Trauma Clinical Trial
— CriSP-HSOfficial title:
Cold Stored Platelet Early Intervention in Hemorrhagic Shock (CriSP-HS) Trial
Verified date | June 2024 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The Cold Stored Platelet Early Intervention in Hemorrhagic Shock (CriSP-HS) trial is a proposed 3 year, open label, multi-center, randomized trial designed to determine the feasibility, efficacy, and safety of urgent release cold stored platelets (CSP) in patients in hemorrhagic shock. Patients will be randomized to receive either standard care or early infusion of urgent release cold stored platelets (CSP). The proposed pilot study will utilize 5 level-1 trauma centers from within the LITES network and will enroll approximately 200 patients. The primary outcome for the pilot trial is feasibility, with principal secondary clinical outcome of 24 hour mortality.
Status | Completed |
Enrollment | 200 |
Est. completion date | November 20, 2023 |
Est. primary completion date | October 7, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 15 Years to 90 Years |
Eligibility | Inclusion Criteria: Patients with traumatic injury who meet the following criteria: 1. Has 2 or more of any of the following: 1. Hypotension (systolic blood pressure = 90 mmHg) in the prehospital or emergency department setting 2. Penetrating mechanism 3. Abdominal or Extended Focused Assessment with Sonography for Trauma (FAST) abdominal ultrasound is positive or equivocal or deferred by clinical team due to emergent visit to Interventional Radiology or a need for emergent laparotomy, thoracotomy, or vascular exploration 4. Heart rate = 120 in the prehospital or emergency department setting AND 2. Clinical team deems Operating Room (laparotomy, thoracotomy or vascular exploration) or Interventional Radiology for embolization within 60 minutes of arrival to be clinically indicated. Exclusion Criteria: 1. Wearing "NO CriSP" opt-out bracelet 2. Age >90 or <15 years of age 3. Isolated fall from standing injury mechanism 4. Prisoner 5. Pregnant 6. Traumatic arrest with >5 minutes of CPR without return of vital signs 7. Brain matter exposed or penetrating brain injury (gun shot wound [GSW]) 8. Isolated drowning or hanging victims 9. Isolated burns > estimated 20% total body surface area 10. Objection to study voiced by subject or family member in Emergency Department Inclusion and exclusion criteria will be assessed based on information available at the time of enrollment. If, after subsequent review, it is determined that the subject did not meet inclusion criteria and/or met exclusion criteria, the subject will remain enrolled in the study based on the intent-to-treat principle. If a verbal report must be used in lieu of physical documentation or directly witnessing inclusion criteria, documentation of the verbal report will serve as the source documentation for determining eligibility. |
Country | Name | City | State |
---|---|---|---|
United States | Baylor College of Medicine | Houston | Texas |
United States | University of Texas Health Sciences Center Houston | Houston | Texas |
United States | University of Mississippi | Jackson | Mississippi |
United States | University of Southern California | Los Angeles | California |
United States | University of California San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
Jason Sperry | United States Department of Defense |
United States,
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 30 days or discharge | |
Secondary | 24-hour mortality | Mortality within 24 hours | Enrollment through 24 hours | |
Secondary | 3-hour mortality | Mortality within 3 hours | Enrollment through 3 hours | |
Secondary | In hospital mortality | mortality in-hospital | Enrollment through 30 days or discharge | |
Secondary | Death from hemorrhage | mortality due to hemorrhage | Enrollment through 24 hours | |
Secondary | Blood or blood component type required for transfusion | Type of blood and/or blood components required to be transfused | Enrollment through 24 hours | |
Secondary | Amount of blood or blood component required for transfusion | number of units of blood and/or blood components required to be transfused | Enrollment through 24 hours | |
Secondary | Incidence of acute respiratory distress syndrome (ARDS) | Berlin definition of mild ARDS will determine incidence and will be further stratified into Moderate and Severe | Enrollment through 48 hours | |
Secondary | Time to hemostasis | Amount of time from randomization to point of nadir transfusion requirement of 1 unit of red blood cells in a 60-minute time period | Enrollment through 4 hours | |
Secondary | Incidence of coagulopathy by rapid thrombelastography (rTEG) | Coagulopathy as indicated by rTEG measures | Enrollment through 48 hours | |
Secondary | Incidence of allergic/transfusion reaction | Any transfusion complication in Emergency Department or Operating Room/Interventional Radiology | Enrollment through 24 hours | |
Secondary | Incidence of transfusion related acute lung injury (TRALI) | Occurrence of ARDS within 6 hours of transfusion of blood product | Enrollment through 48 hours | |
Secondary | rTEG measurement of platelet hemostatic function | rTEG | 60 minutes and 24 hours after arrival | |
Secondary | Prothrombin Time (PT) measurement of platelet hemostatic function | PT | 60 minutes and 24 hours after arrival | |
Secondary | International Normalized Ratio (INR) measurement of platelet hemostatic function | INR | 60 minutes and 24 hours after arrival | |
Secondary | Incidence of thromboembolic events | Incidence of pulmonary embolism, venous thrombosis, or arterial thrombosis | Enrollment through 48 hours | |
Secondary | 30-day mortality | mortality within 30 days | Enrollment through 30 days |
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