The AT-REBOA Target Trial (AT-REBOA)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hemorrhage; Polytrauma; Shock, Traumatic; Cardiac Arrest Due to Trauma
• Intervention / Treatment: Procedure: Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA)

• Study Type: Observational
• Enrollment (Actual): 44

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Center for Medical Data Science
  • Styria
    • Graz, Styria, Austria, 8036
      • University Medical Centre Graz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion criteria:

• 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

Exclusion criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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); Temporary aortic occlusion can limit haemorrhage, can help to maintain perfusion to the heart and brain, and may be associated with improved survival.
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
30-day in-hospital mortality	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
90-day mortality		90 days
3-hour mortality		3 hours
6-hour mortality		6 hours
24-hour mortality		24 hours
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

Collaborators and Investigators

• Sponsor: Medical University of Graz

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): October 1, 2023
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: February 27, 2024
• First Submitted That Met QC Criteria: March 12, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Shock; Hemorrhage; Multiple Trauma; Shock, Traumatic
• Other Study ID Numbers: AT-REBOA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No