Non-compressible Torso HemorrhageNCT05941572
Resuscitative Endovascular Balloon Occlusion of the Aorta in Haemorrhagic Shock
An observational study of Non-compressible Torso Hemorrhage and Trauma Injury, run by Medical University of Graz at 1 site in Austria.
Trial summary
Resuscitative endovascular balloon occlusion of the aorta (REBOA) is a procedure that has the goal to stabilize trauma patients with non-compressible torso hemorrhage by temporarily occluding the aorta with a ballon catheter to increase central perfusion and stop uncontrollable bleeding from the diaphragm downwards. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-compressible Torso Hemorrhage, Trauma Injury
- How many people
- 0 participants
- Where
- 1 siteAustria
- Study dates
- 28 Jun 2023to 1 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Trauma patients with non-compressible torso hemorrhage and REBOA placement in the initial resuscitation phase.
Who may be able to join
- Patient with non-compressible torso hemorrhage following major trauma with REBOA placement
- age>18 years
- REBOA placement during the initial resuscitation
Who cannot join
- age<18 years
- missing data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) in Patients With Major Trauma and Uncontrolled Haemorrhagic Shock: a Retrospective Analysis
Resuscitative endovascular balloon occlusion of the aorta (REBOA) is a procedure that has the goal to stabilize trauma patients with non-compressible torso hemorrhage by temporarily occluding the aorta with a ballon catheter to increase central perfusion and stop uncontrollable bleeding from the diaphragm downwards.
The investigators are planning to evaluate all patients who had a REBOA catheter placed at their clinic or in the pre-clinical setting from the start of 2019 to the 31.12.2022 who were transferred to their clinic, with basic demographic and clinical data, the procedural specifics, and their potential complications.
Read the detailed description
Resuscitative endovascular balloon occlusion of the aorta (REBOA) is a procedure that has the goal stabilize trauma patients with non-compressible torso hemorrhage by temporarily occluding the aorta with a ballon catheter to increase central perfusion and stop uncontrollable bleeding from the diaphragm downwards.
The investigators plan to evaluate all patients who had a REBOA catheter placed at their clinic or in the pre-clinical setting from the start of 2019 to the 31.12.2022 who were transferred to their clinic, with basic demographic and clinical data, the procedural specifics, and their potential complications.
Investigators will search for patients who had a REBOA catheter placed in the study period in the clinical documentation system (openMEDOCS) and the database of the German trauma registry. Documentation will include hemodynamic parameters, transfused blood products, complications, basic demographics and mortality up to thirty days after REBOA placement.
The investigators will then try to find patients with similar trauma mechanism and severity of trauma in the German trauma registry and match them with their REBOA patients.
- Conditions
- Non-compressible Torso Hemorrhage, Trauma Injury
- Keywords
- uncontrollable hemorrhage, trauma, ballon occlusion of the aorta
- Medical subject headings
- Accidental Injuries, Wounds and Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
all cause mortality
Measured: 30 days
Occurrence of complications
Complications due to ballon occlusion of the aorta
Measured: 30 days
Blood products
Used blood products
Measured: initial resuscitation phase (day one after admission)
Secondary outcomes (1)
hemodynamic improvement (blood pressure)
hemodynamic improvement after ballon occlusion of the aorta (blood pressure)
Measured: initial resuscitation phase (day one after admission)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start28 Jun 2023
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Why it stopped: change of study plan
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-compressible Torso HemorrhageStudies 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
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gabriel Honnef, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05941572
- Sponsor's protocol ID
- 35-345 ex 22/23
- Status last verified
- Sep 2023
- First submitted
- 4 Jul 2023
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) in Patients With Major Trauma and Uncontrolled Haemorrhagic Shock: a Retrospective Analysis
- ClinicalTrials.gov ID
- NCT05941572
- Acronym / sponsor ID
- 35-345 ex 22/23
- Conditions
- Non-compressible Torso Hemorrhage, Trauma Injury
- Keywords
- uncontrollable hemorrhage, trauma, ballon occlusion of the aorta
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: change of study plan
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 28 Jun 2023 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 12 Jul 2023 (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.
Resuscitative endovascular balloon occlusion of the aorta (REBOA) is a procedure that has the goal to stabilize trauma patients with non-compressible torso hemorrhage by temporarily occluding the aorta with a ballon catheter to increase central perfusion and stop uncontrollable bleeding from the diaphragm downwards.
The investigators are planning to evaluate all patients who had a REBOA catheter placed at their clinic or in the pre-clinical setting from the start of 2019 to the 31.12.2022 who were transferred to their clinic, with basic demographic and clinical data, the procedural specifics, and their potential complications.
Detailed description
Resuscitative endovascular balloon occlusion of the aorta (REBOA) is a procedure that has the goal stabilize trauma patients with non-compressible torso hemorrhage by temporarily occluding the aorta with a ballon catheter to increase central perfusion and stop uncontrollable bleeding from the diaphragm downwards.
The investigators plan to evaluate all patients who had a REBOA catheter placed at their clinic or in the pre-clinical setting from the start of 2019 to the 31.12.2022 who were transferred to their clinic, with basic demographic and clinical data, the procedural specifics, and their potential complications.
Investigators will search for patients who had a REBOA catheter placed in the study period in the clinical documentation system (openMEDOCS) and the database of the German trauma registry. Documentation will include hemodynamic parameters, transfused blood products, complications, basic demographics and mortality up to thirty days after REBOA placement.
The investigators will then try to find patients with similar trauma mechanism and severity of trauma in the German trauma registry and match them with their REBOA patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Trauma patients with non-compressible torso hemorrhage and REBOA placement in the initial resuscitation phase.
Key inclusion criteria (3 listed)
- Patient with non-compressible torso hemorrhage following major trauma with REBOA placement
- age>18 years
- REBOA placement during the initial resuscitation
Key exclusion criteria (2 listed)
- age<18 years
- missing data
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
Mortality
Time frame: 30 days
all cause mortality
Occurrence of complications
Time frame: 30 days
Complications due to ballon occlusion of the aorta
Blood products
Time frame: initial resuscitation phase (day one after admission)
Used blood products
1 secondary outcome
hemodynamic improvement (blood pressure)
Time frame: initial resuscitation phase (day one after admission)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
Related trials for Non-compressible Torso Hemorrhage
Not yet recruitingObservational study
Abdominal Aortic Junction Tourniquet (AAJT-S) for Non-compressible Torso Haemorrhage in the Prehospital and Emergency Room Setting
Exanguination, Polytrauma
RecruitingObservational study
Abdominal Aortic Junction Tourniquet (AAJT-S) for Non-compressible Torso Haemorrhage
Exanguination, NCTH
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.
Gabriel Honnef principal investigator
Medical University of Graz
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 Non-compressible Torso Hemorrhage and Trauma Injury, 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 2 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: withdrawn, as of the sponsor's last update on 9 May 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Mortality (time frame: 30 days). The study lists 3 primary outcomes in all. 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 9 May 2025.