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The AT-REBOA Target Trial

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06312436
Acronym
AT-REBOA
Enrollment
44
Registered
2024-03-15
Start date
2019-01-01
Completion date
2024-12-20
Last updated
2025-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrest Due to Trauma, Hemorrhage, Polytrauma, Shock, Traumatic

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.

Interventions

Temporary aortic occlusion can limit haemorrhage, can help to maintain perfusion to the heart and brain, and may be associated with improved survival.

Sponsors

Medical University of Graz
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
30-day in-hospital mortality30 days

Secondary

MeasureTime frameDescription
6-hour mortality6 hours
24-hour mortality24 hours
90-day mortality90 days
Intensive Care Unit length of staywithin 6 monthsdays
Hospital length of staywithin 6 monthsdays
3-hour mortality3 hours
Use of whole body computed tomographyduring resuscitation care phase within 3 hours
damage control procedure performedduring resuscitation phase within 3 hoursoperation or angioembolisation
Time to damage control procedureduring resuscitation phase within 3 hoursoperation or angioembolisation
Rate of complicationswithin 6 monthsacute kidney injury °III, use of renal replacement therapy, arterial thrombosis or embolism, limb ischaemia, vascular injury, compartment syndrome requiring fasciotomy
Cause of deathwithin 6 months
Blood product use48 hoursamount of packed red blood cells, amount of fresh frozen plasma, amount of thrombocyte concentrates

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026