Shock, HemorrhagicPhoXSTATNCT04663087
Feasibility of Evaluating XSTAT Use in the Prehospital Setting
A study testing XSTAT in people with Shock, Hemorrhagic and Injury Penetrating, run by University of Alabama at Birmingham at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Shock, Hemorrhagic, Injury Penetrating, Hemorrhage
- What is being tested?
- XSTAT
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2022to 11 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥15 years or estimated body weight ≥50 kg.
- Penetrating junctional injury (femoral or axillary), with i. visible bleeding ii. too proximal to be controlled with a tourniquet
- Patient will be taken to participating level I trauma center, directly from the scene
Who cannot join
- Prisoners, children <15 years old, known pregnant patients.
- Patients receiving chest compressions (prior to XSTAT® use).
- Patients with an opt-out bracelet.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Randomized Clinical Trial of the XSTAT Hemostatic Device in the Prehospital Setting
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.
Read the 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:
- the number of penetrating junctional zone injuries encountered in the prehospital civilian setting.
- the feasibility of randomizing patients in the prehospital setting.
- usability.
- safety.
- validation of the proposed primary outcome of an efficacy trial.
- Conditions
- Shock, Hemorrhagic, Injury Penetrating, Hemorrhage
- Being tested
- XSTAT, Standard of Care
- Keywords
- hemorrhagic shock, hemostatic sponge, penetrating injury, junctional wounds, prehospital
- Medical subject headings
- Shock, Hemorrhagic, Wounds, Penetrating, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XSTATDevice
Also called XSTAT 12
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.
Standard of CareOther
As currently provided by EMS services
| Study group | Role | What they receive |
|---|---|---|
| Treatment with XSTAT | Experimental | Participants randomized to the treatment arm will be treated using the study device - XSTAT. Receives: Device: XSTAT |
| Standard Care | Other | Participants assigned to the control group receive standard prehospital care, consisting of direct pressure/dressings. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Each participant was assessed at the time of arrival in hospital
Record Blood Lactate Level Result
Record results of routine test
Measured: 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.
Measured: Baseline - on admission
Record Hemoglobin/Hematocrit Result
Record results of routine test
Measured: Baseline - on admission
Record Platelet Count Result
Record results of routine test
Measured: Baseline - on admission
Record Prothrombin Time Result
Record results of routine test
Measured: Baseline - on admission
Record International Normalized Ratio (INR) Result
Record results of routine test
Measured: Baseline - on admission
Record Activated Partial Thromboplastin Time (APTT) / Ratio Result
Record results of routine test
Measured: Baseline - on admission
Record Thromboelastograph (TEG) Result if Available
Record results of routine test
Measured: Baseline - on admission
Record Thromboelastogram (ROTEM) Result if Available
Record results of routine test
Measured: 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.
Measured: 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
Measured: 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.
Measured: Randomization through first 7 days, unless discharged earlier
Survival at 30 Days
Time of death, or survival at 30 days will be recorded
Measured: Hospital admission through 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start29 Oct 2022
- Primary completion21 Jun 2023
- Study completion11 Aug 2023
Why it stopped: Sponsor stopped enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shock, HemorrhagicStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan O. Jansen, University of Alabama at Birmingham
- Investigators
- Jan Jansen, MBBS, PhD, Principal investigator, The University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04663087
- Sponsor's protocol ID
- IRB-300003647
- Acronym
- PhoXSTAT
- Status last verified
- Dec 2024
- First submitted
- 7 Oct 2019
- Last updated
- 30 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 34620774
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Clinical Trial of the XSTAT Hemostatic Device in the Prehospital Setting
- ClinicalTrials.gov ID
- NCT04663087
- Acronym / sponsor ID
- PhoXSTAT / IRB-300003647
- Conditions
- Shock, Hemorrhagic, Injury Penetrating, Hemorrhage
- Keywords
- hemorrhagic shock, hemostatic sponge, penetrating injury, junctional wounds, prehospital
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor stopped enrollment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 29 Oct 2022 (actual)
- Primary completion
- 21 Jun 2023 (actual)
- Study completion
- 11 Aug 2023 (actual)
- First posted
- 10 Dec 2020 (actual)
- Results
- Posted 11 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- the number of penetrating junctional zone injuries encountered in the prehospital civilian setting.
- the feasibility of randomizing patients in the prehospital setting.
- usability.
- safety.
- validation of the proposed primary outcome of an efficacy trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment with XSTAT | Experimental | Device: XSTATParticipants randomized to the treatment arm will be treated using the study device - XSTAT. |
| Standard Care | Other | Other: Standard of CareParticipants assigned to the control group receive standard prehospital care, consisting of direct pressure/dressings. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥15 years or estimated body weight ≥50 kg.
- Penetrating junctional injury (femoral or axillary), with i. visible bleeding ii. too proximal to be controlled with a tourniquet
- Patient will be taken to participating level I trauma center, directly from the scene
Key exclusion criteria (3 listed)
- Prisoners, children <15 years old, known pregnant patients.
- Patients receiving chest compressions (prior to XSTAT® use).
- Patients with an opt-out bracelet.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XSTATAlso: XSTAT 12XSTAT 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. | Device | Treatment with XSTAT |
| Standard of CareAs currently provided by EMS services | Other | Standard Care |
Primary outcome
Incidence of Patients With Hemorrhage From Junctional Wounds
Time frame: 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
Time frame: Baseline - on admission
Record results of routine test
Base Deficit (mmol/l)
Time frame: 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
Time frame: Baseline - on admission
Record results of routine test
Record Platelet Count Result
Time frame: Baseline - on admission
Record results of routine test
Record Prothrombin Time Result
Time frame: Baseline - on admission
Record results of routine test
Record International Normalized Ratio (INR) Result
Time frame: Baseline - on admission
Record results of routine test
Record Activated Partial Thromboplastin Time (APTT) / Ratio Result
Time frame: Baseline - on admission
Record results of routine test
Record Thromboelastograph (TEG) Result if Available
Time frame: Baseline - on admission
Record results of routine test
Record Thromboelastogram (ROTEM) Result if Available
Time frame: Baseline - on admission
Record results of routine test
Ease of Use of XSTAT Device by EMS Personnel
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: Hospital admission through 30 days
Time of death, or survival at 30 days will be recorded
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34620774Stephens 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.
- Individual participant dataSharing planned: No
Related trials for Shock, Hemorrhagic
RecruitingPhase 2
CAlcium and VAsopressin Following Injury Early Resuscitation (CAVALIER) Trial
Trauma, Hemorrhage
RecruitingPhase 4
Adult Outpatient Linvoseltamab With Tocilizumab Prophylaxis to Mitigate the Risk of Cytokine Release Syndrome (CRS)
Relapsed/Refractory Multiple Myeloma (RRMM)
Enrolling by invitationObservational study
Cryo-FIRST: Effectiveness of INTERCEPT Fibrinogen Complex (IFC) for Trauma-Associated Hemorrhage
Hypofibrinogenemia, Hemorrhage
RecruitingPhase 4
The Safety of Simplified Tranexamic Acid Regimen
Trauma Coagulopathy, Hemorrhage
RecruitingPhase 2
Infliximab for Cytokine Release Syndrome Prophylaxis During Teclistamab or Talquetamab Therapy in Patients With Relapsed or Refractory Myeloma
Cytokine Release Syndrome, Recurrent Multiple Myeloma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Jansen, MBBS, PhD principal investigator
The University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing XSTAT in people with Shock, Hemorrhagic and Injury Penetrating, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Patients With Hemorrhage From Junctional Wounds (time frame: Each participant was assessed at the time of arrival in hospital). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04663087, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2024.