Randomised evaluation of surgery with craniectomie for uncontrollable elevation of intra-cranial pressure
Completed
- Conditions
- intracranial pressure evelation10029301
- Registration Number
- NL-OMON33973
- Lead Sponsor
- niversity of Cambridge
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
Inclusion Criteria
1. Patients with head injury
2. age 18-65
3. Abnormal CT
4. ICP monitoring
5. refractory ICP to standard treatment for 1-12 hours
Exclusion Criteria
Bilateral fixed and dilated pupils, bleeding diathesis, devastating injury not expected to survive for 24 hours, follow up not possible, patients treated on the Lund protocol, have recieved Barbiturates pre-randomisation, significant brain stem involvement on CT
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint will be assessment of outcome at discharge( Glasgow<br /><br>outcome Score) and 6 months( Extended Goasgow outcome Score)</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints will be:<br /><br><br /><br>a. Assessment of outcome using the SF-36 and SF-10( for children below 16<br /><br>years of age) questionnaires<br /><br>b. Assessment of ICP control<br /><br>c. Time in intensive care<br /><br>d. Time to discharge from neurosurgical unit<br /><br>e. Detailed health-economic analysis</p><br>