Status:
COMPLETED
Cold Stored Platelet in Hemorrhagic Shock
Lead Sponsor:
Jason Sperry
Collaborating Sponsors:
United States Department of Defense
Conditions:
Trauma
Hemorrhage
Eligibility:
All Genders
15-90 years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
The acute management of the severely injured patient with hemorrhage following trauma center arrival has evolved over the last decade. Current treatment priorities include prevention of coagulopathy ...
Eligibility Criteria
Inclusion
- Patients with traumatic injury who meet the following criteria:
- Has 2 or more of any of the following:
- Hypotension (systolic blood pressure ≤ 90 mmHg) in the prehospital or emergency department setting
- Penetrating mechanism
- 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
- Heart rate ≥ 120 in the prehospital or emergency department setting
- AND
- 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
- Wearing "NO CriSP" opt-out bracelet
- Age \>90 or \<15 years of age
- Isolated fall from standing injury mechanism
- Prisoner
- Pregnant
- Traumatic arrest with \>5 minutes of CPR without return of vital signs
- Brain matter exposed or penetrating brain injury (gun shot wound \[GSW\])
- Isolated drowning or hanging victims
- Isolated burns \> estimated 20% total body surface area
- 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.
Key Trial Info
Start Date :
June 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 20 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04667468
Start Date
June 21 2022
End Date
November 20 2023
Last Update
December 18 2024
Active Locations (5)
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1
University of Southern California
Los Angeles, California, United States, 90033
2
University of California San Francisco
San Francisco, California, United States, 94110
3
University of Mississippi
Jackson, Mississippi, United States, 39216
4
Baylor College of Medicine
Houston, Texas, United States, 77030