Skip to content

Does inflating a balloon in the aorta (to reduce blood flow) stop severely injured adults from bleeding to death at a Level 1 Australian Trauma Centre (The ACE Study)?

Evaluating the Introduction of Resuscitative Balloon Occlusion of the Aorta (REBOA) for Control of Exsanguinating Trauma Related Haemorrhage in an Adult Level 1 Australian Trauma Centre (The ACE Study)

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12618000550202
Acronym
ACE
Enrollment
15
Registered
2018-04-12
Start date
2015-01-17
Completion date
2016-03-12
Last updated
2018-06-11

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

Conditions

None listed

Brief summary

Non-compressible torso haemorrhage is a leading cause of preventable trauma death. Although Trauma Systems have optimised access to surgery and interventional radiology for definitive haemorrhage control, a significant proportion of deaths occur before this can be achieved. Resuscitative thoracotomy with aortic compression is a means of temporary haemorrhage control. This procedure is effective in patients with a thoracic source of haemorrhage that can be directly controlled, but is invasive and has poor outcomes in those with sub-diaphragmatic haemorrhage. Temporary occlusion of the aorta with an endovascular balloon is a technique used to control haemorrhage in shocked patients with ruptured aortic aneurysms. This technique has also been described in other forms of non-compressible haemorrhage such as gastro-intestinal bleeding and post-partum haemorrhage. Resuscitative endovascular balloon occlusion of the aorta (REBOA) as an adjunct for hemorrhagic shock has recently been promoted. REBOA provides a means of temporary haemorrhage control in patients with severe non compressible haemorrhage - potentially enabling these patients to access means of definitive haemorrhage control and survive. However, the procedure requires specific technical expertise as well as integration into current models of trauma reception and resuscitation - and there are conflicting reports about whether REBOA contributes to survival. This pilot study involved the introduction of Balloon Occlusion for Aortic Control of Exsanguinating Trauma Related Haemorrhage (The ACE Study) at an Australian Adult Major Trauma Centre, to determine whether REBOA would be a feasible and effective strategy to provide temporary circulatory support to trauma patients with critical, refractory, hypovolaemic shock and hypovolaemic cardiac arrest - allowing transfer to an operating theatre for definitive haemorrhage control surgery. The primary purpose was to determine if the introduction of REBOA outcome was feasible and, if so, it would improve survival of blunt or penetrating trauma patients aged 18-60 years with exsanguinating sub-diaphragmatic haemorrhage.

Interventions

This prospective, observational, interventional study sought to determine if the introduction of REBOA at an adult Australian Adult Major Trauma Centre would improve survival for major trauma patients (aged 18-60 years, transported directly from scene with exsanguinating, sub-diaphragmatic haemorrhage and hypovolaemic shock or hypovolaemic cardiac arrest) until hospital discharge (up to 3 months).

Sponsors

The Alfred Hospital
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

• Blunt or penetrating trauma patient transported directly from scene with • Exsanguinating sub-diaphragmatic haemorrhage, • Hypovolaemic shock with a SBP < 70mmHg or agonal state/pulseless cardiac arrest with electrical activity of <10 minutes and • Non/partial responder to volume resuscitation.

Exclusion criteria

Obstructive shock (tension pneumothorax and cardiac tamponade) treated or excluded.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 19, 2026