ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

ACE

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Trauma

Shock

Haemorrhage

Condition category

Condition code

Surgery

Surgical techniques

Emergency medicine

Resuscitation

Injuries and Accidents

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]

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]

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]

From hospital arrival until hospital discharge.

Secondary outcome [1]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

The Alfred - Prahran

Recruitment postcode(s) [1]

3004 - Melbourne

Recruitment postcode(s) [2]

3004 - Prahran

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

The Alfred Hospital

Address [1]

55 Commercial Road
Melbourne VIC 3004

Country [1]

Australia

Primary sponsor type

Hospital

Name

The Alfred Hospital

Address

55 Commercial Road
Melbourne VIC 3004

Country

Australia

Secondary sponsor category [1]

None

Name [1]

None

Address [1]

None

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Alfred Hospital Research and Ethics Committee

Ethics committee address [1]

55 Commercial Road
Melbourne VIC 3004

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

04/07/2014

Ethics approval number [1]

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

Prof Mark Fitzgerald

Address

National Trauma Research Institute
Level 4, 89 Commercial Road
Melbourne VIC 3004

Country

Australia

Phone

+61390762000

Fax

[email protected]

Contact person for public queries

Name

Mark Fitzgerald

Address

National Trauma Research Institute
Level 4, 89 Commercial Road
Melbourne VIC 3004

Country

Australia

Phone

+61390762000

Fax

[email protected]

Contact person for scientific queries

Name

Mark Fitzgerald

Address

National Trauma Research Institute
Level 4, 89 Commercial Road
Melbourne VIC 3004

Country

Australia

Phone

+61390762000

Fax

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Feasibility study for implementation of resuscitative balloon occlusion of the aorta in peri-arrest, exsanguinating trauma at an adult level 1 Australian trauma centre.	2020	https://dx.doi.org/10.1111/1742-6723.13443

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically