Feasibility of Evaluating XSTAT Use in the Prehospital Setting

NCT04663087 | Terminated Results DMC FDA Device

• 1 other identifier: IRB-300003647
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Shock, Hemorrhagic; Injury Penetrating; Hemorrhage

Keywords

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

Outcome Measures

Primary Outcomes (14)

• 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

• 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

Study Arms (2)

Treatment with XSTAT

EXPERIMENTAL

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

Device: XSTAT

Standard Care

OTHER

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

Other: Standard of Care

Interventions

XSTAT 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.

Also known as: XSTAT 12

Treatment with XSTAT

Standard of Care OTHER

As currently provided by EMS services

Standard Care

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥15 years or estimated body weight ≥50 kg.
• Penetrating junctional injury (femoral or axillary), with i. visible bleeding ii. too proximal to be controlled with a tourniquet
• Patient will be taken to participating level I trauma center, directly from the scene

You may not qualify if:

• Prisoners, children \<15 years old, known pregnant patients.
• Patients receiving chest compressions (prior to XSTAT® use).
• Patients with an opt-out bracelet.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

UAB Hospital

Birmingham, Alabama, 35233, United States

Location

Related Publications (1)

• 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.

  PMID: 34620774 DERIVED

MeSH Terms

Conditions

Shock, Hemorrhagic; Wounds, Penetrating; Hemorrhage

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Dr. Jan Jansen
• Organization: University of Alabama at Birmingham

jjansen@uabmc.edu

205-975-3030

Study Officials

• Jan Jansen, MBBS, PhD

  The University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: October 7, 2019
• First Posted: December 10, 2020
• Study Start: October 29, 2022
• Primary Completion: June 21, 2023
• Study Completion: August 11, 2023
• Last Updated: December 30, 2024
• Results First Posted: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)