Traumatic intracerebral haemorrhage and contusion Injury, Occupational Diseases, Poisoning Intracerebral haemorrhage
Conditions
Interventions
Early surgery vs initial conservative treatment
Sponsors
Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Both males and females, adults aged 14 or over 2. Evidence of a traumatic intracerebral haemorrhage (TICH) on computed tomography (CT) with a single volume of attenuation significantly raised above that of the background white and grey matter that is in total greater than 10 ml calculated by width times height times length in cm divided by 2 3. Within 24 hours of head injury 4. Clinical equipoise: only patients for whom the responsible neurosurgeon is uncertain about the benefits of either treatment are eligible
Exclusion criteria
Exclusion criteria: 1. A significant surface haematoma (epidural haematoma [EDH] or subdural haematoma [SDH]) requiring surgery (The indications for intervention for these patients are already very well defined) 2. More than two separate haematomas fulfilling inclusion criteria 3. If surgery can not be performed within 36 hours of injury or 12 hours of randomisation (whichever is the shorter) 4. Severe pre-existing physical or mental disability or severe co-morbidity which might lead to a poor outcome even if the patient made a full recovery from the head injury (Examples would be a high level of dependence before the injury or severe irreversible associated injury such as complete spinal cord injury) 5. Permanent residence outside a study country preventing follow up 6. Patient and/or relative has a strong preference for one treatment modality
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Unfavourable outcome will be death or severe disability which will be defined using a prognosis based 8 point Glasgow Outcome Scale. Total duration of follow-up: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| The following will be assessed at 6 and 12 months: 1. Rankin scale 2. Euroqol EQ-5D 3. Mortality 4. Survival 5. Major Adverse Events (death, pulmonary embolism or deep vein thrombosis, infection, rehaemorrhage) 6. Quality-adjusted life-years (QALYs) 7. Total health care costs 8. Social costs | — |
Countries
Czech Republic, Egypt, Germany, Greece, India, Italy, Latvia, Lithuania, Macedonia, Poland, Russian Federation, Spain, United Kingdom, United States of America
Outcome results
None listed