Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001079932
Ethics application status
Approved
Date submitted
19/08/2020
Date registered
20/10/2020
Date last updated
20/10/2020
Date data sharing statement initially provided
20/10/2020
Date results information initially provided
20/10/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Open vs ultrasound guided insertion of central venous lines in children
Scientific title
Safety and efficacy of Open vs Ultrasound guided tunnelled central venous access in children- A randomised controlled trial
Secondary ID [1] 302075 0
Nil known
Universal Trial Number (UTN)
U1111-1257-1772
Trial acronym
CVLRCT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total parenteral nutrition 318672 0
Chemotherapy 318677 0
factor replacement 318678 0
Antibiotic therapy 318679 0
Insertion of surgical central lines 319131 0
Condition category
Condition code
Cancer 316691 316691 0 0
Any cancer
Infection 316692 316692 0 0
Other infectious diseases
Surgery 316693 316693 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ultrasound guided percutaneous insertion of surgical central lines inserted for parenteral nutrition (TPN), chemotherapy, antibiotic therapy and replacement of haematological factors in children. The procedure will be performed by surgeons. Time taken for the procedure will be recorded. Adherence to protocol will monitored by audit of the operating notes.
Intervention code [1] 318372 0
Treatment: Surgery
Comparator / control treatment
Open cut down insertion of surgically inserted central lines for the purpose of total parenteral nutrition, chemotherapy, antibiotic therapy and replacement of factors. Open insertion will be performed by surgeons and procedure time will be documented.
Control group
Active

Outcomes
Primary outcome [1] 324821 0
Incidence of complications as documented in medical records at the time of surgery and during course of treatment
Timepoint [1] 324821 0
At the end of two years from insertion of line or at the time of removal of line whichever was earlier
Secondary outcome [1] 385847 0
Time taken for procedure from medical records
Timepoint [1] 385847 0
At time of surgery
Secondary outcome [2] 385848 0
Complications at surgery as recorded in medical records
Timepoint [2] 385848 0
At the end of surgical procedure
Secondary outcome [3] 385849 0
Non-elective removal of line documented in medical records
Timepoint [3] 385849 0
At the time of removal of central line
Secondary outcome [4] 385850 0
Total duration of line use calculated from medical records
Timepoint [4] 385850 0
At the end of two years or at the time of removal of line

Eligibility
Key inclusion criteria
All children >0 to 16 years referred for insertion of Hickman’s or Implantable vascular access device for total parenteral nutrition, chemotherapy or replacement therapy will be included in the study. The study will be performed at The Children’s Hospital at Westmead. Ultrasound guided access will be the study group compared to the control group of open cut down insertion
Minimum age
1 Days
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Patients with loss of both internal jugular veins from prior catheter insertion will be excluded.
2. Children with vascular access into veins other than internal jugular vein.

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 was by computer generated randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated
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/efficacy
Statistical methods / analysis
Basic descriptive statistics will be used to describe all outcomes in each treatment group and overall, and treatment effects will be presented as odds ratios or differences in means with associated 95% confidence intervals. All analyses will be performed according to the intention-to-treat principle using a two-sided significance level of 0.05. Categorical outcomes will be compared between treatments using chi-square tests, continuous outcomes will be compared between treatments using t-test or non-parametric methods. Linear or logistic regression analysis will be employed to explore the impact of other prognostic variables on the association between randomised treatment and outcomes

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
4/06/2013
Date of last participant enrolment
Anticipated
Actual
6/11/2017
Date of last data collection
Anticipated
Actual
11/11/2019
Sample size
Target
300
Accrual to date
Final
109
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 17280 0
The Children's Hospital at Westmead - Westmead
Recruitment postcode(s) [1] 30997 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 306493 0
Self funded/Unfunded
Name [1] 306493 0
Not applicable
Country [1] 306493 0
Primary sponsor type
Hospital
Name
The Children's Hospital at Westmead, NSW
Address
Department of Surgery,
The Children's Hospital at Westmead,
Locked bag 4001,
Sydney, NSW 2145
Country
Australia
Secondary sponsor category [1] 307018 0
None
Name [1] 307018 0
Address [1] 307018 0
Country [1] 307018 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306699 0
Sydney Children's Hospital Network Human Research ethcis committee
Ethics committee address [1] 306699 0
The Children's Hospital at Westmead,
Westmead,
NSW 2145
Ethics committee country [1] 306699 0
Australia
Date submitted for ethics approval [1] 306699 0
04/04/2012
Approval date [1] 306699 0
30/11/2012
Ethics approval number [1] 306699 0
HREC/12/SCHN/156

Summary
Brief summary
The study is about comparing two techniques of inserting central venous lines and ports. These are special catheters inserted into a large vein in the neck for the purpose of administration of parenteral nutrition, chemotherapy or administration of other medications. Traditionally, this is performed by open surgery through a cut in the neck to expose the vein. The catheter is tunnelled from the chest up into the neck and inserted into the vein.
This will be compared with ultrasound guided insertion. Using ultrasound the vein is identified and a needle inserted into the vein and then a wire threaded through. The tract will be dilated and the catheter passed through a sheath. This is an established technique of central vein access and we have used this at this Hospital for over 3 years now. Safety of this technique is now well established at our Hospital and internationally. There are no prospective studies comparing these two techniques.
In children requiring long term treatment, infection and clotting of the vein may happen necessitating change of line and at times there is difficulty with access. We are comparing the two techniques to identify which of these is associated with lesser complications and loss of vein in the long term.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104714 0
Dr Soundappan Soundappan, SANNAPPA VENKATRAMAN
Address 104714 0
Department of Surgery,
The Children's Hospital at Westmead,
Locked bag 4001,
Westmead, NSW 2145
Country 104714 0
Australia
Phone 104714 0
+61298453341
Fax 104714 0
+61298453346
Email 104714 0
[email protected]
Contact person for public queries
Name 104715 0
Dr Soundappan Soundappan, SANNAPPA VENKATRAMAN
Address 104715 0
Department of Surgery,
The Children's Hospital at Westmead,
Locked bag 4001,
Westmead, NSW 2145
Country 104715 0
Australia
Phone 104715 0
+61298453341
Fax 104715 0
+61298453346
Email 104715 0
[email protected]
Contact person for scientific queries
Name 104716 0
Dr Soundappan Soundappan, SANNAPPA VENKATRAMAN
Address 104716 0
Department of Surgery,
The Children's Hospital at Westmead,
Locked bag 4001,
Westmead, NSW 2145
Country 104716 0
Australia
Phone 104716 0
+61298453341
Fax 104716 0
+61298453346
Email 104716 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8837Study protocol    380414-(Uploaded-21-09-2020-10-07-11)-Study-related document.docx
8838Statistical analysis plan    380414-(Uploaded-21-09-2020-10-07-41)-Study-related document.docx
8839Informed consent form    380414-(Uploaded-21-09-2020-10-09-47)-Study-related document.doc
8840Ethical approval    380414-(Uploaded-21-09-2020-10-15-56)-Study-related document.pdf



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.