The AT-REBOA Target Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

44 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2024-12-20

Brief Summary

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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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Detailed Description

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Conditions

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Hemorrhage Shock, Traumatic Cardiac Arrest Due to Trauma Polytrauma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA)

Intervention Type PROCEDURE

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.

No interventions assigned to this group

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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