Clinical trial NCT04726410: Cold-stored Platelet Early Intervention in TBI
Official title: Cold Stored Platelet Early Intervention in Traumatic Brain Injury Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Traumatic Brain Injury
Keywords: Traumatic Brain Injury
Cold Stored Platelets
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2021-01-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: permuted block design
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Study Feasibility
timeFrame: 6 months
Secondary outcomes:
measure: 6-month Extended Glasgow Outcome Scale (GOS-E)
timeFrame: 6 months after enrollment
measure: 24-hour Mortality
timeFrame: Enrollment through 24 hours
measure: In-hospital Mortality
timeFrame: Enrollment through discharge up to 6 months
measure: TBI Progression
timeFrame: Enrollment through 24 hours
measure: Galveston Orientation and Amnesia Test (GOAT)
timeFrame: At Discharge from Current Hospital Admission
measure: Incidence of Allergic/Transfusion Reaction
timeFrame: Enrollment through 24 hours
measure: Incidence of Transfusion Related Acute Lung Injury (TRALI)
timeFrame: Enrollment through 48 hours
measure: Incidence of Thromboembolic Events
timeFrame: Enrollment through 48 hours
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Jason L Sperry, MD
role: STUDY_DIRECTOR
References: