Cold Stored Platelet in Hemorrhagic Shock
Completed · Phase 2
Conditions studied: Trauma, Hemorrhage
In brief
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.
Key facts
- Study ID
- NCT04667468
- Run by
- Jason Sperry
- People needed
- 200
- Starts
- 2022-06-21
- Expected to finish
- 2023-11-20
- Last updated by the study team
- 2024-12-18
Who can join
Age: 15 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- University of Southern California — Los Angeles, California, United States
- University of California San Francisco — San Francisco, California, United States
- University of Mississippi — Jackson, Mississippi, United States
- Baylor College of Medicine — Houston, Texas, United States
- University of Texas Health Sciences Center Houston — Houston, Texas, United States
Full record on ClinicalTrials.gov
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