Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000899842
Ethics application status
Approved
Date submitted
17/08/2012
Date registered
23/08/2012
Date last updated
23/08/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Markers of Brain injury study (MOBI)
Scientific title
Markers of Brain injury study (MOBI): determining the role of neuroprostanes in traumatic brain injury
Secondary ID [1] 281069 0
EC 2008/218
Universal Trial Number (UTN)
Nil
Trial acronym
MOBI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Traumatic Brain Injury 279090 0
Condition category
Condition code
Neurological 279278 279278 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
This is a prospective observational study. All patients with a severe brain injury and intracranial pressure monitoring will be included. Blood alone ( ARM 1 ) or blood and cerebrospinal fluid ( ARM 2) will be collected on days 1, 3, 5 and 7. Arm 1 - Sampling of Plasma (patients with ICP monitoring via Codman indwelling transducer)
Arm 2 - Sampling of CSF and Plasma (patients with an external ventricular drain). Values will be compared with those from historical controls who healthy age and gender matched patients having subarachnoid anaesthesia and who have provided us wth their CSF
Intervention code [1] 283665 0
Not applicable
Comparator / control treatment
There will be a direct comparison of concentrations of these compounds in blood between the two groups. As CSF will only be collected in one group, we will use historical controls, whose data we have already published. We propose to examine changes over time of these compounds.
The control samples were taken from healthy age and gender matched patients having subarachnoid anaesthesia and who have provided us wth their CSF
Control group
Historical

Outcomes
Primary outcome [1] 279898 0
Glasgow Outcome Score- this is a measure of the qulaity of functional neurological outcome
Timepoint [1] 279898 0
6 months.
Secondary outcome [1] 294720 0
Plasma and CSF samples will be subjected to GC-MS/ HPLC analysis to determine concentrations of Isoprostanes, Isofurans and Neuroprostanes. We will use satistical methods to examine the correlation between plasma and CSF samples and their predictive utility in terms of outcome.
Timepoint [1] 294720 0
Over the period of ICP monitoring (up to and including Day 7 of admission)

Eligibility
Key inclusion criteria
Traumatic brain injury requiring Intracranial Pressure Monitoring
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unlikely to survive the first 24 hours of hospitalisation

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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
21/11/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284148 0
University
Name [1] 284148 0
Neurotrauma research program of WA institute of medical research
Country [1] 284148 0
Australia
Primary sponsor type
University
Name
Neurotrauma research program of WA institute of medical research
Address
Louise Goodes
Executive Officer
Neurotrauma Research Program
University of Western Australia
B block
Hospital avenue
Midland
Perth
6009
WA
Country
Australia
Secondary sponsor category [1] 269110 0
None
Name [1] 269110 0
Address [1] 269110 0
Country [1] 269110 0
Other collaborator category [1] 252330 0
Hospital
Name [1] 252330 0
Royal Perth Hospital Department of Anaesthesia and Pain Medicine
Address [1] 252330 0
Wellington Street
Perth
6000
WA
Country [1] 252330 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 272110 0
HREC of Royal Perth Hospital
Ethics committee address [1] 272110 0
GPO Box X2213
Perth, Western Australia, 6001
Ethics committee country [1] 272110 0
Australia
Date submitted for ethics approval [1] 272110 0
Approval date [1] 272110 0
Ethics approval number [1] 272110 0

Summary
Brief summary
Measurement of neuroprostane and isofuran levels in plasma and CSF may give prognostic information in traumatic brain injury. The study aims are: 1) To establish the correlation between plasma and CSF levels of these markers in a population of severely brain injured patients and 2) To establish correlation between neuroprostane and isofuran levels and outcome as measured by glasgow outcome score and anterograde amnesia score.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 33345 0
Address 33345 0
Country 33345 0
Phone 33345 0
Fax 33345 0
Email 33345 0
Contact person for public queries
Name 16592 0
Tomas Corcoran
Address 16592 0
Department of Anaesthesia and Pain Medicine
ROyal Perth Hospital
GPO Box X2213
Perth, Western Australia, 6001
Country 16592 0
Australia
Phone 16592 0
+61 414791151
Fax 16592 0
Email 16592 0
[email protected]
Contact person for scientific queries
Name 7520 0
Tomas Corcoran
Address 7520 0
Department of Anaesthesia and Pain Medicine
ROyal Perth Hospital
GPO Box X2213
Perth, Western Australia, 6001
Country 7520 0
Australia
Phone 7520 0
+61 414791151
Fax 7520 0
Email 7520 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.