Cardiac Arrest Due to Trauma, Hemorrhage, Polytrauma, Shock, Traumatic
Conditions
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
Study design
Eligibility
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
| Measure | Time frame |
|---|---|
| 30-day in-hospital mortality | 30 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 6-hour mortality | 6 hours | — |
| 24-hour mortality | 24 hours | — |
| 90-day mortality | 90 days | — |
| Intensive Care Unit length of stay | within 6 months | days |
| Hospital length of stay | within 6 months | days |
| 3-hour mortality | 3 hours | — |
| Use of whole body computed tomography | during resuscitation care phase within 3 hours | — |
| damage control procedure performed | during resuscitation phase within 3 hours | operation or angioembolisation |
| Time to damage control procedure | during resuscitation phase within 3 hours | operation or angioembolisation |
| Rate of complications | within 6 months | acute kidney injury °III, use of renal replacement therapy, arterial thrombosis or embolism, limb ischaemia, vascular injury, compartment syndrome requiring fasciotomy |
| Cause of death | within 6 months | — |
| Blood product use | 48 hours | amount of packed red blood cells, amount of fresh frozen plasma, amount of thrombocyte concentrates |
Countries
Austria