Trial Outcomes & Findings for Feasibility of Evaluating XSTAT Use in the Prehospital Setting (NCT NCT04663087)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

1 participants

Primary outcome timeframe

Each participant was assessed at the time of arrival in hospital

Results posted on

2024-12-30

Participant Flow

This was a pilot/feasibility trial. The trial was conducted in the prehospital setting, and was an Exception From Informed Consent (EFIC) study. Patients were to be enrolled by EMS agencies. Only one patient was enrolled.

Participant milestones

Participant milestones
Measure	Treatment With XSTAT Participants randomized to the treatment arm will be treated using the study device - XSTAT. 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.	Standard Care Participants assigned to the control group receive standard prehospital care, consisting of direct pressure/dressings. Standard of Care: As currently provided by EMS services
Overall Study STARTED	0	1
Overall Study COMPLETED	0	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment With XSTAT Participants randomized to the treatment arm will be treated using the study device - XSTAT. 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.	Standard Care n=1 Participants Participants assigned to the control group receive standard prehospital care, consisting of direct pressure/dressings. Standard of Care: As currently provided by EMS services	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	—	0 Participants n=1 Participants	0 Participants n=1 Participants
Age, Categorical Between 18 and 65 years	—	1 Participants n=1 Participants	1 Participants n=1 Participants
Age, Categorical >=65 years	—	0 Participants n=1 Participants	0 Participants n=1 Participants
Sex/Gender, Customized	—	NA Participants n=1 Participants	NA Participants n=1 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Each participant was assessed at the time of arrival in hospital

Population: Only 1 patient enrolled

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.

Outcome measures

Outcome measures
Measure	Treatment With XSTAT Participants randomized to the treatment arm will be treated using the study device - XSTAT. 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.	Standard Care n=1 Participants Participants assigned to the control group receive standard prehospital care, consisting of direct pressure/dressings. Standard of Care: As currently provided by EMS services
Incidence of Patients With Hemorrhage From Junctional Wounds	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Baseline - on admission

Population: Only 1 patient enrolled

Record results of routine test

Outcome measures

Outcome measures
Measure	Treatment With XSTAT Participants randomized to the treatment arm will be treated using the study device - XSTAT. 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.	Standard Care n=1 Participants Participants assigned to the control group receive standard prehospital care, consisting of direct pressure/dressings. Standard of Care: As currently provided by EMS services
Record Blood Lactate Level Result	—	3.5 mmol/l

PRIMARY outcome

Timeframe: Baseline - on admission

Population: Only 1 patient enrolled

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.

Outcome measures

Outcome measures
Measure	Treatment With XSTAT Participants randomized to the treatment arm will be treated using the study device - XSTAT. 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.	Standard Care n=1 Participants Participants assigned to the control group receive standard prehospital care, consisting of direct pressure/dressings. Standard of Care: As currently provided by EMS services
Base Deficit (mmol/l)	—	-2.1 mmol/l

PRIMARY outcome

Timeframe: Baseline - on admission

Population: Only 1 patient enrolled

Record results of routine test

Outcome measures

Outcome measures
Measure	Treatment With XSTAT Participants randomized to the treatment arm will be treated using the study device - XSTAT. 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.	Standard Care n=1 Participants Participants assigned to the control group receive standard prehospital care, consisting of direct pressure/dressings. Standard of Care: As currently provided by EMS services
Record Hemoglobin/Hematocrit Result	—	12.7 g/dL

PRIMARY outcome

Timeframe: Baseline - on admission

Population: Only 1 patient enrolled

Record results of routine test

Outcome measures

Outcome measures
Measure	Treatment With XSTAT Participants randomized to the treatment arm will be treated using the study device - XSTAT. 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.	Standard Care n=1 Participants Participants assigned to the control group receive standard prehospital care, consisting of direct pressure/dressings. Standard of Care: As currently provided by EMS services
Record Platelet Count Result	—	267 10^9 platelets/L

PRIMARY outcome

Timeframe: Baseline - on admission

Population: Only 1 patient enrolled

Record results of routine test

Outcome measures

Outcome measures
Measure	Treatment With XSTAT Participants randomized to the treatment arm will be treated using the study device - XSTAT. 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.	Standard Care n=1 Participants Participants assigned to the control group receive standard prehospital care, consisting of direct pressure/dressings. Standard of Care: As currently provided by EMS services
Record Prothrombin Time Result	—	13.8 seconds

PRIMARY outcome

Timeframe: Baseline - on admission

Population: Only 1 patient enrolled

Record results of routine test

Outcome measures

Outcome measures
Measure	Treatment With XSTAT Participants randomized to the treatment arm will be treated using the study device - XSTAT. 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.	Standard Care n=1 Participants Participants assigned to the control group receive standard prehospital care, consisting of direct pressure/dressings. Standard of Care: As currently provided by EMS services
Record International Normalized Ratio (INR) Result	—	1.1 Ratio

PRIMARY outcome

Timeframe: Baseline - on admission

Population: Only 1 patient enrolled

Record results of routine test

Outcome measures

Outcome measures
Measure	Treatment With XSTAT Participants randomized to the treatment arm will be treated using the study device - XSTAT. 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.	Standard Care n=1 Participants Participants assigned to the control group receive standard prehospital care, consisting of direct pressure/dressings. Standard of Care: As currently provided by EMS services
Record Activated Partial Thromboplastin Time (APTT) / Ratio Result	—	27 seconds

PRIMARY outcome

Timeframe: Baseline - on admission

Population: Only 1 patient enrolled, who did not have this test done (which was not mandatory).

Record results of routine test

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline - on admission

Population: Only 1 patient enrolled, who did not have this test done (which was not mandatory).

Record results of routine test

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: From baseline to 29 months (enrollment phase)

Population: Only 1 patient enrolled, randomized to control arm

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: From baseline to 29 months (enrollment phase)

Population: Only 1 patient enrolled, randomized to control arm

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Randomization through first 7 days, unless discharged earlier

Population: Only 1 patient enrolled, randomized to control arm

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Hospital admission through 30 days

Population: Only 1 patient enrolled

Time of death, or survival at 30 days will be recorded

Outcome measures

Outcome measures
Measure	Treatment With XSTAT Participants randomized to the treatment arm will be treated using the study device - XSTAT. 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.	Standard Care n=1 Participants Participants assigned to the control group receive standard prehospital care, consisting of direct pressure/dressings. Standard of Care: As currently provided by EMS services
Survival at 30 Days	—	1 participants

Adverse Events

Treatment With XSTAT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jan Jansen

University of Alabama at Birmingham

Phone: 205-975-3030

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place