Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000701527
Ethics application status
Approved
Date submitted
12/06/2015
Date registered
6/07/2015
Date last updated
31/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Growth Hormone testing after stroke (GROWTH)
Scientific title
Investigating differences in Human Growth Hormone levels between stroke survivors and the general population.
Secondary ID [1] 286902 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
GROWTH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 295316 0
Human Growth Hormone deficiency 295425 0
Condition category
Condition code
Stroke 295585 295585 0 0
Ischaemic
Metabolic and Endocrine 295679 295679 0 0
Other endocrine disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
No interventions are being tested. One-off investigation of each participant's HGH levels will be conducted by a baseline blood sample and repeated blood samples at 15 minute intervals over 75 minutes after a single injection of arginine (500mg/Kg up to a maximum dose of 30000mg) and human growth hormone releasing hormone (1microgram/Kg up to a maximum dose of 100 micrograms).
Intervention code [1] 292087 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295291 0
Determining the prevalence of human growth hormone deficiency in stroke survivor, defined as a serum HGH concentration of less than 10ng/ml assessed by the arginine/HGHRH test.
Timepoint [1] 295291 0
One time point, within 5 years of stroke.
Secondary outcome [1] 315273 0
None
Timepoint [1] 315273 0
None

Eligibility
Key inclusion criteria
Ischemic stroke within 5 years.
18 years of age or older
Modified Rankin Score (mRS) of 3 or less
Can speak reasonable English, understand instructions and
be able to complete tests and questionnaires on their own or
with minimal support
Able to give informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
pre-existing depression, dementia or other neuropsychiatric disease

stroke induced by trauma, infection or surgery

current or past drug abuse

known active malignancy, any intracranial tumor, subdural

or epidural hematoma

renal or hepatic impairment

use of benzodiazepines or antiepileptic drugs

patients on immunosuppression or known immunodeficiency state e.g. HIV

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Testing the rate of human growth hormone (HGH) deficiency in the stroke survivor population. Currently the population rate of HGH deficiency should be near zero. This is a hypothesis-generating pilot study as there were no previous data from stroke patients on which to base a sample-size calculation.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Other reasons/comments
Other reasons
Very slow recruitment and limited shelf-life of drugs required for testing precluded extending the trial.
Date of first participant enrolment
Anticipated
3/08/2015
Actual
15/03/2016
Date of last participant enrolment
Anticipated
1/07/2017
Actual
20/06/2017
Date of last data collection
Anticipated
1/07/2017
Actual
20/09/2017
Sample size
Target
60
Accrual to date
Final
13
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 3917 0
John Hunter Hospital Royal Newcastle Centre - New Lambton
Recruitment postcode(s) [1] 9830 0
2305 - New Lambton Heights

Funding & Sponsors
Funding source category [1] 291456 0
Charities/Societies/Foundations
Name [1] 291456 0
Charitable donation to the Hunter Medical Research Institute
Country [1] 291456 0
Australia
Primary sponsor type
Hospital
Name
John Hunter Hospital
Address
Locked Bag 1, Hunter Region Mail Centre, NSW 2310
Country
Australia
Secondary sponsor category [1] 290136 0
None
Name [1] 290136 0
Address [1] 290136 0
Country [1] 290136 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293006 0
Hunter New England Local Health District Research Ethics
Ethics committee address [1] 293006 0
Research Ethics and Governance Unit
Hunter New England Local Health District
Locked Bag 1
New Lambton NSW 2305
Ethics committee country [1] 293006 0
Australia
Date submitted for ethics approval [1] 293006 0
17/06/2015
Approval date [1] 293006 0
15/07/2015
Ethics approval number [1] 293006 0

Summary
Brief summary
Ischaemic stroke may affect a number of hormone pathways involving the pituitary gland in the brain, including the production of human growth hormone (HGH). Disruption of HGH production may contribute to a number of the long-term clinical symptoms experienced by stroke survivors. This study aims to investigate whether HGH deficiency is common in stroke survivors. This is a hypothesis-generating pilot study which may lead to bigger studies in the future.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58054 0
Prof Christopher Levi
Address 58054 0
Hunter Medical Research Institute
1 Kookaburra Circuit, New Lambton Heights NSW 2305
Country 58054 0
Australia
Phone 58054 0
612 40421606
Fax 58054 0
Email 58054 0
[email protected]
Contact person for public queries
Name 58055 0
Dr Andrew Bivard
Address 58055 0
Hunter Medical Research Institute
1 Kookaburra Circuit, New Lambton Heights NSW 2305
Country 58055 0
Australia
Phone 58055 0
612 40421606
Fax 58055 0
Email 58055 0
[email protected]
Contact person for scientific queries
Name 58056 0
Dr Andrew Bivard
Address 58056 0
Hunter Medical Research Institute
1 Kookaburra Circuit, New Lambton Heights NSW 2305
Country 58056 0
Australia
Phone 58056 0
612 40421606
Fax 58056 0
Email 58056 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.