic anticoagulant in addition to aspirin and/or clopidogrel (e.g. warfarin, direct-acting oral anticoagulants)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Jason Sperry

OTHER

Sponsor Role: lead

Responsible Party

Jason Sperry

Professor of Surgery and Critical Care Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jason L Sperry, MD

Role: STUDY_DIRECTOR

University of Pittsburgh

Locations

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 40271704 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

W81XWH-16-D-0024

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STUDY20070044

Identifier Type: -

Identifier Source: org_study_id