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

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

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.

Study Overview

• Status: Terminated
• Conditions: Hemorrhage; Shock, Hemorrhagic; Injury Penetrating
• Intervention / Treatment: Device: XSTAT; Other: Standard of 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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • UAB Hospital

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: XSTAT 12
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Record Blood Lactate Level Result	Record results of routine test	Baseline - on admission
Base Deficit (mmol/l)	Base excess and base deficit refer to an excess or deficit, respectively, in the amount of base present in the blood. The value is usually reported as a concentration in units of mEq/L (mmol/L), with positive numbers indicating an excess of base and negative a deficit. A typical reference range for base excess is -2 to +2 mEq/L. It is a test performed on a blood sample, venous or arterial. In trauma patients, a metabolic acidosis is indicative of the degree of shock, causing hypoperfusion. A more negative value indicates more severe acidosis, and more severe shock.	Baseline - on admission
Record Hemoglobin/Hematocrit Result	Record results of routine test	Baseline - on admission
Record Platelet Count Result	Record results of routine test	Baseline - on admission
Record Prothrombin Time Result	Record results of routine test	Baseline - on admission
Record International Normalized Ratio (INR) Result	Record results of routine test	Baseline - on admission
Record Activated Partial Thromboplastin Time (APTT) / Ratio Result	Record results of routine test	Baseline - on admission
Record Thromboelastograph (TEG) Result if Available	Record results of routine test	Baseline - on admission
Record Thromboelastogram (ROTEM) Result if Available	Record results of routine test	Baseline - on admission
Ease of Use of XSTAT Device by EMS Personnel	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.	From baseline to 29 months (enrollment phase)
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.	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	From baseline to 29 months (enrollment phase)
Adverse Events From Use of XSTAT Device	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.	Randomization through first 7 days, unless discharged earlier
Survival at 30 Days	Time of death, or survival at 30 days will be recorded	Hospital admission through 30 days
Incidence of Patients With Hemorrhage From Junctional Wounds	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.	Each participant was assessed at the time of arrival in hospital

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2022
• Primary Completion (Actual): June 21, 2023
• Study Completion (Actual): August 11, 2023

Study Registration Dates

• First Submitted: October 7, 2019
• First Submitted That Met QC Criteria: December 4, 2020
• First Posted (Actual): December 10, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: prehospital; hemorrhagic shock; penetrating injury; hemostatic sponge; junctional wounds
• Additional Relevant MeSH Terms: Wounds and Injuries; Pathologic Processes; Shock; Hemorrhage; Shock, Hemorrhagic; Wounds, Penetrating
• Other Study ID Numbers: IRB-300003647

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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