Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001227886
Ethics application status
Approved
Date submitted
7/11/2012
Date registered
20/11/2012
Date last updated
20/11/2018
Date data sharing statement initially provided
20/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Renin-Angiotensin System and Other Markers in Strawberry Birthmarks in infants and young children with growing problematic haemangiomas
Scientific title
The Role of Renin-Angiotensin System and Other Markers in Haemangioma in infants and young children with growing problematic haemangiomas
Secondary ID [1] 281400 0
none
Universal Trial Number (UTN)
U1111-1135-8891
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infantile Haemangioma 287639 0
Condition category
Condition code
Skin 287973 287973 0 0
Dermatological conditions

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is an observational study aimed at comparing the effect of Propranolol, Captopril or Surgery on serum levels of components of the renin-angiotensin system (RAS) and other markers in patients with haemangioma. This will be achieved by measuring serum levels of Renin, ACE, Angiotensin II and Alpha-feto protein in participating infants and children at 4 time points. These time points are pre-treatment, after one month of treatment, after 6 months of treatment and after 1 year since start of treatment. Bloods will be taken by trained phlebotomists and/or paediatric doctors. The overall observation period is 12-14 months. This variation in overall observation period is determined by length of time on the propranolol - which in more problematic cases leads the treatment time to be up to 14 months of age - this length of time on treatment is determined by the medical doctors within the research team. In some instances, treatment is able to be stopped around 10-12 months of age, depending on the individual lesions response to treatment.
Intervention code [1] 285887 0
Not applicable
Comparator / control treatment
Propranolol (a medication for treating high blood pressure) is now used with better results. We have recently completed colelcting data from infant volunteers in a clinical trial that ran from 2010 to 2012 using Captopril treatment (another medication for treating blood pressure) for haemangioma. Our laboratory work shows a particular type of stem cell in haemangioma express components of the renin-angiotensin system (RAS) and other markers. Propranolol and Captopril target different parts of the RAS. As part of the Captopril study, blood samples were routinely taken before, during and after treatment for analysis. Those patients who undergo Propranolol treatment for haemangioma also have blood samples taken routinely, before and during treatment as part of their clinical management. There is also a sub-group of patients with haemangioma that are more effectively treated with surgery - and this sub group will be our control/comparator group. We would like to investigate the effect of these different treatments on the RAS and other markers with the hope of better understanding the biology and developing more novel and more effective and safer treatment for haemangioma.
Control group
Historical

Outcomes
Primary outcome [1] 288185 0
The primary outcome we are looking for is to compare the serial serum ACE, Angiotensin II, and Renin Levels in patients undergoing propranolol treatment for haemangioma, with those undergoing captopril and surgical treatment. These will be measured by venous blood analysis.
Timepoint [1] 288185 0
Serial measurements of RAS components at four time points. These include pre treatment, one month following start of treatment, 6 months following start of treatment and 12 months following start of treatment.
Secondary outcome [1] 299573 0
The secondary outcome we are looking for is to compare the serial serum alpha-feto protein (AFP) levels in patients undergoing propranolol treatment for haemangioma, with those undergoing captopril and surgical treatment. This will be measured by venous blood analysis. If AFP levels are outside of normal range, an abdominal ultrasound scan will be done to exclude liver abnormailities.
Timepoint [1] 299573 0
Serial measurements of AFP at four time points. These include pre treatment, one month following start of treatment, 6 months following start of treatment and 12 months following start of treatment.

Eligibility
Key inclusion criteria
1. Infants and young children aged 2 to 18 months with growing problematic haemangiomas undergoing Propranolol treatment or surgery, whose caregivers have already decided on the proposed treatment and have given written consent.
2. Non-haemangioma children aged 3 – 18 months undergoing elective surgery for whose caregiver have given written consent.
Minimum age
2 Months
Maximum age
18 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Caregivers who would not consent for the child to participate in this study.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Entered in error. This was not a clinical trial.
Date of first participant enrolment
Anticipated
5/10/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 4603 0
New Zealand
State/province [1] 4603 0

Funding & Sponsors
Funding source category [1] 286157 0
Charities/Societies/Foundations
Name [1] 286157 0
Gillies McIndoe Research Institute
Country [1] 286157 0
New Zealand
Primary sponsor type
Hospital
Name
Hutt Valley DHB
Address
Private bag 31-907
High Street
Lower Hutt 5040
New Zealand
Country
New Zealand
Secondary sponsor category [1] 284967 0
None
Name [1] 284967 0
Address [1] 284967 0
Country [1] 284967 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288215 0
Central Regional Ethics Committee
Ethics committee address [1] 288215 0
Ethics committee country [1] 288215 0
New Zealand
Date submitted for ethics approval [1] 288215 0
12/06/2012
Approval date [1] 288215 0
05/10/2012
Ethics approval number [1] 288215 0
CEN/12/06/023

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

Contacts
Principal investigator
Name 34836 0
Dr Swee Tan
Address 34836 0
Gillies McIndoe Research Institute
PO Box 7184
Newtown
Wellington 6242
New Zealand
Country 34836 0
New Zealand
Phone 34836 0
0064 4 2820366
Fax 34836 0
Email 34836 0
[email protected]
Contact person for public queries
Name 18083 0
Dr Swee Tan
Address 18083 0
Gillies McIndoe Research Institute
PO Box 7184
Newtown
Wellington 6242
Country 18083 0
New Zealand
Phone 18083 0
+64 4 5872506
Fax 18083 0
+64 4 5872510
Email 18083 0
[email protected]
Contact person for scientific queries
Name 9011 0
Swee Tan
Address 9011 0
Gillies McIndoe Research Institute
PO Box 7184
Newtown
Wellington 6242
Country 9011 0
New Zealand
Phone 9011 0
006442820366
Fax 9011 0
+64 4 5872510
Email 9011 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
Trial withdrawn


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.