Feasibility of Evaluating XSTAT Use in the Prehospital Setting

NCT ID: NCT04663087

Last Updated: 2024-12-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-29
• Study Completion Date: 2023-08-11

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, 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

Keywords

hemorrhagic shock; hemostatic sponge; penetrating injury; junctional wounds; prehospital

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment with XSTAT

Participants randomized to the treatment arm will be treated using the study device - XSTAT.

Group Type: EXPERIMENTAL

XSTAT

Intervention Type: DEVICE

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.

Standard Care

Participants assigned to the control group receive standard prehospital care, consisting of direct pressure/dressings.

Group Type: OTHER

Standard of Care

Intervention Type: OTHER

As currently provided by EMS services

Interventions

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.

Intervention Type: DEVICE

Standard of Care

As currently provided by EMS services

Intervention Type: OTHER

Other Intervention Names

XSTAT 12

Eligibility Criteria

Inclusion Criteria

1. Age ≥15 years or estimated body weight ≥50 kg.

2. Penetrating junctional injury (femoral or axillary), with i. visible bleeding ii. too proximal to be controlled with a tourniquet

3. Patient will be taken to participating level I trauma center, directly from the scene

Exclusion Criteria

1. Prisoners, children <15 years old, known pregnant patients.

2. Patients receiving chest compressions (prior to XSTAT® use).

3. Patients with an opt-out bracelet.

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Jan O. Jansen

Primary Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jan Jansen, MBBS, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Alabama at Birmingham

Locations

UAB Hospital

Birmingham, Alabama, United States

Countries

United States

References

Stephens SW, Farley P, Collins SP, Wong MD, Panas AB, Dennis BM, Richmond N, Inaba K, Brown KN, Holcomb JB, Jansen JO. Multicenter social media community consultation for an exception from informed consent trial of the XStat device (PhoXStat trial). J Trauma Acute Care Surg. 2022 Feb 1;92(2):442-446. doi: 10.1097/TA.0000000000003425.

Reference Type: DERIVED

PMID: 34620774 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

IRB-300003647

Identifier Type: -

Identifier Source: org_study_id