Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000550202
Ethics application status
Approved
Date submitted
11/03/2018
Date registered
12/04/2018
Date last updated
12/04/2018
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
None
Universal Trial Number (UTN)
Trial acronym
ACE
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
Resuscitation
Injuries and Accidents 306369 306369 0 0
Other injuries and accidents

Intervention/exposure
Study type
Observational
Patient registry
False
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
Historical

Outcomes
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.

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Obstructive shock (tension pneumothorax and cardiac tamponade) treated or excluded.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Both
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
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
17/01/2015
Date of last participant enrolment
Anticipated
Actual
12/03/2016
Date of last data collection
Anticipated
Actual
1/05/2016
Sample size
Target
50
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
VIC
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
Hospital
Name [1] 298948 0
The Alfred Hospital
Country [1] 298948 0
Australia
Primary sponsor type
Hospital
Name
The Alfred Hospital
Address
55 Commercial Road
Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 298162 0
None
Name [1] 298162 0
None
Address [1] 298162 0
None
Country [1] 298162 0

Ethics approval
Ethics application status
Approved
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
Australia
Date submitted for ethics approval [1] 299885 0
Approval date [1] 299885 0
04/07/2014
Ethics approval number [1] 299885 0

Summary
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
Nil
Trial related presentations / publications
Nil
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.

Contacts
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
Australia
Phone 81866 0
+61390762000
Fax 81866 0
Email 81866 0
m.fitzgerald@alfred.org.au
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
Australia
Phone 81867 0
+61390762000
Fax 81867 0
Email 81867 0
m.fitzgerald@alfred.org.au
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
Australia
Phone 81868 0
+61390762000
Fax 81868 0
Email 81868 0
m.fitzgerald@alfred.org.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23611Study protocolMark Fitzgerald, Robbie Lendrum, Stephen Bernard, John Moloney, De Villiers Smit, Joseph Mathew, Yesul Kim, Christopher Nickson, Richard Lin, Meei Yeung, Adam Bystrzycki, Louise Niggemeyer, Simon Hendel, Biswadev Mitra. ‘A Feasibility Study for Implementation of Resuscitative Balloon Occlusion of the Aorta (REBOA) in Peri-arrest, Exsanguinating Trauma at an Adult Level 1 Australian Trauma Centre’. Emergency Medicine Australasia, December 2019. doi: 10.1111/1742-6723.13443https://onlinelibrary.wiley.com/doi/full/10.1111/1742-6723.13443 
23612Statistical analysis plan https://onlinelibrary.wiley.com/doi/full/10.1111/1742-6723.13443 
23613Clinical study reportMark Fitzgerald, Robbie Lendrum, Stephen Bernard, John Moloney, De Villiers Smit, Joseph Mathew, Yesul Kim, Christopher Nickson, Richard Lin, Meei Yeung, Adam Bystrzycki, Louise Niggemeyer, Simon Hendel, Biswadev Mitra. ‘A Feasibility Study for Implementation of Resuscitative Balloon Occlusion of the Aorta (REBOA) in Peri-arrest, Exsanguinating Trauma at an Adult Level 1 Australian Trauma Centre’. Emergency Medicine Australasia, December 2019. doi: 10.1111/1742-6723.13443https://onlinelibrary.wiley.com/doi/full/10.1111/1742-6723.13443 

Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseFeasibility study for implementation of resuscitative balloon occlusion of the aorta in peri-arrest, exsanguinating trauma at an adult level 1 Australian trauma centre.2020https://dx.doi.org/10.1111/1742-6723.13443
N.B. These documents automatically identified may not have been verified by the study sponsor.