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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) | Procedure | Temporary aortic occlusion can limit haemorrhage, can help to maintain perfusion to the heart and brain, and may be associated with improved survival. |
| Measure | Description | Time Frame |
|---|---|---|
| 30-day in-hospital mortality | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 3-hour mortality | 3 hours | |
| 6-hour mortality | 6 hours | |
| 24-hour mortality |
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Inclusion criteria:
Exclusion criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Centre Graz | Graz | Styria | 8036 | Austria | ||
| Center for Medical Data Science |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22182896 | Background | 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. | |
| 37824132 | Background | Jansen 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. |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D012774 | Shock, Traumatic |
| D009104 | Multiple Trauma |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D014947 | Wounds and Injuries |
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| 24 hours |
| 90-day mortality | 90 days |
| Intensive Care Unit length of stay | days | within 6 months |
| Hospital length of stay | days | within 6 months |
| Blood product use | amount of packed red blood cells, amount of fresh frozen plasma, amount of thrombocyte concentrates | 48 hours |
| Use of whole body computed tomography | during resuscitation care phase within 3 hours |
| damage control procedure performed | operation or angioembolisation | during resuscitation phase within 3 hours |
| Time to damage control procedure | operation or angioembolisation | 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 | within 6 months |
| Cause of death | within 6 months |
| Vienna |
| 1090 |
| Austria |
| 39745669 | Derived | Hallmann 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. |