The AT-REBOA Target Trial (AT-REBOA)

January 20, 2025 updated by: Medical University of Graz

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Center for Medical Data Science
    • Styria
      • Graz, Styria, Austria, 8036
        • University Medical Centre Graz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The target trial seeks to enrol patients in the trauma room who are thought to be at imminent risk of dying from acute blood loss due to non-compressible torso or lower body haemorrhage.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Procedure: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
30-day in-hospital mortality
Time Frame: 30 days
30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
90-day mortality
Time Frame: 90 days
90 days
3-hour mortality
Time Frame: 3 hours
3 hours
6-hour mortality
Time Frame: 6 hours
6 hours
24-hour mortality
Time Frame: 24 hours
24 hours
Intensive Care Unit length of stay
Time Frame: within 6 months
days
within 6 months
Hospital length of stay
Time Frame: within 6 months
days
within 6 months
Blood product use
Time Frame: 48 hours
amount of packed red blood cells, amount of fresh frozen plasma, amount of thrombocyte concentrates
48 hours
Use of whole body computed tomography
Time Frame: during resuscitation care phase within 3 hours
during resuscitation care phase within 3 hours
damage control procedure performed
Time Frame: during resuscitation phase within 3 hours
operation or angioembolisation
during resuscitation phase within 3 hours
Time to damage control procedure
Time Frame: during resuscitation phase within 3 hours
operation or angioembolisation
during resuscitation phase within 3 hours
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
within 6 months
Cause of death
Time Frame: within 6 months
within 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of Graz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 20, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 27, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 15, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AT-REBOA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Drug Interventions

Conditions

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