Phase 2
N=100
Cold-stored Platelet Early Intervention in TBI
Traumatic Brain Injury
Bottom Line
View on ClinicalTrials.gov: NCT04726410 ↗Enrolled (actual)
100
Serious AEs
17.2%
Results posted
Apr 2025
Primary outcome: Primary: Study Feasibility — 50; 50 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cold Stored Platelets (Biological); Standard Care (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Jason Sperry
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Study Feasibility |
50; 50 | — |
| SECONDARY 6-month Extended Glasgow Outcome Scale (GOS-E) |
21; 20; 22; 20 | — |
| SECONDARY 24-hour Mortality |
1; 0 | — |
| SECONDARY In-hospital Mortality |
6; 7 | — |
| SECONDARY TBI Progression |
8; 11 | — |
| SECONDARY Galveston Orientation and Amnesia Test (GOAT) |
95; 91 | — |
| SECONDARY Incidence of Allergic/Transfusion Reaction |
0; 0 | — |
| SECONDARY Incidence of Transfusion Related Acute Lung Injury (TRALI) |
0; 0 | — |
| SECONDARY Incidence of Thromboembolic Events |
1; 0 | — |
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).
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:
- History or indication of pre-injury antiplatelet agent use
- Need for platelet transfusion per standard practice
Exclusion Criteria
- Wearing NO CriSP opt out bracelet
- Hypotension in Emergency Department (SBP 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)
Data sourced from ClinicalTrials.gov (NCT04726410). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.