Cold-stored Platelet Transfusion for Traumatic Brain Injury (CriSP-TBI Trial)

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Jason Sperry

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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).

Eligibility Criteria

This trial is for adults with traumatic brain injury at risk of needing urgent neurosurgery, who may have used antiplatelet drugs before the injury or need a platelet transfusion. It's not for those under 18 or over 89, pregnant women, prisoners, people with penetrating injuries, hypotension in the ER, going to non-neurosurgical operations soon after arrival, or on certain anticoagulants.

Inclusion Criteria

I require platelet transfusions as per usual medical guidelines.

Exclusion Criteria

I am scheduled for a non-brain surgery within the first hour.

I am taking blood thinners along with aspirin or clopidogrel.

I am between 18 and 89 years old.

Treatment Details

The CriSP-TBI trial tests if giving cold stored platelets (CSP) quickly after a traumatic brain injury is feasible and safe compared to standard care. About 100 patients will be randomly chosen to receive either CSP early on or just the usual treatment without CSP.

2Treatment groups

Experimental Treatment

Active Control

Group I: Cold-stored Platelet (CSP)Experimental Treatment1 Intervention

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

Group II: Standard careActive Control1 Intervention

standard care therapy

Cold Stored Platelets is already approved in United States for the following indications:

🇺🇸 Approved in United States as Cold Stored Platelets for: