The AT-REBOA Target Trial

NCT06312436 | Completed

• 1 other identifier: AT-REBOA
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 2

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 30-day in-hospital mortality

  30 days

Secondary Outcomes (12)

• 3-hour mortality

  3 hours

• 6-hour mortality

  6 hours

• 24-hour mortality

  24 hours

• 90-day mortality

  90 days

• Intensive Care Unit length of stay

  within 6 months

Study Arms (2)

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.

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.

Interventions

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.

REBOA group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• penetrating chest trauma
• known or suspected pregnancy at presentation
• prehospital thoracotomy
• severe burns injuries.

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (2)

University Medical Centre Graz

Graz, Styria, 8036, Austria

Location

Center for Medical Data Science

Vienna, 1090, Austria

Location

Related Publications (3)

• 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.

  PMID: 22182896 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.

  PMID: 37824132 BACKGROUND

• 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.

  PMID: 39745669 DERIVED

MeSH Terms

Conditions

Hemorrhage; Shock, Traumatic; Multiple Trauma

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 15, 2024
• Study Start: January 1, 2019
• Primary Completion: October 1, 2023
• Study Completion: December 20, 2024
• Last Updated: January 22, 2025

Record last verified: 2025-01

Locations

AU (2)