The AT-REBOA Target Trial

Completed

• Conditions: Hemorrhage; Shock, Traumatic; Cardiac Arrest Due to Trauma; Polytrauma
• Interventions: Procedure: Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA)

• Registration Number: NCT06312436
• Lead Sponsor: Medical University of Graz

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2023-10-01
• Study First Submitted: 2024-02-27
• Study First Submitted QC: 2024-03-12
• Study First Posted: 2024-03-15
• Study Completion: 2024-12-20
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-20
• Last Update Posted: 2025-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
REBOA group	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.

Primary Outcome Measures

Name	Time	Method
30-day in-hospital mortality	30 days

Secondary Outcome Measures

Name	Time	Method
Time to damage control procedure	during resuscitation phase within 3 hours	operation or angioembolisation
24-hour mortality	24 hours
90-day mortality	90 days
3-hour mortality	3 hours
6-hour mortality	6 hours
Blood product use	48 hours	amount of packed red blood cells, amount of fresh frozen plasma, amount of thrombocyte concentrates
Rate of complications	within 6 months	acute kidney injury °III, use of renal replacement therapy, arterial thrombosis or embolism, limb ischaemia, vascular injury, compartment syndrome requiring fasciotomy
Intensive Care Unit length of stay	within 6 months	days
Use of whole body computed tomography	during resuscitation care phase within 3 hours
damage control procedure performed	during resuscitation phase within 3 hours	operation or angioembolisation
Hospital length of stay	within 6 months	days
Cause of death	within 6 months

Trial Locations

Locations (2)

Center for Medical Data Science; 🇦🇹 Vienna, Austria

University Medical Centre Graz; 🇦🇹 Graz, Styria, Austria