Feasibility of Evaluating XSTAT Use in the Prehospital Setting (PhoXSTAT)

• ClinicalTrials.gov Identifier: NCT04663087
• Recruitment Status: Not yet recruiting
• First Posted: December 10, 2020
• Last Update Posted: March 8, 2022
• Sponsor: University of Alabama at Birmingham
• Information provided by (Responsible Party): Jan O. Jansen, University of Alabama at Birmingham

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Shock, Hemorrhagic; Injury Penetrating; Hemorrhage	Device: XSTAT; Other: Standard of Care	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Pilot Randomized Clinical Trial of the XSTAT Hemostatic Device in the Prehospital Setting
• Estimated Study Start Date: August 1, 2022
• Estimated Primary Completion Date: August 2023
• Estimated Study Completion Date: August 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Treatment with XSTAT; Participants randomized to the treatment arm will be treated using the study device - XSTAT.	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 Name: XSTAT 12
Standard Care; Participants assigned to the control group receive standard prehospital care, consisting of direct pressure/dressings.	Other: Standard of Care; As currently provided by EMS services

Outcome Measures

Primary Outcome Measures :

1. Incidence of patients with hemorrhage from junctional wounds [ Time Frame: Through 29 months ]
   The investigators will track the number of junctional wounds that are treated by participating EMS personnel versus the number of participants who were enrolled in this study. This will help the investigators understand how many wounds of this type happen, and how many would possibly benefit from the use of the XSTAT device.
2. Record blood lactate level result [ Time Frame: Baseline - on admission ]
   Record results of routine test
3. Record base deficit result [ Time Frame: Baseline - on admission ]
   Record results of routine test
4. Record hemoglobin/hematocrit result [ Time Frame: Baseline - on admission ]
   Record results of routine test
5. Record platelet count result [ Time Frame: Baseline - on admission ]
   Record results of routine test
6. Record prothrombin time result [ Time Frame: Baseline - on admission ]
   Record results of routine test
7. Record international normalized ratio (INR) result [ Time Frame: Baseline - on admission ]
   Record results of routine test
8. Record activated partial thromboplastin time (APTT) / ratio result [ Time Frame: Baseline - on admission ]
   Record results of routine test
9. Record activated partial thromboplastin time (APTT) result [ Time Frame: Baseline - on admission ]
   Record results of routine test
10. Record thromboelastograph (TEG) result if available [ Time Frame: Baseline - on admission ]
    Record results of routine test
11. Record thromboelastogram (ROTEM) result if available [ Time Frame: Baseline - on admission ]
    Record results of routine test
12. Ease of use of XSTAT device by EMS personnel [ Time Frame: From baseline to 29 months (enrollment phase) ]
    To answer the question "Is the XSTAT device easy to use in the prehospital setting," the study case report forms capture whether EMS personnel found the device easy to insert into a wound, whether the sponges were expelled from the device easily, and whether the EMS personnel were satisfied or dissatisfied with the XSTAT device itself.
13. Sponge removal: surgeon opinion of ease of removal, time required to remove sponges, use of x-rays, whether surgeon was satisfied or dissatisfied with the XSTAT device. [ Time Frame: From baseline to 29 months (enrollment phase) ]
    Case report forms capture whether sponges were easy to remove, how much time was required to remove the sponges, whether x-rays were obtained to ensure that no sponges were left in the body, and whether the surgeon was satisfied or dissatisfied with the XSTAT device
14. Adverse events from use of XSTAT device [ Time Frame: Randomization through first 7 days, unless discharged earlier ]
    All AEs, whether expected or unexpected will be recorded and reviewed throughout the trial. Each AE will be reported separately, with a description of the event, whether it was related to the device, whether it was serious, and whether it was expected or unexpected.
15. Survival at 30 days [ Time Frame: Hospital admission through 30 days ]
    Time of death, or survival at 30 days will be recorded

Eligibility Criteria

• Ages Eligible for Study: 15 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Karen N Brown, MSHA; 205-975-2393; karenbrown@uabmc.edu

Contact: Shannon Stephens, EMTP, CCEMTP; 205-934-5890; swstephens@uabmc.edu

Sponsors and Collaborators

University of Alabama at Birmingham

Investigators

• Principal Investigator: Jan Jansen, MBBS, PhD; The University of Alabama at Birmingham

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Jan O. Jansen, Primary Investigator, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT04663087
• Other Study ID Numbers: IRB-300003647
• First Posted: December 10, 2020
• Last Update Posted: March 8, 2022
• Last Verified: March 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Jan O. Jansen, University of Alabama at Birmingham:

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

Additional relevant MeSH terms:

Hemorrhage; Shock, Hemorrhagic; Wounds, Penetrating; Pathologic Processes; Shock; Wounds and Injuries