Status:
TERMINATED
Feasibility of Evaluating XSTAT Use in the Prehospital Setting
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Shock, Hemorrhagic
Injury Penetrating
Eligibility:
All Genders
15+ years
Phase:
NA
Brief Summary
This study evaluates the prehospital use of the XSTAT device to control bleeding in junctional wounds. Participants will be randomized to the use of XSTAT versus standard care.
Detailed Description
The XSTAT® device injects small, rapidly-expanding cellulose sponges into the wound cavity using a syringe-like delivery system. In the wound, XSTAT® sponges expand and swell to fill the wound cavity,...
Eligibility Criteria
Inclusion
- Age ≥15 years or estimated body weight ≥50 kg.
- Penetrating junctional injury (femoral or axillary), with i. visible bleeding ii. too proximal to be controlled with a tourniquet
- Patient will be taken to participating level I trauma center, directly from the scene
Exclusion
- Prisoners, children \<15 years old, known pregnant patients.
- Patients receiving chest compressions (prior to XSTAT® use).
- Patients with an opt-out bracelet.
Key Trial Info
Start Date :
October 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 11 2023
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04663087
Start Date
October 29 2022
End Date
August 11 2023
Last Update
December 30 2024
Active Locations (1)
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1
UAB Hospital
Birmingham, Alabama, United States, 35233