Feasibility of Evaluating XSTAT Use in the Prehospital Setting
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Hemorrhage
- Injury Penetrating
- Shock Hemorrhagic
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 15 years and 125 years
- Gender
- Both males and females
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, within 20 seconds of contact with blood, facilitating compression of bleeding structures. XSTAT® ca...
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, within 20 seconds of contact with blood, facilitating compression of bleeding structures. XSTAT® can be applied through skin wounds. The system can readily access deep vascular structures. While rapidly hemostatic, the hemostatic sponges are also relatively easy to remove. In the setting of junctional bleeding, XSTAT® may allow for hemostatic pressure generation from within the wound tract rather than from external compression (as with a tourniquet or manual compression). Hemorrhage should be controlled as early as possible, ideally before reaching a trauma center or medical treatment facility. Given its small size, low weight, and ease of application, the XSTAT® device is well-suited for prehospital use, in both the civilian and military setting, and this is probably where the device's applicability lies. The investigators anticipate that a full-scale trial will be conducted based on the questions this pilot study addresses, including the following: the number of penetrating junctional zone injuries encountered in the prehospital civilian setting. the feasibility of randomizing patients in the prehospital setting. usability. safety. validation of the proposed primary outcome of an efficacy trial.
Tracking Information
- NCT #
- NCT04663087
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Jan Jansen, MBBS, PhD The University of Alabama at Birmingham