Cold-stored Platelet Early Intervention in TBI (CriSP-TBI)

Cold Stored Platelet Early Intervention in Traumatic Brain Injury Trial

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).

Study Overview

• Status: Completed
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Biological: Cold Stored Platelets; Biological: Standard Care

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cold-stored Platelet (CSP); early infusion of up to 2 units of urgent release cold stored platelets (CSP)	Biological: Cold Stored Platelets; early infusion of urgent release CSP
Active Comparator: Standard care; standard care therapy	Biological: Standard Care; standard care including room temperature platelets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study Feasibility	proportion of eligible patients that can be randomized, enrolled, adhere to protocol, and complete follow-up	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-month Extended Glasgow Outcome Scale (GOS-E)	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).	6 months after enrollment
TBI Progression	Evidence of progression of TBI. Common Data Elements for CT scan indicators of TBI progression will be utilized.	Enrollment through 24 hours
24-hour Mortality	Mortality within 24 hours	Enrollment through 24 hours
Incidence of Thromboembolic Events	Incidence of pulmonary embolism, venous thrombosis, or arterial thrombosis	Enrollment through 48 hours
In-hospital Mortality	Mortality in-hospital	Enrollment through discharge up to 6 months
Incidence of Allergic/Transfusion Reaction	Any transfusion complication in Emergency Department or Operating Room	Enrollment through 24 hours
Incidence of Transfusion Related Acute Lung Injury (TRALI)	Occurrence of Acute Respiratory Distress Syndrome (ARDS) within 6 hours of transfusion of platelets	Enrollment through 48 hours
Galveston Orientation and Amnesia Test (GOAT)	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	At Discharge from Current Hospital Admission

Collaborators and Investigators

• Sponsor: Jason Sperry
• Collaborators: United States Department of Defense
• Investigators: Study Director: Jason L Sperry, MD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2022
• Primary Completion (Actual): May 13, 2024
• Study Completion (Actual): May 13, 2024

Study Registration Dates

• First Submitted: January 12, 2021
• First Submitted That Met QC Criteria: January 26, 2021
• First Posted (Actual): January 27, 2021

Study Record Updates

• Last Update Posted (Actual): May 11, 2025
• Last Update Submitted That Met QC Criteria: April 28, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Traumatic Brain Injury; Cold Stored Platelets
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries, Traumatic; Brain Injuries
• Other Study ID Numbers: STUDY20070044; W81XWH-16-D-0024 (Other Grant/Funding Number: Department of Defense)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data may be shared with the funding agency as well as other researchers upon request to the Investigational New Drug (IND) Sponsor and Principal Investigator.
• IPD Sharing Time Frame: Data will become available after publication of the primary manuscript
• IPD Sharing Access Criteria: Requests for data will be submitted in writing and reviewed by the IND Sponsor and Principal Investigator
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No