Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000489998
Ethics application status
Approved
Date submitted
2/05/2011
Date registered
10/05/2011
Date last updated
8/03/2021
Date data sharing statement initially provided
8/03/2021
Date results information initially provided
8/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Using ultrasound guided access to radial and femoral arteries to reduce bleeding in patients undergoing coronary angiography or angioplasty
Scientific title
A comparison of transradial versus transfemoral and standard versus ultrasound-guided approaches in reducing bleeding rates in patients undergoing coronary angiography or angioplasty.
Secondary ID [1] 260114 0
Nil
Universal Trial Number (UTN)
Trial acronym
SURF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vascular complications 265762 0
Coronary angiography 265763 0
Coronary angioplasty 265792 0
Condition category
Condition code
Cardiovascular 265914 265914 0 0
Coronary heart disease
Surgery 265943 265943 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomisation 1: Transradial approach to arterial access.
Both the femoral and the radial artery are routinely used as entry sites for coronary angiography and angioplasty. Although femoral artery access is more common, radial artery access is associated with reduced bleeding complications. The procedure may take 30minutes to 1 hour.

Randomisation 2: Ultrasound-guided access
The operator will use an ultrasound probe to guide the needle into the femoral/radial artery. The procedure may take 30minutes to 1 hour.
Intervention code [1] 264504 0
Treatment: Devices
Comparator / control treatment
Randomisation 1: Transfemoral approach to arterial acess
Both the femoral and the radial artery are routinely used as entry sites for coronary angiography and angioplasty. Femoral artery access is the most commonly used. The procedure may take 30minutes to 1 hour.

Randomisation 2: Standard approach to access.
The operator will follow standard procedure (that is, manual access without ultrasound guidance) for arterial access. The procedure may take 30minutes to 1 hour.
Control group
Active

Outcomes
Primary outcome [1] 266676 0
Major Bleeding as defined by the ACUITY TRIAL. That is:

* A reduction in haemoglobin level of at least 4g/dL without an overt bleeding source or at least 3g/dL with such a source.
* Intracranial or intraocular bleeding.
* Haemorrhage at the access site requiring intervention.
* Retroperitoneal bleed.
* Presence of a haematoma of at least 5cm in diameter.
* Reoperation for bleeding, or
* Transfusion of a blood product.
Timepoint [1] 266676 0
1 week, 30 days
Secondary outcome [1] 276172 0
Vascular complications such as pseudoaneurysm, arteriovenous fistulas, compartment syndrome or limb ischemia resulting in the need for vascular surgery. This will be assessed 1 week after the procedure by a vascular surgeon using ultrasound.

There will be a 30 day follow-up via telephone.
Timepoint [1] 276172 0
1 week, 30 days
Secondary outcome [2] 276173 0
The composite endpoint of major adverse cardiovascular events (MACE), including death, myocardial infarction, urgent target lesion revascularisation and stroke
Timepoint [2] 276173 0
1 week, 30 days
Secondary outcome [3] 276174 0
Procedural failure, this is defined as the need to access a second site due to the inability to cannulate the randomised approach.
Timepoint [3] 276174 0
At time of procedure

Eligibility
Key inclusion criteria
All patients over 18 years of age who present to the cardiac catheter lab
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Cardiogenic shock or intubated patients
2. Previous CABG
3. Negative Allen’s test
4. Known difficulties (including previous unsuccessful access) with femoral (i.e. Leriche syndrome, severe peripheral artery disease, large abdominal aortic aneurysm) or radial access (Raynaud syndrome).
5. Simultaneous right heart catherisation
6. Pregnant
7. Haemodialysis patients with an arteriovenous fistula
8. Inability to give informed consent or unable to apply with all requirements

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment using sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Our method of randomisation will include the use of opaque, sealed same-coloured envelopes. After completion of baseline evaluations and assessment of inclusion and exclusion criteria, the patient will be consented and randomized using an opaque, sealed envelope system. This will consist of a pre-arranged box containing 100 opaque, sealed same-coloured envelopes of equal numbers of radial and femoral options. After randomisation, the patient will be randomised a second time using another pre-arranged box containing 100 opaque, sealed same-coloured envelopes of equal numbers of ultrasound-guided and standard options. These envelopes will be randomly topped up. Randomisation will be defined as the time the opaque envelope is opened. An allocation number will be assigned to each qualifying patient and will allow identification of the patient throughout the study.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
1388 patients will be required to yield the power of 90% after accounting for interactions between radial and femoral and ultrasound versus none.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2011
Actual
10/11/2012
Date of last participant enrolment
Anticipated
Actual
1/11/2017
Date of last data collection
Anticipated
Actual
16/12/2017
Sample size
Target
1388
Accrual to date
Final
1388
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 18866 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 33372 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 264995 0
Self funded/Unfunded
Name [1] 264995 0
Country [1] 264995 0
Primary sponsor type
Individual
Name
Dr Phong Nguyen
Address
Cardiology Department, Liverpool Hospital, LOCKED BAG 7103, LIVERPOOL NSW 1871
Country
Australia
Secondary sponsor category [1] 264086 0
Individual
Name [1] 264086 0
A/Prof Craig Juergens
Address [1] 264086 0
Cardiology Department, Liverpool Hospital, LOCKED BAG 7103, LIVERPOOL NSW 1871
Country [1] 264086 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266948 0
Human Research Ethics Committee (Western Zone)
Ethics committee address [1] 266948 0
Locked Bag 7107
Liverpool BC
NSW 1871
Ethics committee country [1] 266948 0
Australia
Date submitted for ethics approval [1] 266948 0
28/03/2011
Approval date [1] 266948 0
13/09/2011
Ethics approval number [1] 266948 0
HREC/11/LPOOL/55

Summary
Brief summary
The purpose of this study is to determine which of two different approaches in accessing an artery, transfemoral (via the artery in the groin) or transradial (via the artery in the wrist), both of these are currently used in clinical practice, is least associated with bleeding and procedural related complications.

It will also determine whether using an ultrasound machine to guide the arterial access will reduce bleeding and other procedural related complications.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32557 0
Dr Phong Nguyen
Address 32557 0
Cardiology Department, Liverpool Hospital LOCKED BAG 7103, LIVERPOOL NSW 1871
Country 32557 0
Australia
Phone 32557 0
+61 2 8738 3000
Fax 32557 0
Email 32557 0
ndtp@optusnet.com.au
Contact person for public queries
Name 15804 0
Dr Phong Nguyen
Address 15804 0
Cardiology Department, Liverpool Hospital

LOCKED BAG 7103, LIVERPOOL NSW 1871
Country 15804 0
Australia
Phone 15804 0
+61 0434 183 144
Fax 15804 0
Email 15804 0
phong.nguyen@sswahs.nsw.gov.au
Contact person for scientific queries
Name 6732 0
Dr Phong Nguyen
Address 6732 0
Cardiology Department, Liverpool Hospital

LOCKED BAG 7103, LIVERPOOL NSW 1871
Country 6732 0
Australia
Phone 6732 0
+61 0434 183 144
Fax 6732 0
Email 6732 0
phong.nguyen@sswahs.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Trial data analysis will be published but IPD will not be shared


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes EuroIntervention 2019;15-online publish-ahead-of-p... [More Details]
Other filesNo DOI: 10.4244/EIJ-D-19-00336
Plain language summaryNo Abstract Aims: This study compared outcomes in ... [More Details]

Documents added automatically
No additional documents have been identified.