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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
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)?
Scientific title
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)
Secondary ID [1] 294303 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Trauma 307007 0
Shock 307008 0
Haemorrhage 307251 0
Condition category
Condition code
Surgery 306102 306102 0 0
Surgical techniques
Emergency medicine 306103 306103 0 0
Injuries and Accidents 306369 306369 0 0
Other injuries and accidents

Study type
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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).
Intervention code [1] 300602 0
Diagnosis / Prognosis
Comparator / control treatment
The comparator group is an historical control group of 3,526 patients treated in The Alfred Trauma Centre resuscitation area 1st Jan 2013 to 31st Dec 2013,
Control group

Primary outcome [1] 305134 0
The primary outcome is survival of blunt or penetrating trauma patients aged 18-60 years with exsanguinating sub-diaphragmatic haemorrhage as detailed in the hospital record.
Timepoint [1] 305134 0
From hospital arrival until hospital discharge.
Secondary outcome [1] 344291 0
The secondary outcome is the incidence of successful REBOA deployment in the Trauma Centre as documented by The Alfred Trauma Registry and cross-checked against the hospital record.
Timepoint [1] 344291 0
First 4 hours following hospital arrival.

Key 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.

Minimum age
18 Years
Maximum age
60 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Obstructive shock (tension pneumothorax and cardiac tamponade) treated or excluded.

Study design
Defined population
Statistical methods / analysis
Prior to the trial, the investigators were from pre-published British data informed that up to 50% of those who ultimately die from junctional haemorrhage suffer a cardiac arrest prior to or immediately after arrival in the ED.

It was determined from historical registry data that between 7 and 15 patients per year may have benefited from REBOA, with the knowledge that this group would also include those with thoracic haemorrhage and lethal head injuries. For a 50% reduction in death against an historical control (n=36) an estimated log rank sample size was n = 36. It was then anticipated the study would be completed within 18 months of commencement.

Data will be collated using Microsoft Excel and analysed using Stata V.13.1 (StataCorp© LP, College Station, Texas 77845 USA). Proportions will be expressed as a percentage. The chi-squared test will be used to assess differences between categorical variables. Two-sided p-values of <0.05 will be considered statistically significant.

Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 10370 0
The Alfred - Prahran
Recruitment postcode(s) [1] 22042 0
3004 - Melbourne
Recruitment postcode(s) [2] 22044 0
3004 - Prahran

Funding & Sponsors
Funding source category [1] 298948 0
Name [1] 298948 0
The Alfred Hospital
Address [1] 298948 0
55 Commercial Road
Melbourne VIC 3004
Country [1] 298948 0
Primary sponsor type
The Alfred Hospital
55 Commercial Road
Melbourne VIC 3004
Secondary sponsor category [1] 298162 0
Name [1] 298162 0
Address [1] 298162 0
Country [1] 298162 0

Ethics approval
Ethics application status
Ethics committee name [1] 299885 0
Alfred Hospital Research and Ethics Committee
Ethics committee address [1] 299885 0
55 Commercial Road
Melbourne VIC 3004
Ethics committee country [1] 299885 0
Date submitted for ethics approval [1] 299885 0
Approval date [1] 299885 0
Ethics approval number [1] 299885 0

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.
Trial website
Trial related presentations / publications
Public notes
The Alfred Ethics Committee approved the prospective REBOA study on 4th July 2014, allowing participant enrolment without consent using Procedural Authorisation. Provision of approval from The Alfred Innovations Committee was required before commencement of the study - along with the necessary staff training, protocols and equipment deployment.

Principal investigator
Name 81866 0
Prof Mark Fitzgerald
Address 81866 0
National Trauma Research Institute
Level 4, 89 Commercial Road
Melbourne VIC 3004
Country 81866 0
Phone 81866 0
Fax 81866 0
Email 81866 0
Contact person for public queries
Name 81867 0
Prof Mark Fitzgerald
Address 81867 0
National Trauma Research Institute
Level 4, 89 Commercial Road
Melbourne VIC 3004
Country 81867 0
Phone 81867 0
Fax 81867 0
Email 81867 0
Contact person for scientific queries
Name 81868 0
Prof Mark Fitzgerald
Address 81868 0
National Trauma Research Institute
Level 4, 89 Commercial Road
Melbourne VIC 3004
Country 81868 0
Phone 81868 0
Fax 81868 0
Email 81868 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary