Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000830594
Ethics application status
Approved
Date submitted
20/06/2024
Date registered
5/07/2024
Date last updated
5/07/2024
Date data sharing statement initially provided
5/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of an accelerated deflation protocol with standard practice for radial compression device following cardiac catheterisation
Scientific title
Comparison of an accelerated deflation protocol with standard practice for radial compression device following cardiac catheterisation in patients admitted for angiography and/or percutaneous coronary intervention with radial access
Secondary ID [1] 312375 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Heart Disease 334164 0
Acute Coronary Syndrome 334165 0
Condition category
Condition code
Cardiovascular 330835 330835 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cardiac catheterisation is an invasive cardiac procedure performed for diagnostic (angiography) and/or therapeutic (percutaneous coronary intervention [PCI]) purposes. Transradial approach to catheterisation is common, and bleeding from the radial artery puncture site can occur when the catheter is removed. At Fiona Stanley Hospital (FSH), pressure is applied to the site post procedure for 1-2 hours to achieve haemostasis using an inflated TR Band® that is then incrementally deflated by nursing staff before removal. .

The TR Band® is applied to the patient’s wrist in the cardiac catheter laboratory during removal of the catheter sheath by staff trained in this procedure. As per current policy at FSH, TR Band® deflation commences at 60 minutes after angiogram and 120 minutes after angioplasty. TR Band® deflation involves deflating the balloon by removing 3mls of air every 10 minutes until all air is removed and the TR Band® is completely deflated. Deflation is performed by nurses deemed competent in this practice and who monitor bleeding and heamatoma formation during the deflation process. Adherence to the intervention will be monitored by site investigators by direct observation.
Intervention code [1] 328872 0
Treatment: Devices
Comparator / control treatment
The accelerated deflation protocols for this trial were developed following a literature review of similar studies and in discussion with senior nursing and medical cardiology staff at the site who are experts in cardiac catheterisation procedures. The accelerated protocols were agreed upon by consensus.

ANGIOGRAM
Control A - Standard deflation protocol - angiogram
* After 60mins, begin deflation 3ml each 10min until fully deflated

Intervention A -Accelerated deflation protocol - angiogram
* After 60min, deflate 50% of air in TR band
* After 15mins, deflated remaining 50% of air

PERCUTANEOUS CORONARY INTERVENTION
Control B - Standard deflation protocol - Percutaneous Coronary Intervention (PCI)
* After 120mins, begin deflation 3ml each 10min until fully deflated

Intervention B -Accelerated deflation protocol - Percutaneous Coronary intervention (PCI)
* After 90min, deflate 50% of air in TR band
* After 15mins, deflated remaining 50% of air
Control group
Active

Outcomes
Primary outcome [1] 338606 0
• The incidence of bleeding complications determined by: (a) bleeding at the site requiring intervention and/or (b) presence of haematoma
Timepoint [1] 338606 0
Commencement of deflation through to 4 hours post removal of TR Band
Secondary outcome [1] 436550 0
Total inflation time (minutes) determined by the time from TR Band® inflation to removal
Timepoint [1] 436550 0
End of deflation
Secondary outcome [2] 436551 0
Number of TR Band deflation steps
Timepoint [2] 436551 0
Control group A - at 60mins post inflation (3mls deflation), then each 10mins (3ml deflation) until fully deflated (end of deflation)
Control group B -at 120mins post inflation (3mls deflation), then each 10mins (3ml deflation) until fully deflated (end of deflation)

Intervention A - at 60mins post inflation (50% deflation), then at 15min time (remaining 50%, end of deflation)
Intervention B - at 90mins post inflation (50% deflation), then at 15min time (remaining 50%, end of deflation)
Secondary outcome [3] 436552 0
Patient comfort
Timepoint [3] 436552 0
End of deflation

Eligibility
Key inclusion criteria
Patients admitted for angiography and/or percutaneous coronary intervention with radial access
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Inability to obtain informed consent
* Procedure requiring femoral access
* Peri-procedural complications including bleeding, haematoma, difficult radial artery access
* Discretion of the treating interventional cardiologist if it's not in the patient's best interest

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created
by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
19/08/2024
Actual
Date of last participant enrolment
Anticipated
4/10/2024
Actual
Date of last data collection
Anticipated
29/12/2024
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 26713 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 42752 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 316782 0
Charities/Societies/Foundations
Name [1] 316782 0
Frances Jones Research and Education Fund
Country [1] 316782 0
Australia
Primary sponsor type
Hospital
Name
Fiona Stanley Hospital
Address
Country
Australia
Secondary sponsor category [1] 319001 0
None
Name [1] 319001 0
Address [1] 319001 0
Country [1] 319001 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315550 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 315550 0
Ethics committee country [1] 315550 0
Australia
Date submitted for ethics approval [1] 315550 0
06/05/2024
Approval date [1] 315550 0
24/05/2024
Ethics approval number [1] 315550 0
RGS0000006845

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135054 0
Mrs Narelle Read
Address 135054 0
Fiona Stanley Hospital, 11 Robin Warren Dr, Murdoch WA 6150
Country 135054 0
Australia
Phone 135054 0
+618 61521713
Fax 135054 0
Email 135054 0
[email protected]
Contact person for public queries
Name 135055 0
Narelle Read
Address 135055 0
Fiona Stanley Hospital, 11 Robin Warren Dr, Murdoch WA 6150
Country 135055 0
Australia
Phone 135055 0
+618 61521713
Fax 135055 0
Email 135055 0
[email protected]
Contact person for scientific queries
Name 135056 0
Carrie Janerka
Address 135056 0
Fiona Stanley Hospital, 11 Robin Warren Dr, Murdoch WA 6150
Country 135056 0
Australia
Phone 135056 0
+618 6511205
Fax 135056 0
Email 135056 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.