A Phase 2 interventional study of Cold Stored Platelets and Standard Care in Traumatic Brain Injury, sponsored by Jason Sperry. Completed at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2025-05-11.
Sponsored by Jason Sperry · Phase 2, Interventional, and Treatment
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).
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.
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:
Exclusion Criteria:
early infusion of up to 2 units of urgent release cold stored platelets (CSP)
Biological: Cold Stored Platelets
standard care therapy
Biological: Standard Care
early infusion of urgent release CSP
standard care including room temperature platelets
Study Feasibility
proportion of eligible patients that can be randomized, enrolled, adhere to protocol, and complete follow-up
Time frame: 6 months
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).
Time frame: 6 months after enrollment
24-hour Mortality
Mortality within 24 hours
Time frame: Enrollment through 24 hours
In-hospital Mortality
Mortality in-hospital
Time frame: Enrollment through discharge up to 6 months
TBI Progression
Evidence of progression of TBI. Common Data Elements for CT scan indicators of TBI progression will be utilized.
Time frame: Enrollment through 24 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
Time frame: At Discharge from Current Hospital Admission
Incidence of Allergic/Transfusion Reaction
Any transfusion complication in Emergency Department or Operating Room
Time frame: 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
Time frame: Enrollment through 48 hours
Incidence of Thromboembolic Events
Incidence of pulmonary embolism, venous thrombosis, or arterial thrombosis
Time frame: Enrollment through 48 hours
| Milestone | Cold-stored Platelet (CSP) | Standard Care |
|---|---|---|
| Started | 50 | 50 |
| Completed | 50 | 49 |
| Not completed | 0 | 1 |
proportion of eligible patients that can be randomized, enrolled, adhere to protocol, and complete follow-up
| Participants | Cold-stored Platelet (CSP) | Standard Care |
|---|---|---|
| Study Feasibility | 50 | 50 |
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).
| Participants | Cold-stored Platelet (CSP) | Standard Care |
|---|---|---|
| Unfavorable | 21 | 20 |
| Favorable | 22 | 20 |
Mortality within 24 hours
| Participants | Cold-stored Platelet (CSP) | Standard Care |
|---|---|---|
| 24-hour Mortality | 1 | 0 |
Mortality in-hospital
| Participants | Cold-stored Platelet (CSP) | Standard Care |
|---|---|---|
| In-hospital Mortality | 6 | 7 |
Evidence of progression of TBI. Common Data Elements for CT scan indicators of TBI progression will be utilized.
| Participants | Cold-stored Platelet (CSP) | Standard Care |
|---|---|---|
| TBI Progression | 8 | 11 |
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
| score on a scale | Cold-stored Platelet (CSP) | Standard Care |
|---|---|---|
| Galveston Orientation and Amnesia Test (GOAT) | 95 (72 to 100) | 91 (71 to 100) |
Any transfusion complication in Emergency Department or Operating Room
| Participants | Cold-stored Platelet (CSP) | Standard Care |
|---|---|---|
| Incidence of Allergic/Transfusion Reaction | 0 | 0 |
Occurrence of Acute Respiratory Distress Syndrome (ARDS) within 6 hours of transfusion of platelets
| Participants | Cold-stored Platelet (CSP) | Standard Care |
|---|---|---|
| Incidence of Transfusion Related Acute Lung Injury (TRALI) | 0 | 0 |
Incidence of pulmonary embolism, venous thrombosis, or arterial thrombosis
| Participants | Cold-stored Platelet (CSP) | Standard Care |
|---|---|---|
| Incidence of Thromboembolic Events | 1 | 0 |
Collected over 6 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cold-stored Platelet (CSP) | 6/50 (12%) | 9/50 (18%) | 0/50 (0%) |
| Standard Care | 7/49 (14.3%) | 8/49 (16.3%) | 0/49 (0%) |
| Event | Cold-stored Platelet (CSP) | Standard Care |
|---|---|---|
| otherInfections and infestations | 2/50 | 4/49 |
| PneumoniaRespiratory, thoracic and mediastinal disorders | 3/50 | 2/49 |
| Acute kidney injuryRenal and urinary disorders | 2/50 | 1/49 |
| seizuresNervous system disorders | 0/50 | 1/49 |
| pulmonary consolidationRespiratory, thoracic and mediastinal disorders | 1/50 | 0/49 |
| deep vein thrombosisVascular disorders | 1/50 | 0/49 |
| Age, Continuous(years) | Cold-stored Platelet (CSP) | Standard Care | Total |
|---|---|---|---|
| Median | 73.5 (67 to 80) | 78 (66 to 82) | 76 (66 to 81) |
| Sex: Female, Male(Participants) | Cold-stored Platelet (CSP) | Standard Care | Total |
|---|---|---|---|
| Female | 23 | 24 | 47 |
| Male | 27 | 26 | 53 |
| Race (NIH/OMB)(Participants) | Cold-stored Platelet (CSP) | Standard Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 4 | 5 | 9 |
| White | 44 | 37 | 81 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 7 | 9 |
| Region of Enrollment(Participants) | Cold-stored Platelet (CSP) | Standard Care | Total |
|---|---|---|---|
| United States | 50 | 50 | 100 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — 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.
Supporting information: Study protocol, Icf
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Jason Sperry