Severe traumatic brain injury Injury, Occupational Diseases, Poisoning
Conditions
Interventions
Early decompressive craniectomy versus best current medical management
Sponsors
National Trauma Research Institute, The Alfred Hospital (Australia)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 15-60 years 2. First 72 hours from time of injury 3. Severe diffuse Traumatic Brain Injury defined as: 3.1. Glasgow Coma Score (GCS) 8 before intubation and DIII or DIV. CT brain scan basal cistern compression ± midline shift 4. Intracanial pressure (ICP) monitor in situ 5. 'Refractory ICP' despite best conventional management. Refractory ICP in this study will be defined as the spontaneous persistent increase in ICP despite optimal conventional ICU therapies (including intermittent external ventricular drain [EVD] venting) of >20 mm Hg for more than 15 mins (continuously or cumulative over one hour).
Exclusion criteria
Exclusion criteria: 1. Intracranial mass lesion (>3 cm diameter) and/or previous craniectomy 2. Extradural hematoma / subdural hematoma (EDH/SDH) requiring evacuation 3. EDH/SDH >0.5 cm thickness 4. Spinal cord injury 5. Penetrating brain injury 6. Arrest at scene 7. Unreactive pupils >4 mm and GCS = 3 8. Neurosurgery contraindicated 9. No chance of survival after consideration of CT and clinical findings, following Neurosurgical consultant assessment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glasgow Outcome Score (GOSE) measured 6 months after the injury. Proportion (%) of Favourable Outcomes (GOSE 5-8) is the primary outcome measure. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mean and maximum hourly ICP 2. Favourable outcomes (GOSE 5-8) at 12 months post injury 3. Mean GOSE at 6 and 12 months using ordinal logistic regression 4. Mortality - hospital, 6 months, 12 months 5. Days in intensive care unit (ICU) and hospital | — |
Countries
Australia
Outcome results
None listed