An interventional study of XSTAT and Standard of Care in Shock, Hemorrhagic, Injury Penetrating and Hemorrhage, sponsored by University of Alabama at Birmingham. Terminated at 1 site in United States. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2024-12-30.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Treatment
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.
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:
81 studies on the registry are indexed under Shock, Hemorrhagic; 16 are open to participants now.
This study's enrollment of 1 is below the median of 100 across 42 interventional studies indexed under Shock, Hemorrhagic.
Browse Shock, Hemorrhagic studies →University of Alabama at Birmingham is the lead sponsor of 1,415 studies on the registry; 277 are open to participants now.
Of its 160 completed or terminated interventional studies of FDA-regulated products, 128 (80%) have results posted.
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Exclusion Criteria:
Participants randomized to the treatment arm will be treated using the study device - XSTAT.
Device: XSTAT
Participants assigned to the control group receive standard prehospital care, consisting of direct pressure/dressings.
Other: Standard of Care
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.
Also known as: XSTAT 12
As currently provided by EMS services
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.
Time frame: Each participant was assessed at the time of arrival in hospital
Record Blood Lactate Level Result
Record results of routine test
Time frame: Baseline - on admission
Base Deficit (mmol/l)
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.
Time frame: Baseline - on admission
Record Hemoglobin/Hematocrit Result
Record results of routine test
Time frame: Baseline - on admission
Record Platelet Count Result
Record results of routine test
Time frame: Baseline - on admission
Record Prothrombin Time Result
Record results of routine test
Time frame: Baseline - on admission
Record International Normalized Ratio (INR) Result
Record results of routine test
Time frame: Baseline - on admission
Record Activated Partial Thromboplastin Time (APTT) / Ratio Result
Record results of routine test
Time frame: Baseline - on admission
Record Thromboelastograph (TEG) Result if Available
Record results of routine test
Time frame: Baseline - on admission
Record Thromboelastogram (ROTEM) Result if Available
Record results of routine test
Time frame: Baseline - on admission
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.
Time frame: From baseline to 29 months (enrollment phase)
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
Time frame: From baseline to 29 months (enrollment phase)
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.
Time frame: Randomization through first 7 days, unless discharged earlier
Survival at 30 Days
Time of death, or survival at 30 days will be recorded
Time frame: Hospital admission through 30 days
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.
| Milestone | Treatment With XSTAT | Standard Care |
|---|---|---|
| Started | 0 | 1 |
| Completed | 0 | 1 |
| Not completed | 0 | 0 |
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.
| Participants | Treatment With XSTAT | Standard Care |
|---|---|---|
| Incidence of Patients With Hemorrhage From Junctional Wounds | 0 | 1 |
Record results of routine test
| mmol/l | Treatment With XSTAT | Standard Care |
|---|---|---|
| Record Blood Lactate Level Result | — | 3.5 |
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.
| mmol/l | Treatment With XSTAT | Standard Care |
|---|---|---|
| Base Deficit (mmol/l) | — | -2.1 |
Record results of routine test
| g/dL | Treatment With XSTAT | Standard Care |
|---|---|---|
| Record Hemoglobin/Hematocrit Result | — | 12.7 |
Record results of routine test
| 10^9 platelets/L | Treatment With XSTAT | Standard Care |
|---|---|---|
| Record Platelet Count Result | — | 267 |
Record results of routine test
| seconds | Treatment With XSTAT | Standard Care |
|---|---|---|
| Record Prothrombin Time Result | — | 13.8 |
Record results of routine test
| Ratio | Treatment With XSTAT | Standard Care |
|---|---|---|
| Record International Normalized Ratio (INR) Result | — | 1.1 |
Record results of routine test
| seconds | Treatment With XSTAT | Standard Care |
|---|---|---|
| Record Activated Partial Thromboplastin Time (APTT) / Ratio Result | — | 27 |
Record results of routine test
No measurements were reported for this outcome.
Record results of routine test
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Time of death, or survival at 30 days will be recorded
| participants | Treatment With XSTAT | Standard Care |
|---|---|---|
| Survival at 30 Days | — | 1 |
Collected over From admission to the level 1 trauma center until time of discharge from the level 1 trauma center, typically 28 days.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment With XSTAT | — | — | — |
| Standard Care | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
Only one patient was enrolled; additional data not provided to preserve confidentiality
| Age, Categorical(Participants) | Treatment With XSTAT | Standard Care | Total |
|---|---|---|---|
| <=18 years | — | 0 | 0 |
| Between 18 and 65 years | — | 1 | 1 |
| >=65 years | — | 0 | 0 |
| Sex/Gender, Customized(Participants) | Treatment With XSTAT | Standard Care | Total |
|---|---|---|---|
| Count of participants | — | NA | NA |
| Race and Ethnicity Not Collected(Participants) | Treatment With XSTAT | Standard Care | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Oct 2022 to primary completion in Jun 2023, 7 months.
Results were first posted in Dec 2024, 1 year 5 months after primary completion.
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This study is terminated, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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