Feasibility of Evaluating XSTAT Use in the Prehospital Setting

Not Applicable

Terminated

• Conditions: Shock, Hemorrhagic; Injury Penetrating; Hemorrhage
• Interventions: Other: Standard of Care; Device: XSTAT

• Registration Number: NCT04663087
• Lead Sponsor: University of Alabama at Birmingham

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2019-10-07
• Study First Submitted QC: 2020-12-04
• Study First Posted: 2020-12-10
• Study Start: 2022-10-29
• Primary Completion: 2023-06-21
• Study Completion: 2023-08-11
• Results First Submitted: 2024-06-12
• Status Verified: 2024-12
• Results First Submitted QC: 2024-12-03
• Results First Posted: 2024-12-11
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Care	Standard of Care	Participants assigned to the control group receive standard prehospital care, consisting of direct pressure/dressings.
Treatment with XSTAT	XSTAT	Participants randomized to the treatment arm will be treated using the study device - XSTAT.

Primary Outcome Measures

Name	Time	Method
Incidence of Patients With Hemorrhage From Junctional Wounds	Each participant was assessed at the time of arrival in hospital	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	Baseline - on admission	Record results of routine test
Base Deficit (mmol/l)	Baseline - on admission	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.
Record Hemoglobin/Hematocrit Result	Baseline - on admission	Record results of routine test
Record Platelet Count Result	Baseline - on admission	Record results of routine test
Record Prothrombin Time Result	Baseline - on admission	Record results of routine test
Record International Normalized Ratio (INR) Result	Baseline - on admission	Record results of routine test
Record Activated Partial Thromboplastin Time (APTT) / Ratio Result	Baseline - on admission	Record results of routine test
Record Thromboelastograph (TEG) Result if Available	Baseline - on admission	Record results of routine test
Record Thromboelastogram (ROTEM) Result if Available	Baseline - on admission	Record results of routine test
Ease of Use of XSTAT Device by EMS Personnel	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.	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	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	Hospital admission through 30 days	Time of death, or survival at 30 days will be recorded

Trial Locations

Locations (1)

UAB Hospital; 🇺🇸 Birmingham, Alabama, United States