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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04663087
Other study ID # IRB-300003647
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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