An observational study in Hemorrhage, Shock, Traumatic and Cardiac Arrest Due to Trauma, sponsored by Medical University of Graz. Completed at 2 sites in Austria. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2025-01-22.
Sponsored by Medical University of Graz · Observational
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.
1,383 studies on the registry are indexed under Hemorrhage; 244 are open to participants now.
This study's enrollment of 44 is below the median of 215 across 397 observational studies indexed under Hemorrhage.
Browse Hemorrhage studies →Medical University of Graz is the lead sponsor of 471 studies on the registry; 98 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
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)
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.
Temporary aortic occlusion can limit haemorrhage, can help to maintain perfusion to the heart and brain, and may be associated with improved survival.
30-day in-hospital mortality
Time frame: 30 days
3-hour mortality
Time frame: 3 hours
6-hour mortality
Time frame: 6 hours
24-hour mortality
Time frame: 24 hours
90-day mortality
Time frame: 90 days
Intensive Care Unit length of stay
days
Time frame: within 6 months
Hospital length of stay
days
Time frame: within 6 months
Blood product use
amount of packed red blood cells, amount of fresh frozen plasma, amount of thrombocyte concentrates
Time frame: 48 hours
Use of whole body computed tomography
Time frame: during resuscitation care phase within 3 hours
damage control procedure performed
operation or angioembolisation
Time frame: during resuscitation phase within 3 hours
Time to damage control procedure
operation or angioembolisation
Time frame: during resuscitation phase within 3 hours
Rate of complications
acute kidney injury °III, use of renal replacement therapy, arterial thrombosis or embolism, limb ischaemia, vascular injury, compartment syndrome requiring fasciotomy
Time frame: within 6 months
Cause of death
Time frame: within 6 months
Plan to share: Undecided
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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