Feasibility of Evaluating XSTAT Use in the Prehospital Setting

Hemorrhage Clinical Trial

— PhoXSTAT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04663087
• Other study ID #: IRB-300003647
• Status: Terminated
• Phase: N/A
• Start date: October 29, 2022
• Est. completion date: August 11, 2023

Study information

• Verified date: August 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: August 11, 2023
• Est. primary completion date: June 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemorrhage
• Injury Penetrating
• Shock, Hemorrhagic
• Wounds, Penetrating

Intervention

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:
• Standard of Care
As currently provided by EMS services

Locations

Country	Name	City	State
United States	UAB Hospital	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Record blood lactate level result	Record results of routine test	Baseline - on admission
Primary	Record base deficit result	Record results of routine test	Baseline - on admission
Primary	Record hemoglobin/hematocrit result	Record results of routine test	Baseline - on admission
Primary	Record platelet count result	Record results of routine test	Baseline - on admission
Primary	Record prothrombin time result	Record results of routine test	Baseline - on admission
Primary	Record international normalized ratio (INR) result	Record results of routine test	Baseline - on admission
Primary	Record activated partial thromboplastin time (APTT) / ratio result	Record results of routine test	Baseline - on admission
Primary	Record activated partial thromboplastin time (APTT) result	Record results of routine test	Baseline - on admission
Primary	Record thromboelastograph (TEG) result if available	Record results of routine test	Baseline - on admission
Primary	Record thromboelastogram (ROTEM) result if available	Record results of routine test	Baseline - on admission
Primary	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)
Primary	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)
Primary	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
Primary	Survival at 30 days	Time of death, or survival at 30 days will be recorded	Hospital admission through 30 days