Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000598987
Ethics application status
Approved
Date submitted
3/06/2011
Date registered
9/06/2011
Date last updated
19/11/2019
Date data sharing statement initially provided
27/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prospective database for the management of venous malformations at Sydney Children's Hospital
Scientific title
Children with venous malformations who are seen at Sydney childrens hospital will have annual bloods to assess the risk of coagulopathy.
Secondary ID [1] 262306 0
HREC ref no 11/051
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous malformations 268016 0
Condition category
Condition code
Skin 268145 268145 0 0
Dermatological conditions
Blood 268185 268185 0 0
Haematological diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
patients will have annual bloods for 5 years to assess coagulopathy (Full blood count, Platelets, plasma fibrinogen, D-dimer, Von Willebrand factor ). Blood willl be taken from direct venous access.
Intervention code [1] 266700 0
Not applicable
Comparator / control treatment
nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 266893 0
Deep vein thrombosis (DVT)
This outcomes will be assessed annually through patient history and through the medical record data. DVT will be assessed using clinical imaging as appropriate for the condition.
Timepoint [1] 266893 0
Although data to date has been published, data continues to be collected until each participant reaches the age of 18 years
Secondary outcome [1] 276577 0
Patients will be asked if they have experienced and symptoms in the past 12 months including infection, bleeding, pain, poor wound healing, visual compromise, and what treatment they have had in the past 12 months including compression garments, antibiotics as prophylaxis or treatment, sclerotherapy, surgery , laser or other treatment. Their medical records will also be reviewed.
Timepoint [1] 276577 0
Data collection continues until individual is 18 years of age

Eligibility
Key inclusion criteria
Venous malformation seen at SCH Randwick
Minimum age
No limit
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
nil

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
13/04/2011
Actual
7/06/2011
Date of last participant enrolment
Anticipated
31/12/2024
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
300
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 4097 0
2031

Funding & Sponsors
Funding source category [1] 267183 0
Self funded/Unfunded
Name [1] 267183 0
Country [1] 267183 0
Australia
Primary sponsor type
Hospital
Name
Sydney Children's Hospital Randwick
Address
Sydney Children's Hospital
High Street Randwick
NSW
2031
Country
Australia
Secondary sponsor category [1] 266256 0
None
Name [1] 266256 0
Address [1] 266256 0
Country [1] 266256 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269178 0
Human research ethics committee- Northern Hospital Network
Ethics committee address [1] 269178 0
Room G71, East Wing, Edmund Blacket Building
Prince of Wales Hospital
Cnr High and Avoca streets
Randwick
NSW 2031
Ethics committee country [1] 269178 0
Australia
Date submitted for ethics approval [1] 269178 0
21/03/2011
Approval date [1] 269178 0
13/04/2011
Ethics approval number [1] 269178 0
1/11/0051

Summary
Brief summary
Prospective data collection of details of venous malformations and blood screen for coagulopathy
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32695 0
A/Prof Orli Wargon
Address 32695 0
Department of Paediatric Dermatology
Sydney Children's Hospital
High St
Randwick NSW 2031
Country 32695 0
Australia
Phone 32695 0
+61 2 93821776
Fax 32695 0
+61 2 93821787
Email 32695 0
[email protected]
Contact person for public queries
Name 15942 0
A/Prof Assoc Prof Orli Wargon
Address 15942 0
Dermatology Department
Sydney Childrens Hospital
High Street
Randwick
NSW 2031
Country 15942 0
Australia
Phone 15942 0
+61 2 93821776
Fax 15942 0
Email 15942 0
[email protected]
Contact person for scientific queries
Name 6870 0
A/Prof Assoc Prof Orli Wargon
Address 6870 0
Dermatology Department
Sydney Childrens Hospital
High Street
Randwick
NSW 2031
Country 6870 0
Australia
Phone 6870 0
+61 2 93821776
Fax 6870 0
Email 6870 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
The individual patient data will not be publicly accessible. This will avoid patient identification as it pertains to a paediatric population with uncommon diseases. It may be accessed if approved by the principal investigator.


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.