Traumatic Brain InjuryPhase 2CriSP-TBINCT04726410
Cold-stored Platelet Early Intervention in TBI
A Phase 2 study testing Cold Stored Platelets in people with Traumatic Brain Injury, run by Jason Sperry at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Cold Stored Platelets
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2022to 13 May 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Wearing NO CriSP opt out bracelet
- Hypotension in Emergency Department (SBP< 90 mmHg)
- Age > 89 or < 18 years of age
- Penetrating injury
- Prisoner
- Pregnancy
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: 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).
Read the 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.
- Conditions
- Traumatic Brain Injury
- Being tested
- Cold Stored Platelets, Standard Care
- Keywords
- Traumatic Brain Injury, Cold Stored Platelets
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold Stored PlateletsBiological
early infusion of urgent release CSP
Standard CareBiological
standard care including room temperature platelets
| Study group | Role | What they receive |
|---|---|---|
| Cold-stored Platelet (CSP) | Experimental | early infusion of up to 2 units of urgent release cold stored platelets (CSP) Receives: Biological: Cold Stored Platelets |
| Standard care | Active comparator | standard care therapy Receives: Biological: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study Feasibility
proportion of eligible patients that can be randomized, enrolled, adhere to protocol, and complete follow-up
Measured: 6 months
Secondary outcomes (8)
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).
Measured: 6 months after enrollment
24-hour Mortality
Mortality within 24 hours
Measured: Enrollment through 24 hours
In-hospital Mortality
Mortality in-hospital
Measured: 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.
Measured: 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
Measured: At Discharge from Current Hospital Admission
Incidence of Allergic/Transfusion Reaction
Any transfusion complication in Emergency Department or Operating Room
Measured: 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
Measured: Enrollment through 48 hours
Incidence of Thromboembolic Events
Incidence of pulmonary embolism, venous thrombosis, or arterial thrombosis
Measured: Enrollment through 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start21 Mar 2022
- Primary completion13 May 2024
- Study completion13 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- permuted block design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jason Sperry
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor-investigator, Jason Sperry, University of Pittsburgh
- Investigators
- Jason L Sperry, MD, Study director, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04726410
- Sponsor's protocol ID
- STUDY20070044
- Other IDs
- W81XWH-16-D-0024
- Acronym
- CriSP-TBI
- Status last verified
- Apr 2025
- First submitted
- 12 Jan 2021
- Last updated
- 11 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Brunskill SJ, Disegna A, Wong H, Fabes J, Desborough MJ, Doree C, Davenport R, Curry N, Stanworth SJ. Blood transfusion strategies for major bleeding in trauma. Cochrane Database Syst Rev. 2025 Apr 24;4(4):CD012635. doi: 10.1002/14651858.CD012635.pub2.
PubMed 40271704
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cold Stored Platelet Early Intervention in Traumatic Brain Injury Trial
- ClinicalTrials.gov ID
- NCT04726410
- Acronym / sponsor ID
- CriSP-TBI / STUDY20070044
- Conditions
- Traumatic Brain Injury
- Keywords
- Traumatic Brain Injury, Cold Stored Platelets
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Jason SperryUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 13 May 2024 (actual)
- Study completion
- 13 May 2024 (actual)
- First posted
- 27 Jan 2021 (actual)
- Results
- Posted 29 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- permuted block design
| Arm | Type | Receives |
|---|---|---|
| Cold-stored Platelet (CSP) | Experimental | Biological: Cold Stored Plateletsearly infusion of up to 2 units of urgent release cold stored platelets (CSP) |
| Standard care | Active comparator | Biological: Standard Carestandard care therapy |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- Wearing NO CriSP opt out bracelet
- Hypotension in Emergency Department (SBP< 90 mmHg)
- Age > 89 or < 18 years of age
- Penetrating injury
- Prisoner
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cold Stored Plateletsearly infusion of urgent release CSP | Biological | Cold-stored Platelet (CSP) |
| Standard Carestandard care including room temperature platelets | Biological | Standard care |
Primary outcome
Study Feasibility
Time frame: 6 months
proportion of eligible patients that can be randomized, enrolled, adhere to protocol, and complete follow-up
8 secondary outcomes
6-month Extended Glasgow Outcome Scale (GOS-E)
Time frame: 6 months after enrollment
24-hour Mortality
Time frame: Enrollment through 24 hours
In-hospital Mortality
Time frame: Enrollment through discharge up to 6 months
TBI Progression
Time frame: Enrollment through 24 hours
Galveston Orientation and Amnesia Test (GOAT)
Time frame: At Discharge from Current Hospital Admission
Incidence of Allergic/Transfusion Reaction
Time frame: Enrollment through 24 hours
Incidence of Transfusion Related Acute Lung Injury (TRALI)
Time frame: Enrollment through 48 hours
Incidence of Thromboembolic Events
Time frame: Enrollment through 48 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40271704Brunskill SJ, Disegna A, Wong H, Fabes J, Desborough MJ, Doree C, Davenport R, Curry N, Stanworth SJ. Blood transfusion strategies for major bleeding in trauma. Cochrane Database Syst Rev. 2025 Apr 24;4(4):CD012635. doi: 10.1002/14651858.CD012635.pub2.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason L Sperry, MD study director
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cold Stored Platelets in people with Traumatic Brain Injury, run by Jason Sperry at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study Feasibility (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04726410, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025.