Cold-stored Platelet Early Intervention in TBI

Traumatic Brain Injury Clinical Trial

— CriSP-TBI  

Official title:

Cold Stored Platelet Early Intervention in Traumatic Brain Injury Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04726410
• Other study ID #: STUDY20070044
• Secondary ID: W81XWH-16-D-0024
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 21, 2022
• Est. completion date: June 2024

Study information

• Verified date: May 2024
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: June 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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)

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury

Intervention

Biological:
• Cold Stored Platelets
early infusion of urgent release CSP
• Standard Care
standard care including room temperature platelets

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Jason Sperry	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study feasibility	proportion of eligible patients that can be randomized, enrolled, adhere to protocol, and complete follow-up	Enrollment through 6 months
Secondary	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
Secondary	24-hour mortality	Mortality within 24 hours	Enrollment through 24 hours
Secondary	In-hospital mortality	Mortality in-hospital	Enrollment through discharge up to 6 months
Secondary	TBI Progression	Evidence of progression of TBI. Common Data Elements for CT scan indicators of TBI progression will be utilized.	Enrollment through 24 hours
Secondary	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. A score of 66 or lower is categorized as "impaired," 66-75 as "borderline," and 76-100 as "normal."	Enrollment through discharge up to 6 months
Secondary	Incidence of allergic/transfusion reaction	Any transfusion complication in Emergency Department or Operating Room	Enrollment through 24 hours
Secondary	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
Secondary	rapid thrombelastography (rTEG) measurement of platelet hemostatic function	rTEG	Enrollment through 24 hours
Secondary	rTEG with platelet mapping	TEG-PM assessment of platelet function	Enrollment through 24 hours
Secondary	whole blood aggregometry test	test of platelet aggregation using low-dose collagen as a stimulus	Enrollment through 24 hours
Secondary	Incidence of thromboembolic events	Incidence of pulmonary embolism, venous thrombosis, or arterial thrombosis	Enrollment through 48 hours