Cold Stored Platelet in Hemorrhagic Shock (CriSP-HS)
Trauma, Hemorrhage
About this trial
This is an interventional treatment trial for Trauma focused on measuring platelet, hemorrhagic shock, trauma
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
- 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.
Sites / Locations
- University of Southern California
- University of California San Francisco
- University of Mississippi
- Baylor College of Medicine
- University of Texas Health Sciences Center Houston
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Cold-stored Platelet (CSP)
Standard Care
early infusion of one apheresis unit urgent release cold stored platelets (CSP)
resuscitation, blood and blood component transfusion per site standard care