Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000515796
Ethics application status
Approved
Date submitted
6/05/2013
Date registered
9/05/2013
Date last updated
23/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Groin haemostasis following ablation procedures with the purse string suture.
Scientific title
A randomised controlled trial comparing the purse string suture versus manual pressure to achieve groin haemostasis for patients post ablation.
Secondary ID [1] 282460 0
Nil known
Universal Trial Number (UTN)
Trial acronym
GITAR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bleeding in the groin following cardiac ablation procedures 289072 0
Condition category
Condition code
Cardiovascular 289415 289415 0 0
Other cardiovascular diseases
Surgery 289421 289421 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a purse string suture (1.0 proline suture) tied over the femoral venous puncture site that pulls the skin and subcutaneous tissues together to achieve pressure and haemostasis. Participants will receive the intervention once following their ablation procedure by the cardiologist who performed the ablation. It will be in place for 4 hours (at which time it is cut at the skin and pulled out) and patients will be followed up for 24 hours following their procedure.
Intervention code [1] 287105 0
Treatment: Surgery
Comparator / control treatment
Manual pressure (pushing with hands) over the femoral vein. Administered by one of the cardiology nurses assisting with the procedure. This will be administered once following the ablation procedures until haemostasis is achieved (minimum of ten minutes).
Control group
Active

Outcomes
Primary outcome [1] 289520 0
Groin complications (eg. Bleeding/haematoma formation). Bleeding/haematoma will be assessed visually and with palpation and graded as bruising/haematoma <10cm or >10cm in diameter. If indicated an ultrasound may be used to look for complications such as arteriovenous fistula (very rare in this situation).
Timepoint [1] 289520 0
Following the procedure, at four hours following and at one day following the procedure. Additional reviews will be performed if ongoing bleeding occurs.
Secondary outcome [1] 302669 0
Patient discomfort in achieving groin haemostasis. Assessed by a subjective pain scale ranging from nil through to mild then moderate then severe discomfort as perceived by the patient.
Timepoint [1] 302669 0
At the time of performing the suture/manual pressure.
Secondary outcome [2] 302684 0
Time to achieve groin haemostasis. Assessed by measuring the time from suture insertion or pressure application to when bleeding and/or bruising has ceased.
Timepoint [2] 302684 0
Following the procedure and up until the point where bleeding/bruising is controlled.

Eligibility
Key inclusion criteria
Patients undergoing cardiac ablation procedures at John Hunter Hospital and Lake Macquarie Private Hospitals who require anticoagulation for the procedure. Patients undergoing ablation procedures at these hospitals who would ordinarily require the use of a size 11 French sheath in the femoral vein who may or may not also require anticoagulation.
Minimum age
15 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients unable to give informed consent.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
Assuming a haematoma rate of 10% in the control group and 5% in the purse string suture group we will need 450 patients to have 80% power for a p value of 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/05/2013
Actual
1/07/2013
Date of last participant enrolment
Anticipated
Actual
1/11/2017
Date of last data collection
Anticipated
Actual
1/11/2017
Sample size
Target
450
Accrual to date
Final
200
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 969 0
John Hunter Hospital Royal Newcastle Centre - New Lambton
Recruitment hospital [2] 970 0
Lake Macquarie Private Hospital - Gateshead

Funding & Sponsors
Funding source category [1] 287243 0
Hospital
Name [1] 287243 0
John Hunter Hospital Cardiology department
Country [1] 287243 0
Australia
Primary sponsor type
Individual
Name
Dr. Nick Jackson
Address
John Hunter Hospital Cardiology department, Lookout Road, New Lambton. NSW. 2305.
Country
Australia
Secondary sponsor category [1] 285994 0
Individual
Name [1] 285994 0
Dr. Malcolm Barlow
Address [1] 285994 0
John Hunter Hospital Cardiology department, Lookout Road, New Lambton. NSW. 2305.
Country [1] 285994 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289222 0
Hunter New England Human Research Ethics Comitee
Ethics committee address [1] 289222 0
Locked Bag No 1, New Lambton, NSW, 2305
Ethics committee country [1] 289222 0
Australia
Date submitted for ethics approval [1] 289222 0
Approval date [1] 289222 0
30/04/2013
Ethics approval number [1] 289222 0
13/04/17/5.09

Summary
Brief summary
We aim to determine whether a purse string suture to a patients groin is more or less effective than manual pressure
in preventing complications such as bleeding and bruising following ablation procedures.
We intend to randomise patients in a 1 to 1 fashion to either use of a purse string suture or manual pressure over
the femoral vein to achieve haemostasis following ablation procedures. We intend to randomise patients in this
fashion who need anticoagulation for their procedure with the
hypothesis that the purse string suture is a more efficient and more effective way to provide groin haemostasis for patients post ablation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39846 0
Dr Nick Jackson
Address 39846 0
John Hunter Hospital Cardiology department, Lookout Road, New Lambton. NSW. 2305.
Country 39846 0
Australia
Phone 39846 0
+61 2 49213000
Fax 39846 0
Email 39846 0
[email protected]
Contact person for public queries
Name 39847 0
Dr Nick Jackson
Address 39847 0
John Hunter Hospital Cardiology department, Lookout Road, New Lambton. NSW. 2305.
Country 39847 0
Australia
Phone 39847 0
+61 2 49213000
Fax 39847 0
Email 39847 0
[email protected]
Contact person for scientific queries
Name 39848 0
Dr Nick Jackson
Address 39848 0
John Hunter Hospital Cardiology department, Lookout Road, New Lambton. NSW. 2305.
Country 39848 0
Australia
Phone 39848 0
+61 2 49213000
Fax 39848 0
Email 39848 0
[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
No additional documents have been identified.