Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000037808
Ethics application status
Approved
Date submitted
5/01/2012
Date registered
9/01/2012
Date last updated
26/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Traumatic Brain Injury or Sub Arachnoid Haemorrhage and the relationship with Optic Nerve Sheath Diameter.
Scientific title
Traumatic Brain Injury or Sub Arachnoid Haemorrhage and the relationship with Optic Nerve Sheath Diameter.
Secondary ID [1] 279667 0
Nil
Universal Trial Number (UTN)
U1111-1126-8252
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head Injury 285485 0
Condition category
Condition code
Neurological 285669 285669 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
In this study we are looking at using a rapid ultrasound procedure to the eye to look at the optic nerve sheath (ONS) diameter. The ultrasound scan involves gentle placement of an ultrasound probe on the closed eyelid of an unconscious, sedated patientThe ONS diameter will be compared with intracerebral pressure monitors and radiologist interpretation of CT scans to establish whether or not a detectable correlation exists.
Duration 18 months
Intervention code [1] 283952 0
Not applicable
Comparator / control treatment
Ultrasound procedure to the eye to look at the optic nerve sheath (ONS) diameter.
Group 1
Group name for participants in this group:Ventilated patients with traumatic brain injury or subarachnoid haemorrhage
Expected number of participants in this group: 50. Age range:>18 years
Group 2
Group name for participants in this group: Nonventilated
volunteers.Expected number of participants in this group: 30
Age range: >18
Other relevant characteristics of this participant group:
None
Why are these characteristics relevant to the aims of the project?
The optic nerve sheath measurements will be examined to find a normal diameter for the optic nerve sheath. We
can compare the brain injured patients to these numbers to see if there is a difference. By screening volunteers the study is looking to ensure that our readings are consistent with data published by other groups, and that we have a control group.
Control group
Active

Outcomes
Primary outcome [1] 286214 0
Possible Outcomes
We aim to see whether, using ultrasound, a relationship exists between optic nerve diameter and brain injury in a cohort of ICU patients. In the future we would envision a role for this procedure in routine examination of injured patients, in particular in rural Australia where rapid access to expensive and bulky scanners is not always possible.

Paired t-test for comparison of brain injury group versus non-brain injured group. This will be attended a tht end of study
Timepoint [1] 286214 0
This will be attended a the end of study
Secondary outcome [1] 295396 0
Nil
Timepoint [1] 295396 0
Nil

Eligibility
Key inclusion criteria
Patient selection
There will be 2 groups of patients who present acutely with either:
1. Traumatic brain injury
2. Subarachnoid haemorrhage (Grade 3-5)
All patients will be subject to entry into the study as long as:
>18 years, no upper age exclusion
Acute presentation to Hospital
Suffering from either traumatic brain injury or subarachnoid haemmorhage that is so severe they require intubation and ventilation in Intensive Care.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No ocular trauma/pathology.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Study never commenced
Date of first participant enrolment
Anticipated
1/02/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 284448 0
Hospital
Name [1] 284448 0
Gold Coast Hospital
Country [1] 284448 0
Australia
Primary sponsor type
Individual
Name
Dr Mathew Hope
Address
108 Nerang Street
SOUTHPORT, QLD 4214
Country
Australia
Secondary sponsor category [1] 283376 0
None
Name [1] 283376 0
Address [1] 283376 0
Country [1] 283376 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286428 0
Gold Coast Health Services District Ethics Committee
Ethics committee address [1] 286428 0
108 Nerang Street, SOUTHPORT, QLD 4214
Ethics committee country [1] 286428 0
Australia
Date submitted for ethics approval [1] 286428 0
11/10/2011
Approval date [1] 286428 0
26/10/2011
Ethics approval number [1] 286428 0
11/QGC/146

Summary
Brief summary
Hypothesis
Optic nerve sheath (ONS) diameter increases with raised intracerebral pressure in patients with traumatic brain injury (1) and subarachnoid haemmorhage (2) and this is detectable in intensive care patients by a rapid ultrasound examination of the eye.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33583 0
Dr Dr Matthew Hope
Address 33583 0
GCUH
1 HOSPITAL BLVD
SOUTHPORT
QLD 4215
Country 33583 0
Australia
Phone 33583 0
0756875678
Fax 33583 0
Email 33583 0
mat_hope@hotmail.com
Contact person for public queries
Name 16830 0
A/Prof Dr Matthew Hope
Address 16830 0
108 Nerang Street
SOUTHPORT, QLD 4214
Country 16830 0
Australia
Phone 16830 0
0061-7-55198211
Fax 16830 0
Email 16830 0
mat_hope@hotmail.com
Contact person for scientific queries
Name 7758 0
Dr Dr Matthew Hope
Address 7758 0
108 Nerang Street
SOUTHPORT, QLD 4214
Country 7758 0
Australia
Phone 7758 0
0061-7-55198211
Fax 7758 0
Email 7758 0
mat_hope@hotmail.com

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
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Documents added automatically
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