Status:
COMPLETED
Cold-stored Platelet Early Intervention in TBI
Lead Sponsor:
Jason Sperry
Collaborating Sponsors:
United States Department of Defense
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18-89 years
Phase:
PHASE2
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, efficac...
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 outcom...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 13 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04726410
Start Date
March 21 2022
End Date
May 13 2024
Last Update
May 11 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213