Adults 18 to 89, any sex, with Traumatic Brain Injury. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Study FeasibilityPrimary· 6 months
proportion of eligible patients that can be randomized, enrolled, adhere to protocol, and complete follow-up
Group
Value
95% CI
Cold-stored Platelet (CSP)
50
Standard Care
50
6-month Extended Glasgow Outcome Scale (GOS-E)Secondary· 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).
Group
Value
95% CI
Cold-stored Platelet (CSP)
21
Standard Care
20
Cold-stored Platelet (CSP)
22
Standard Care
20
24-hour MortalitySecondary· Enrollment through 24 hours
Mortality within 24 hours
Group
Value
95% CI
Cold-stored Platelet (CSP)
1
Standard Care
0
In-hospital MortalitySecondary· Enrollment through discharge up to 6 months
Mortality in-hospital
Group
Value
95% CI
Cold-stored Platelet (CSP)
6
Standard Care
7
TBI ProgressionSecondary· Enrollment through 24 hours
Evidence of progression of TBI. Common Data Elements for CT scan indicators of TBI progression will be utilized.
Group
Value
95% CI
Cold-stored Platelet (CSP)
8
Standard Care
11
Galveston Orientation and Amnesia Test (GOAT)Secondary· 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 "
Group
Value
95% CI
Cold-stored Platelet (CSP)
95
72 – 100
Standard Care
91
71 – 100
Incidence of Allergic/Transfusion ReactionSecondary· Enrollment through 24 hours
Any transfusion complication in Emergency Department or Operating Room
Group
Value
95% CI
Cold-stored Platelet (CSP)
0
Standard Care
0
Incidence of Transfusion Related Acute Lung Injury (TRALI)Secondary· Enrollment through 48 hours
Occurrence of Acute Respiratory Distress Syndrome (ARDS) within 6 hours of transfusion of platelets
Group
Value
95% CI
Cold-stored Platelet (CSP)
0
Standard Care
0
Incidence of Thromboembolic EventsSecondary· Enrollment through 48 hours
Incidence of pulmonary embolism, venous thrombosis, or arterial thrombosis
Group
Value
95% CI
Cold-stored Platelet (CSP)
1
Standard Care
0
Adverse events — posted to ClinicalTrials.gov
Time frame: 6 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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).
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Jason Sperry
Last refreshed: 11 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04726410.