HemorrhageAT-REBOANCT06312436
The AT-REBOA Target Trial
An observational study of Hemorrhage and Shock, Traumatic, run by Medical University of Graz at 2 sites in Austria.
Trial summary
Temporary aortic occlusion can limit haemorrhage, can help to maintain perfusion to the heart and brain, and may be associated with improved survival. Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) potentially provides a relatively quick means of achieving this temporary control. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Hemorrhage, Shock, Traumatic, Cardiac Arrest Due to Trauma
- What is being tested?
- Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA)
- Type of treatment
- Surgery or procedure
- How many people
- 44 participants
- Where
- 2 sitesAustria
- Study dates
- 1 Jan 2019to 20 Dec 2024
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The target trial seeks to enrol patients in the trauma room who are thought to be at imminent risk of dying from acute blood loss due to non-compressible torso or lower body haemorrhage.
Who may be able to join
- aged, or believed to be aged, 16 years or above
- confirmed or suspected life-threatening torso or lower body trauma
- thought to benefit from trauma resuscitation with REBOA
Who cannot join
- penetrating chest trauma
- known or suspected pregnancy at presentation
- prehospital thoracotomy
- severe burns injuries.
Trial locations and contacts
2 sites in 1 country.
Austria2 sites
University Medical Centre Graz
Graz, Styria, 8036
Center for Medical Data Science
Vienna, 1090
About this study
Official title: The Effectiveness of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) for Trauma Patients With Uncontrolled Haemorrhage: Study Protocol for a Target Trial and Its Emulation
Temporary aortic occlusion can limit haemorrhage, can help to maintain perfusion to the heart and brain, and may be associated with improved survival. Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) potentially provides a relatively quick means of achieving this temporary control.
In the past years, studies have tried to evaluate the benefit for this method with conflicting results. The previous UK-REBOA trial has not found any benefit in the intervention group and has even hinted at possible harm caused by the intervention. A major limitation of this study is the low number of interventions performed in participating trauma centres and the associated potentially insufficient experience with REBOA.
The aim of this study is to evaluate the effectiveness of REBOA in a setting with already experienced providers.
- Conditions
- Hemorrhage, Shock, Traumatic, Cardiac Arrest Due to Trauma, Polytrauma
- Being tested
- Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA)
- Medical subject headings
- Hemorrhage, Shock, Traumatic, Multiple Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA)Procedure or surgery
Temporary aortic occlusion can limit haemorrhage, can help to maintain perfusion to the heart and brain, and may be associated with improved survival.
| Study group | Role | What they receive |
|---|---|---|
| REBOA group | After allocation, access to a femoral artery is swiftly established by either ultrasound-guided puncture or via surgical cut-down. In parallel major haemorrhage protocol transfusion and further diagnostics are being carried out. Balloon occlusion is then achieved by placing a balloon catheter (ER-REBOA catheter, Prytime Medical®, Boerne, TX, USA) into aortic zone I (supradiaphragmatic) or III (aortic bifurcation) according to clinician decision based on injury pattern. Continuing management, including further computed tomography diagnostics and damage control interventions (operative or angioembolisation) and ongoing transfusions are undertaken according to patient status. Receives: Procedure: Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) | |
| Control group | After allocation, major haemorrhage protocol transfusion and all resuscitative measures except REBOA are performed. Continuing management, including further computed tomography diagnostics and damage control interventions (operative or angioembolisation) and ongoing transfusions are undertaken according to patient status. |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day in-hospital mortality
Measured: 30 days
Secondary outcomes (12)
3-hour mortality
Measured: 3 hours
6-hour mortality
Measured: 6 hours
24-hour mortality
Measured: 24 hours
90-day mortality
Measured: 90 days
Intensive Care Unit length of stay
days
Measured: within 6 months
Hospital length of stay
days
Measured: within 6 months
Blood product use
amount of packed red blood cells, amount of fresh frozen plasma, amount of thrombocyte concentrates
Measured: 48 hours
Use of whole body computed tomography
Measured: during resuscitation care phase within 3 hours
damage control procedure performed
operation or angioembolisation
Measured: during resuscitation phase within 3 hours
Time to damage control procedure
operation or angioembolisation
Measured: during resuscitation phase within 3 hours
Rate of complications
acute kidney injury °III, use of renal replacement therapy, arterial thrombosis or embolism, limb ischaemia, vascular injury, compartment syndrome requiring fasciotomy
Measured: within 6 months
Cause of death
Measured: within 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start1 Jan 2019
- Primary completion1 Oct 2023
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HemorrhageStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 44 participants (actual)
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
- NCT06312436
- Sponsor's protocol ID
- AT-REBOA
- Acronym
- AT-REBOA
- Status last verified
- Jan 2025
- First submitted
- 27 Feb 2024
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Stannard A, Eliason JL, Rasmussen TE. Resuscitative endovascular balloon occlusion of the aorta (REBOA) as an adjunct for hemorrhagic shock. J Trauma. 2011 Dec;71(6):1869-72. doi: 10.1097/TA.0b013e31823fe90c. No abstract available.
PubMed 22182896Jansen JO, Hudson J, Cochran C, MacLennan G, Lendrum R, Sadek S, Gillies K, Cotton S, Kennedy C, Boyers D, Ferry G, Lawrie L, Nath M, Wileman S, Forrest M, Brohi K, Harris T, Lecky F, Moran C, Morrison JJ, Norrie J, Paterson A, Tai N, Welch N, Campbell MK; UK-REBOA Study Group; Aylwin C, Bew D, Brooks A, Chinery J, Cowlam T, Frith D, George A, Hudson A, Johnstone P, Mahmood A, Novak A, O'Meara M, Reid S, Sattout A, Smith C, Stansfield T, Thompson J. Emergency Department Resuscitative Endovascular Balloon Occlusion of the Aorta in Trauma Patients With Exsanguinating Hemorrhage: The UK-REBOA Randomized Clinical Trial. JAMA. 2023 Nov 21;330(19):1862-1871. doi: 10.1001/jama.2023.20850.
PubMed 37824132Hallmann B, Honnef G, Eibinger N, Eichlseder M, Posch M, Puchwein P, Zoidl P, Zajic P. Resuscitative endovascular balloon occlusion of the aorta for trauma patients with uncontrolled hemorrhage: a retrospective target trial emulation (the AT-REBOA target trial). Eur J Emerg Med. 2025 Jun 1;32(3):202-209. doi: 10.1097/MEJ.0000000000001183. Epub 2024 Sep 24.
PubMed 39745669
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) for Trauma Patients With Uncontrolled Haemorrhage: Study Protocol for a Target Trial and Its Emulation
- ClinicalTrials.gov ID
- NCT06312436
- Acronym / sponsor ID
- AT-REBOA / AT-REBOA
- Conditions
- Hemorrhage, Shock, Traumatic, Cardiac Arrest Due to Trauma, Polytrauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 15 Mar 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.
Temporary aortic occlusion can limit haemorrhage, can help to maintain perfusion to the heart and brain, and may be associated with improved survival. Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) potentially provides a relatively quick means of achieving this temporary control.
In the past years, studies have tried to evaluate the benefit for this method with conflicting results. The previous UK-REBOA trial has not found any benefit in the intervention group and has even hinted at possible harm caused by the intervention. A major limitation of this study is the low number of interventions performed in participating trauma centres and the associated potentially insufficient experience with REBOA.
The aim of this study is to evaluate the effectiveness of REBOA in a setting with already experienced providers.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| REBOA group | – | Procedure: Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA)After allocation, access to a femoral artery is swiftly established by either ultrasound-guided puncture or via surgical cut-down. In parallel major haemorrhage protocol transfusion and further diagnostics are being carried out. Balloon occlusion is then achieved by placing a balloon catheter (ER-REBOA catheter, Prytime Medical®, Boerne, TX, USA) into aortic zone I (supradiaphragmatic) or III (aortic bifurcation) according to clinician decision based on injury pattern. Continuing management, including further computed tomography diagnostics and damage control interventions (operative or angioembolisation) and ongoing transfusions are undertaken according to patient status. |
| Control group | – | –After allocation, major haemorrhage protocol transfusion and all resuscitative measures except REBOA are performed. Continuing management, including further computed tomography diagnostics and damage control interventions (operative or angioembolisation) and ongoing transfusions are undertaken according to patient status. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The target trial seeks to enrol patients in the trauma room who are thought to be at imminent risk of dying from acute blood loss due to non-compressible torso or lower body haemorrhage.
Key inclusion criteria (3 listed)
- aged, or believed to be aged, 16 years or above
- confirmed or suspected life-threatening torso or lower body trauma
- thought to benefit from trauma resuscitation with REBOA
Key exclusion criteria (4 listed)
- penetrating chest trauma
- known or suspected pregnancy at presentation
- prehospital thoracotomy
- severe burns injuries.
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 |
|---|---|---|
| Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA)Temporary aortic occlusion can limit haemorrhage, can help to maintain perfusion to the heart and brain, and may be associated with improved survival. | Procedure or surgery | REBOA group |
Primary outcome
30-day in-hospital mortality
Time frame: 30 days
12 secondary outcomes
3-hour mortality
Time frame: 3 hours
6-hour mortality
Time frame: 6 hours
24-hour mortality
Time frame: 24 hours
90-day mortality
Time frame: 90 days
Intensive Care Unit length of stay
Time frame: within 6 months
Hospital length of stay
Time frame: within 6 months
Blood product use
Time frame: 48 hours
Use of whole body computed tomography
Time frame: during resuscitation care phase within 3 hours
damage control procedure performed
Time frame: during resuscitation phase within 3 hours
Time to damage control procedure
Time frame: during resuscitation phase within 3 hours
Rate of complications
Time frame: within 6 months
Cause of death
Time frame: within 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Background: PubMed 22182896Stannard A, Eliason JL, Rasmussen TE. Resuscitative endovascular balloon occlusion of the aorta (REBOA) as an adjunct for hemorrhagic shock. J Trauma. 2011 Dec;71(6):1869-72. doi: 10.1097/TA.0b013e31823fe90c. No abstract available.
- Background: PubMed 37824132Jansen JO, Hudson J, Cochran C, MacLennan G, Lendrum R, Sadek S, Gillies K, Cotton S, Kennedy C, Boyers D, Ferry G, Lawrie L, Nath M, Wileman S, Forrest M, Brohi K, Harris T, Lecky F, Moran C, Morrison JJ, Norrie J, Paterson A, Tai N, Welch N, Campbell MK; UK-REBOA Study Group; Aylwin C, Bew D, Brooks A, Chinery J, Cowlam T, Frith D, George A, Hudson A, Johnstone P, Mahmood A, Novak A, O'Meara M, Reid S, Sattout A, Smith C, Stansfield T, Thompson J. Emergency Department Resuscitative Endovascular Balloon Occlusion of the Aorta in Trauma Patients With Exsanguinating Hemorrhage: The UK-REBOA Randomized Clinical Trial. JAMA. 2023 Nov 21;330(19):1862-1871. doi: 10.1001/jama.2023.20850.
- Derived from this study: PubMed 39745669Hallmann B, Honnef G, Eibinger N, Eichlseder M, Posch M, Puchwein P, Zoidl P, Zajic P. Resuscitative endovascular balloon occlusion of the aorta for trauma patients with uncontrolled hemorrhage: a retrospective target trial emulation (the AT-REBOA target trial). Eur J Emerg Med. 2025 Jun 1;32(3):202-209. doi: 10.1097/MEJ.0000000000001183. Epub 2024 Sep 24.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemorrhage and Shock, Traumatic, run by Medical University of Graz at 2 sites 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 4 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: finished, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
30-day in-hospital mortality (time frame: 30 days). 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 NCT06312436, which also lists 3 linked publications.
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 22 Jan 2025.