Feasibility of Evaluating XSTAT Use in the Prehospital Setting

Study Overview
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Brief Summary
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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
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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: the number of penetrating junctional zone injuries encountered in the prehospital civilian setting. the feasibility of randomizing patients in the prehospital setting. usability. safety. validation of the proposed primary outcome of an efficacy trial.

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

Conditions
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Shock, Hemorrhagic, Injury Penetrating, Hemorrhage

Intervention / Treatment
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* Device: XSTAT
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Prisoners, children <15 years old, known pregnant patients. Patients receiving chest compressions (prior to XSTAT® use). Patients with an opt-out bracelet.

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Through 29 months | 
| Record blood lactate level result | Record results of routine test | Baseline - on admission | 
| Record base deficit result | Record results of routine test | 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 activated partial thromboplastin time (APTT) 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemorrhagic shock, hemostatic sponge, penetrating injury, junctional wounds, prehospital