Severe traumatic brain injury Injury, Occupational Diseases, Poisoning Brain injury
Conditions
Interventions
Decompressive craniectomy (surgical procedure) versus maximal medical management (including barbiturates).
Sponsors
Addenbrooke's Hospital (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 23/05/2016: 1. Patients with head injury 2. Age 10-65 years 3. Abnormal CT scan requiring ICP monitoring with raised ICP (>25mmHg >1 – 12 hours) refractory to initial medical treatment measures 4. Patients may have had an immediate operation for a mass lesion but not a 'decompressive' craniectomy Previous inclusion criteria: 1. Patients aged 10 - 65 years, either sex 2. An abnormal computed tomography (CT) scan of the head 3. Requiring ICP monitoring with raised ICP (greater than 25 mmHg greater than 1 - 12 hours), refractory to initial medical measures 4. Patients may have an immediate operation for a mass lesion but not a decompressive craniectomy 5. Patients who are immunologically, hepatically or renally compromised can be included, but type and extent of their impairment are noted
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 23/05/2016: 1. Bilateral fixed and dilated pupils 2. Bleeding diathesis 3. Devastating injury not expected to survive for 24 hours and follow up not possible 4. Patients treated by the Lund protocol are also not eligible Previous exclusion criteria: 1. Bilateral fixed and dilated pupils 2. Bleeding diathesis 3. A devastating injury not expected to survive for 24 hours 4. Follow-up not possible 5. Unable to monitor ICP 6. Patients treated on the Lund protocol 7. Primary decompression 8. Have received barbiturates pre-randomisation 9. Brainstem involvement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 23/05/2016: Extended Glasgow Outcome Scale (GOSE) at 6 months after randomisation Previous primary outcome measures: Assessment of outcome at discharge (Glasgow Outcome Score) and 6 months (Extended Glasgow Outcome Score) | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 23/05/2016: 1. GOSE at 12 and 24 months after randomisation 2. Mortality at 6, 12 and 24 months after randomisation 3. SF-36 and SF-10 (below 16 years) questionnaires at 6, 12 and 24 months after randomisation 4. Glasgow Coma Scale (GCS) at discharge from neurosciences hospital 5. Assessment of ICP control 6. Time in intensive care 7. Time to discharge from the neurosciences hospital 8. Detailed health-economic analysis Adverse events will also be reported. Secondary outcome measures from 18/10/2012 to 23/05/2016: 1. EGOS at 12, 24 and 36 months 2. SF 36 at 6, 12 and 24 months with a health economic analysis Original secondary outcome measures until 18/10/2012: 1. Assessment of outcome using the 36-item short form (SF-36) questionnaire 2. Assessment of ICP control 3. Time in intensive care 4. Time to discharge from the neurosurgical unit | — |
Countries
Brazil, Canada, China, Czech Republic, England, Germany, Greece, Italy, Japan, Latvia, Malaysia, Peru, Russian Federation, Saudi Arabia, Singapore, Spain, Turkey, United Kingdom, United States of America
Outcome results
None listed