The AT-REBOA Target Trial

Medical University of Graz

Status: Completed

Conditions: Cardiac Arrest Due to Trauma; Shock, Traumatic; Hemorrhage; Polytrauma

Treatments: Procedure: Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA)

Study type: Observational

Funder types: Other

Identifiers

NCT06312436

AT-REBOA

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

44 participants in 2 patient groups

REBOA group

Description:

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.

Treatment:

Procedure: Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA)

Control group

Description:

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.