ExanguinationNCT06622317
Abdominal Aortic Junction Tourniquet (AAJT-S) for Non-compressible Torso Haemorrhage
An observational study of Exanguination and NCTH, run by Medical University of Graz at 1 site in Austria.
Trial summary
This study seeks to evaluate the feasibility of a Abdominal Aortic Balloon Occlusion of the Aorta (AAJT-S) in exanguinating trauma patients with non-compressible truncal haemorrhage in the emergency room and the pre-hospital setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Exanguination, NCTH, Polytrauma
- How many people
- 10 participants
- Where
- 1 siteAustria
- Study dates
- 1 Nov 2024to 1 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all patients meeting the eligibility criteria that are being transported to the rescucitation room of the Medical University of Graz
Who may be able to join
- aged, or believed to be aged, 18 years or above,
- confirmed or suspected life-threatening lower body trauma (i.e. signs of inadequate perfusion of tissues, tachycardia, hypotension, suspected blood loss)
- is thought to benefit from trauma resuscitation with AAJT-S or REBOA zone III
Who cannot join
- suspected additional bleeding source proximal to the umbilicus, or
- known or suspected pregnancy at presentation, or
- known abdominal aortic aneurysm
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Graz
Graz, Styria, 8010
Gabriel Honnef, MD, PhD, 81283, gabriel.honnef@medunigraz.at
About this study
Official title: Abdominal Aortic Junction Tourniquet (AAJT-S) for Non-compressible Torso Haemorrhage: a Prospective Observational Pilot Study
This study seeks to evaluate the feasibility of a Abdominal Aortic Balloon Occlusion of the Aorta (AAJT-S) in exanguinating trauma patients with non-compressible truncal haemorrhage in the emergency room and the pre-hospital setting.
Read the detailed description
The study is designed as a prospective observational study to accomapany the impementation of this device in clinical routine. However, the device has already been used in the emergency room and AAJT-S application is no study specific intervention.
- Conditions
- Exanguination, NCTH, Polytrauma
- Keywords
- NCTH, aortic occlusion, exanguniation
- Medical subject headings
- Multiple Trauma
What is being measured
The primary outcome is the main question the study is designed to answer.
effective placement of the device
cessation of bloodflow distal to the device
Measured: 1 hour
Secondary outcomes (5)
30-day mortality
in-hospital
Measured: 30 days
Complications
Occurrence of complications of device application
Measured: 90 days
Heart rate
Improvement (reduction) in beats/minute
Measured: 1 hour
Base excess
Improvement (reduction) in mmol/l
Measured: 1hour
Blood pressure (systolic and diastolic)
Improvement in mmHg
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start1 Nov 2024
- Primary completion17 Sep 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExanguinationStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06622317
- Sponsor's protocol ID
- 1063/2024
- Status last verified
- Apr 2025
- First submitted
- 10 Sep 2024
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abdominal Aortic Junction Tourniquet (AAJT-S) for Non-compressible Torso Haemorrhage: a Prospective Observational Pilot Study
- ClinicalTrials.gov ID
- NCT06622317
- Acronym / sponsor ID
- 1063/2024
- Conditions
- Exanguination, NCTH, Polytrauma
- Keywords
- NCTH, aortic occlusion, exanguniation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 17 Sep 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 2 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study seeks to evaluate the feasibility of a Abdominal Aortic Balloon Occlusion of the Aorta (AAJT-S) in exanguinating trauma patients with non-compressible truncal haemorrhage in the emergency room and the pre-hospital setting.
Detailed description
The study is designed as a prospective observational study to accomapany the impementation of this device in clinical routine. However, the device has already been used in the emergency room and AAJT-S application is no study specific intervention.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patients meeting the eligibility criteria that are being transported to the rescucitation room of the Medical University of Graz
Key inclusion criteria (3 listed)
- aged, or believed to be aged, 18 years or above,
- confirmed or suspected life-threatening lower body trauma (i.e. signs of inadequate perfusion of tissues, tachycardia, hypotension, suspected blood loss)
- is thought to benefit from trauma resuscitation with AAJT-S or REBOA zone III
Key exclusion criteria (3 listed)
- suspected additional bleeding source proximal to the umbilicus, or
- known or suspected pregnancy at presentation, or
- known abdominal aortic aneurysm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
effective placement of the device
Time frame: 1 hour
cessation of bloodflow distal to the device
5 secondary outcomes
30-day mortality
Time frame: 30 days
Complications
Time frame: 90 days
Heart rate
Time frame: 1 hour
Base excess
Time frame: 1hour
Blood pressure (systolic and diastolic)
Time frame: 1 hour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Exanguination
RecruitingObservational study
Stability of Blood Clotting Products Stored in Emergency Ambulances Under Real-World Conditions
Exanguination, Trauma Coagulopathy
Not yet recruitingObservational study
Abdominal Aortic Junction Tourniquet (AAJT-S) for Non-compressible Torso Haemorrhage in the Prehospital and Emergency Room Setting
Exanguination, Polytrauma
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Exanguination and NCTH, run by Medical University of Graz at 1 site in Austria.
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: looking for participants now, as of the sponsor's last update on 17 Apr 2025. 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 Austria. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gabriel Honnef, MD, PhD (004331638581283, gabriel.honnef@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effective placement of the device (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Apr 2025.