NCT04663087

Feasibility of Evaluating XSTAT Use in the Prehospital Setting

A Pilot Randomized Clinical Trial of the XSTAT Hemostatic Device in the Prehospital Setting

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

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, 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: 1. the number of penetrating junctional zone injuries encountered in the prehospital civilian setting. 2. the feasibility of randomizing patients in the prehospital setting. 3. usability. 4. safety. 5. validation of the proposed primary outcome of an efficacy trial.

Conditions

• Shock, Hemorrhagic
• Injury Penetrating
• Hemorrhage

Interventions

Type	Name	Description
DEVICE	XSTAT	XSTAT application will follow the manufacturer's guidance, with injection into bleeding junctional wounds. A sufficient number of sponges are used to fill the injury void. Repeated XSTAT application is performed in the event of persistent bleeding. The trial packs will contain two devices.
OTHER	Standard of Care	As currently provided by EMS services

Timeline

• Start date: 2022-10-29
• Primary completion: 2023-06-21
• Completion: 2023-08-11
• First posted: 2020-12-10
• Last updated: 2024-12-30
• Results posted: 2024-12-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study