Cold Stored Platelet Early Intervention in Traumatic Brain Injury Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Jason Sperry
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Study Feasibility
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 89 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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< 90 mmHg)
- •Age > 89 or < 18 years of age
- •Penetrating injury
- •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)
Arms & Interventions
Cold-stored Platelet (CSP)
early infusion of up to 2 units of urgent release cold stored platelets (CSP)
Intervention: Cold Stored Platelets (Biological)
Standard care
standard care therapy
Intervention: Standard Care (Biological)
Outcomes
Primary Outcomes
Study Feasibility
Time Frame: 6 months
proportion of eligible patients that can be randomized, enrolled, adhere to protocol, and complete follow-up
Secondary Outcomes
- 24-hour Mortality(Enrollment through 24 hours)
- In-hospital Mortality(Enrollment through discharge up to 6 months)
- Incidence of Allergic/Transfusion Reaction(Enrollment through 24 hours)
- 6-month Extended Glasgow Outcome Scale (GOS-E)(6 months after enrollment)
- TBI Progression(Enrollment through 24 hours)
- Galveston Orientation and Amnesia Test (GOAT)(At Discharge from Current Hospital Admission)
- Incidence of Transfusion Related Acute Lung Injury (TRALI)(Enrollment through 48 hours)
- Incidence of Thromboembolic Events(Enrollment through 48 hours)
Investigators
Jason Sperry
Professor of Surgery and Critical Care Medicine
University of Pittsburgh