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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00163774




Registration number
NCT00163774
Ethics application status
Date submitted
12/09/2005
Date registered
14/09/2005
Date last updated
19/05/2008

Titles & IDs
Public title
Intensive Monitoring of Brain Injured Patients
Scientific title
Intensive Monitoring of Brain Injured Patients; Icp Monitoring, Transcranial Doppler, Jugular Bulb Oximetry, Brain Oxygenation, Brain Temperature and Microdialysis.
Secondary ID [1] 0 0
145/02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Traumatic Brain Injury 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Brain oxygenation and microdialysis catheters

Treatment: Devices: Brain oxygenation and microdialysis catheters


Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
- Traumatic Brain Injury with a Glascow Coma Score < 9 (ie: severe head injury)

- Traumatic Brain Injury with a Glascow Coma Score > 8 with an intracranial pressure
monitor in situ and CTscan evidence of one or more of the following: Cerebral oedema
(Marshall grades III & IV), midline shift >5 mm cerebral contusion >3cm, evacuated
subdural haematoma

- Enrolled within the first 48 hours after trauma

- Aged 17- 70years
Minimum age
17 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Has had a cardiac arrest at or post the trauma scene

- Pupils are fixed bilaterally and dilated >4mm,GCS=3

- Coagulopathy sufficient to contraindicate surgery

- No chance of survival after consideration of CT and clinical findings

- Patients with lower limb/pelvic trauma excluded from Innercool monitoring only

Study design
Purpose of the study
Treatment
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)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Bayside Health
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Analysis of cerebral blood flow (CBF) and oxygenation using complementary focal and global
monitoring techniques will permit the delivery of more informed individualised and 'targeted'
therapy on the patient with severe head injury, reduce episodes of secondary brain injury and
therefore improve outcomes.

Aims

- To develop a deeper understanding of Cerebral Blood Flow and auto-regulation for TBI
patients based on the results of data collected in patients post TBI.

- To establish the basis for further multi modality clinical trials in severely brain
injured patients in the future.

- To improve understanding of the various secondary processes that continue to cause
neuronal damage after the initial injury, and therefore affect patient outcome.

- To proceed to the second phase of the study, with the introduction of algorithms for
treatment.
Trial website
https://clinicaltrials.gov/show/NCT00163774
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Thomas Kossmann, Professor
Address 0 0
The Alfred
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications