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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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13 January 2020 |
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Main ID: |
ACTRN12615000701527 |
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Date of registration:
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06/07/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Growth Hormone testing after stroke (GROWTH)
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Scientific title:
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Investigating differences in Human Growth Hormone levels between stroke survivors and the general population. |
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Date of first enrolment:
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15/03/2016 |
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Target sample size:
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60 |
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Recruitment status: |
Stopped early |
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URL:
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https://anzctr.org.au/ACTRN12615000701527.aspx |
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Study type:
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Interventional |
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Study design:
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Purpose: Diagnosis; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety/efficacy;
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Phase:
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Not Applicable
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Countries of recruitment
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Australia
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Contacts
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Name:
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Dr Andrew Bivard
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Address:
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Hunter Medical Research Institute
1 Kookaburra Circuit, New Lambton Heights NSW 2305
Australia |
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Telephone:
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612 40421606 |
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Email:
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andrew.bivard@hotmail.com |
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Affiliation:
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Name:
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Dr Andrew Bivard
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Address:
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Hunter Medical Research Institute
1 Kookaburra Circuit, New Lambton Heights NSW 2305
Australia |
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Telephone:
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612 40421606 |
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Email:
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andrew.bivard@hotmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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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
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
Age minimum:
18 Years
Age maximum:
No limit
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Stroke;Human Growth Hormone deficiency;
Stroke
Human Growth Hormone deficiency
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Metabolic and Endocrine - Other endocrine disorders
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Stroke - Ischaemic
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Intervention(s)
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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).
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Primary Outcome(s)
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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.[One time point, within 5 years of stroke.]
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Secondary Outcome(s)
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None[None]
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Secondary ID(s)
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Nil Known
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Source(s) of Monetary Support
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Charitable donation to the Hunter Medical Research Institute
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Ethics review
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Status: Approved
Approval date:
Contact:
Hunter New England Local Health District Research Ethics
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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