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Completed

NCT Number: NCT06312436

The AT-REBOA Target Trial

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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Key information

Conditions

Hemorrhage Cardiac Arrest Due to Trauma Multiple Trauma Pathologic Processes Pathological Conditions, Signs and Symptoms Polytrauma Shock Shock, Traumatic Wounds and Injuries

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Centre Graz, Graz, Styria, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA)

Procedure

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

Primary outcomes

  1. 30-day in-hospital mortality

    Time frame: 30 days

Secondary outcomes

  1. 3-hour mortality

    Time frame: 3 hours

  2. 6-hour mortality

    Time frame: 6 hours

  3. 24-hour mortality

    Time frame: 24 hours

  4. 90-day mortality

    Time frame: 90 days

  5. Intensive Care Unit length of stay

    Time frame: within 6 months

    days

  6. Hospital length of stay

    Time frame: within 6 months

    days

  7. Blood product use

    Time frame: 48 hours

    amount of packed red blood cells, amount of fresh frozen plasma, amount of thrombocyte concentrates

  8. Use of whole body computed tomography

    Time frame: during resuscitation care phase within 3 hours

  9. damage control procedure performed

    Time frame: during resuscitation phase within 3 hours

    operation or angioembolisation

  10. Time to damage control procedure

    Time frame: during resuscitation phase within 3 hours

    operation or angioembolisation

  11. Rate of complications

    Time frame: within 6 months

    acute kidney injury °III, use of renal replacement therapy, arterial thrombosis or embolism, limb ischaemia, vascular injury, compartment syndrome requiring fasciotomy

  12. Cause of death

    Time frame: within 6 months

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

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

Acronym: AT-REBOA

Important dates

Study start
2019
Primary completion
2023
Study completion
2024
First posted
Mar 15, 2024
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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