Status:
COMPLETED
Intensive Monitoring of Brain Injured Patients
Lead Sponsor:
Bayside Health
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
17-70 years
Phase:
NA
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 ...
Detailed Description
The ultimate aim of this study is to improve the outcome of patients with severe head injury by reducing secondary brain injury. It is hoped that this will be achieved by improving clinical management...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2005
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00163774
Start Date
November 1 2002
End Date
December 1 2005
Last Update
May 19 2008
Active Locations (1)
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1
The Alfred Hospital
Melbourne, Victoria, Australia, 3004