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Sponsor stopped enrollment
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with XSTAT | Experimental | Participants randomized to the treatment arm will be treated using the study device - XSTAT. |
|
| Standard Care | Other | Participants assigned to the control group receive standard prehospital care, consisting of direct pressure/dressings. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XSTAT | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Each participant was assessed at the time of arrival in hospital |
| Record Blood Lactate Level Result | Record results of routine test | 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. | Baseline - on admission |
| Record Hemoglobin/Hematocrit Result | Record results of routine test | Baseline - on admission |
| Record Platelet Count Result | Record results of routine test | Baseline - on admission |
| Record Prothrombin Time Result | Record results of routine test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Jansen, MBBS, PhD | The University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Hospital | Birmingham | Alabama | 35233 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34620774 | Derived | Stephens SW, Farley P, Collins SP, Wong MD, Panas AB, Dennis BM, Richmond N, Inaba K, Brown KN, Holcomb JB, Jansen JO. Multicenter social media community consultation for an exception from informed consent trial of the XStat device (PhoXStat trial). J Trauma Acute Care Surg. 2022 Feb 1;92(2):442-446. doi: 10.1097/TA.0000000000003425. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Only one patient was enrolled; additional data not provided to preserve confidentiality
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Only 1 patient enrolled | Posted | Count of Participants | Participants | Each participant was assessed at the time of arrival in hospital |
|
From admission to the level 1 trauma center until time of discharge from the level 1 trauma center, typically 28 days.
Standard definitions
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jan Jansen | University of Alabama at Birmingham | 205-975-3030 | jjansen@uabmc.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 23, 2021 | Jul 30, 2024 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D012771 | Shock, Hemorrhagic |
| D014950 | Wounds, Penetrating |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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|
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| Standard of Care | Other | As currently provided by EMS services |
|
| Baseline - on admission |
| Record International Normalized Ratio (INR) Result | Record results of routine test | Baseline - on admission |
| Record Activated Partial Thromboplastin Time (APTT) / Ratio Result | Record results of routine test | Baseline - on admission |
| Record Thromboelastograph (TEG) Result if Available | Record results of routine test | Baseline - on admission |
| Record Thromboelastogram (ROTEM) Result if Available | Record results of routine test | 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. | 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 | 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. | Randomization through first 7 days, unless discharged earlier |
| Survival at 30 Days | Time of death, or survival at 30 days will be recorded | Hospital admission through 30 days |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG001 | 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 |
|
|
| Primary | Record Blood Lactate Level Result | Record results of routine test | Only 1 patient enrolled | Posted | Number | mmol/l | Baseline - on admission |
|
|
|
| Primary | 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. | Only 1 patient enrolled | Posted | Number | mmol/l | Baseline - on admission |
|
|
|
| Primary | Record Hemoglobin/Hematocrit Result | Record results of routine test | Only 1 patient enrolled | Posted | Number | g/dL | Baseline - on admission |
|
|
|
| Primary | Record Platelet Count Result | Record results of routine test | Only 1 patient enrolled | Posted | Number | 10^9 platelets/L | Baseline - on admission |
|
|
|
| Primary | Record Prothrombin Time Result | Record results of routine test | Only 1 patient enrolled | Posted | Number | seconds | Baseline - on admission |
|
|
|
| Primary | Record International Normalized Ratio (INR) Result | Record results of routine test | Only 1 patient enrolled | Posted | Number | Ratio | Baseline - on admission |
|
|
|
| Primary | Record Activated Partial Thromboplastin Time (APTT) / Ratio Result | Record results of routine test | Only 1 patient enrolled | Posted | Number | seconds | Baseline - on admission |
|
|
|
| Primary | Record Thromboelastograph (TEG) Result if Available | Record results of routine test | Only 1 patient enrolled, who did not have this test done (which was not mandatory). | Posted | Baseline - on admission |
|
|
| Primary | Record Thromboelastogram (ROTEM) Result if Available | Record results of routine test | Only 1 patient enrolled, who did not have this test done (which was not mandatory). | Posted | 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. | Only 1 patient enrolled, randomized to control arm | Posted | 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 | Only 1 patient enrolled, randomized to control arm | Posted | 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. | Only 1 patient enrolled, randomized to control arm | Posted | Randomization through first 7 days, unless discharged earlier |
|
|
| Primary | Survival at 30 Days | Time of death, or survival at 30 days will be recorded | Only 1 patient enrolled | Posted | Number | participants | Hospital admission through 30 days |
|
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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 | 0 | 1 | 0 | 1 | 0 | 1 |
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