Hemorrhage, Injury Penetrating, Shock, Hemorrhagic
Conditions
Keywords
hemorrhagic shock, hemostatic sponge, penetrating injury, junctional wounds, prehospital
Brief 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.
Detailed 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.
Interventions
DEVICEXSTAT
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.
OTHERStandard of Care
As currently provided by EMS services
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Patients With Hemorrhage From Junctional Wounds | Each participant was assessed at the time of arrival in hospital | 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. |
| Record Blood Lactate Level Result | Baseline - on admission | Record results of routine test |
| Base Deficit (mmol/l) | Baseline - on admission | 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. |
| Record Hemoglobin/Hematocrit Result | Baseline - on admission | Record results of routine test |
| Record Platelet Count Result | Baseline - on admission | Record results of routine test |
| Record Prothrombin Time Result | Baseline - on admission | Record results of routine test |
| Record International Normalized Ratio (INR) Result | Baseline - on admission | Record results of routine test |
| Record Activated Partial Thromboplastin Time (APTT) / Ratio Result | Baseline - on admission | Record results of routine test |
| Record Thromboelastograph (TEG) Result if Available | Baseline - on admission | Record results of routine test |
| Record Thromboelastogram (ROTEM) Result if Available | Baseline - on admission | Record results of routine test |
| Ease of Use of XSTAT Device by EMS Personnel | From baseline to 29 months (enrollment phase) | 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. |
| 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. | From baseline to 29 months (enrollment phase) | 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 |
| Adverse Events From Use of XSTAT Device | Randomization through first 7 days, unless discharged earlier | 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. |
| Survival at 30 Days | Hospital admission through 30 days | Time of death, or survival at 30 days will be recorded |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 0 |
| 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 | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Standard Care | Total |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants |
| Sex/Gender, Customized | NA Participants | NA Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 1 |
| other Total, other adverse events | 0 / 0 | 0 / 1 |
| serious Total, serious adverse events | 0 / 0 | 0 / 1 |
Outcome results
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.
Time frame: Randomization through first 7 days, unless discharged earlier
Population: Only 1 patient enrolled, randomized to control arm
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.
Time frame: Baseline - on admission
Population: Only 1 patient enrolled
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Care | Base Deficit (mmol/l) | -2.1 mmol/l |
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.
Time frame: From baseline to 29 months (enrollment phase)
Population: Only 1 patient enrolled, randomized to control arm
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.
Time frame: Each participant was assessed at the time of arrival in hospital
Population: Only 1 patient enrolled
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment With XSTAT | Incidence of Patients With Hemorrhage From Junctional Wounds | 0 Participants |
| Standard Care | Incidence of Patients With Hemorrhage From Junctional Wounds | 1 Participants |
Primary
Record Activated Partial Thromboplastin Time (APTT) / Ratio Result
Record results of routine test
Time frame: Baseline - on admission
Population: Only 1 patient enrolled
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Care | Record Activated Partial Thromboplastin Time (APTT) / Ratio Result | 27 seconds |
Primary
Record Blood Lactate Level Result
Record results of routine test
Time frame: Baseline - on admission
Population: Only 1 patient enrolled
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Care | Record Blood Lactate Level Result | 3.5 mmol/l |
Primary
Record Hemoglobin/Hematocrit Result
Record results of routine test
Time frame: Baseline - on admission
Population: Only 1 patient enrolled
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Care | Record Hemoglobin/Hematocrit Result | 12.7 g/dL |
Primary
Record International Normalized Ratio (INR) Result
Record results of routine test
Time frame: Baseline - on admission
Population: Only 1 patient enrolled
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Care | Record International Normalized Ratio (INR) Result | 1.1 Ratio |
Primary
Record Platelet Count Result
Record results of routine test
Time frame: Baseline - on admission
Population: Only 1 patient enrolled
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Care | Record Platelet Count Result | 267 10^9 platelets/L |
Primary
Record Prothrombin Time Result
Record results of routine test
Time frame: Baseline - on admission
Population: Only 1 patient enrolled
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Care | Record Prothrombin Time Result | 13.8 seconds |
Primary
Record Thromboelastogram (ROTEM) Result if Available
Record results of routine test
Time frame: Baseline - on admission
Population: Only 1 patient enrolled, who did not have this test done (which was not mandatory).
Primary
Record Thromboelastograph (TEG) Result if Available
Record results of routine test
Time frame: Baseline - on admission
Population: Only 1 patient enrolled, who did not have this test done (which was not mandatory).
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
Time frame: From baseline to 29 months (enrollment phase)
Population: Only 1 patient enrolled, randomized to control arm
Primary
Survival at 30 Days
Time of death, or survival at 30 days will be recorded
Time frame: Hospital admission through 30 days
Population: Only 1 patient enrolled
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Care | Survival at 30 Days | 1 participants |