Cold-stored Platelet Early Intervention in TBI

Phase 2

Completed

Conditions: Traumatic Brain Injury

Interventions: Biological: Cold Stored Platelets
Biological: Standard Care

Registration Number: NCT04726410

Lead Sponsor: Jason Sperry

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 100

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
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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cold-stored Platelet (CSP)	Cold Stored Platelets	early infusion of up to 2 units of urgent release cold stored platelets (CSP)
Standard care	Standard Care	standard care therapy

Primary Outcome Measures

Name	Time	Method
Study Feasibility	6 months	proportion of eligible patients that can be randomized, enrolled, adhere to protocol, and complete follow-up

Secondary Outcome Measures

Name	Time	Method
24-hour Mortality	Enrollment through 24 hours	Mortality within 24 hours
In-hospital Mortality	Enrollment through discharge up to 6 months	Mortality in-hospital
Incidence of Allergic/Transfusion Reaction	Enrollment through 24 hours	Any transfusion complication in Emergency Department or Operating Room
6-month Extended Glasgow Outcome Scale (GOS-E)	6 months after enrollment	A tool used to characterize 6-month functional status into 8 defined categories, with 1 being the worst (death) to 8 being the most favorable (good recovery).
TBI Progression	Enrollment through 24 hours	Evidence of progression of TBI. Common Data Elements for CT scan indicators of TBI progression will be utilized.
Galveston Orientation and Amnesia Test (GOAT)	At Discharge from Current Hospital Admission	10-item questionnaire used to quickly assess post-traumatic amnesia following head injury. The GOAT is read orally to the patient and may be easily administered at the bedside. The total score accounts for orientation of person, place, and time, and recollection of events pre and post- injury. Cutoff scores are available to identify abnormal, borderline, and normal orientation. The total GOAT score is obtained by deducting the sum of the error points from each incorrect response from 100.Range is 0-100. A score of 66 or lower is categorized as "impaired," 66-75 as "borderline," and 76-100 as "normal." This will be obtained At Discharge from Current Hospital Admission
Incidence of Transfusion Related Acute Lung Injury (TRALI)	Enrollment through 48 hours	Occurrence of Acute Respiratory Distress Syndrome (ARDS) within 6 hours of transfusion of platelets
Incidence of Thromboembolic Events	Enrollment through 48 hours	Incidence of pulmonary embolism, venous thrombosis, or arterial thrombosis