Hemorrhage Clinical Trial
— PhoXSTATOfficial title:
A Pilot Randomized Clinical Trial of the XSTAT Hemostatic Device in the Prehospital Setting
Verified date | August 2023 |
Source | University of Alabama at Birmingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | UAB Hospital | Birmingham | Alabama |
Lead Sponsor | Collaborator |
---|---|
University of Alabama at Birmingham |
United States,
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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