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

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

Tracking Information
First Submitted Date  ICMJE October 7, 2019
First Posted Date  ICMJE December 10, 2020
Last Update Posted Date March 8, 2022
Estimated Study Start Date  ICMJE August 1, 2022
Estimated Primary Completion Date August 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2020)
  • 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.
  • Record blood lactate level result [ Time Frame: Baseline - on admission ]
    Record results of routine test
  • Record base deficit result [ Time Frame: Baseline - on admission ]
    Record results of routine test
  • Record hemoglobin/hematocrit result [ Time Frame: Baseline - on admission ]
    Record results of routine test
  • Record platelet count result [ Time Frame: Baseline - on admission ]
    Record results of routine test
  • Record prothrombin time result [ Time Frame: Baseline - on admission ]
    Record results of routine test
  • Record international normalized ratio (INR) result [ Time Frame: Baseline - on admission ]
    Record results of routine test
  • Record activated partial thromboplastin time (APTT) / ratio result [ Time Frame: Baseline - on admission ]
    Record results of routine test
  • Record activated partial thromboplastin time (APTT) result [ Time Frame: Baseline - on admission ]
    Record results of routine test
  • Record thromboelastograph (TEG) result if available [ Time Frame: Baseline - on admission ]
    Record results of routine test
  • Record thromboelastogram (ROTEM) result if available [ Time Frame: Baseline - on admission ]
    Record results of routine test
  • 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.
  • 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
  • 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.
  • Survival at 30 days [ Time Frame: Hospital admission through 30 days ]
    Time of death, or survival at 30 days will be recorded
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feasibility of Evaluating XSTAT Use in the Prehospital Setting
Official Title  ICMJE A Pilot Randomized Clinical Trial of the XSTAT Hemostatic Device in the Prehospital Setting
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Shock, Hemorrhagic
  • Injury Penetrating
  • Hemorrhage
Intervention  ICMJE
  • 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
  • Other: Standard of Care
    As currently provided by EMS services
Study Arms  ICMJE
  • Experimental: Treatment with XSTAT
    Participants randomized to the treatment arm will be treated using the study device - XSTAT.
    Intervention: Device: XSTAT
  • Standard Care
    Participants assigned to the control group receive standard prehospital care, consisting of direct pressure/dressings.
    Intervention: Other: Standard of Care
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: December 4, 2020)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2023
Estimated Primary Completion Date August 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Karen N Brown, MSHA 205-975-2393 karenbrown@uabmc.edu
Contact: Shannon Stephens, EMTP, CCEMTP 205-934-5890 swstephens@uabmc.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04663087
Other Study ID Numbers  ICMJE IRB-300003647
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Jan O. Jansen, University of Alabama at Birmingham
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Alabama at Birmingham
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jan Jansen, MBBS, PhD The University of Alabama at Birmingham
PRS Account University of Alabama at Birmingham
Verification Date March 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP