Spontaneous intracerebral haemorrhage confined to the lobar region Circulatory System Intracerebral haemorrhage
Conditions
Interventions
The trial intervention is early evacuation of the haematoma by craniotomy, combined with appropriate best medical treatment versus best medical treatment, combined with delayed evacuation only if it b
Sponsors
Newcastle upon Tyne Hospitals NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Evidence of a spontaneous lobar ICH on Computed Tomography (CT) scan (within 1 cm of the cortical surface) 2. Patient within 48 hours of ictus 3. The 'clinical uncertainty principle' is used: only patients for whom the responsible neurosurgeon is uncertain about the benefits of either treatment are eligible. These include patients with a haematoma volume of between 10 and 100 ml and a best motor score on the Glasgow Coma Score (GCS) of five or six together with some eye opening
Exclusion criteria
Exclusion criteria: 1. Clear evidence that the haemorrhage is due to an aneurysm or angiographically proven arteriovenous malformation 2. Intraventricular haemorrhage of any sort 3. ICH secondary to tumour or trauma 4. Basal ganglia, thalamic, cerebellar or brainstem haemorrhage or extension of a lobar haemorrhage into any of these regions 5. Severe pre-existing physical or mental disability or severe co-morbidity which might interfere with assessment of outcome 6. If surgery cannot be performed within 12 hours
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Unfavourable outcome will be death or severe disability, which will be defined using a prognosis-based eight-point Glasgow Outcome Scale/Modified Rankin Scale (Mendelow et al., 2003, 2005) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mortality 2. Modified Rankin Scale 3. Barthel's Index of Activities of daily living (BAI) 4. EuroQol Quality of Life Health Survey 5. Survival | — |
Countries
Armenia, Australia, China, Czech Republic, Egypt, England, Germany, Greece, Hungary, India, Italy, Japan, Latvia, Lithuania, Macedonia, Malaysia, Mexico, Nepal, Pakistan, Poland, Romania, Russian Federation, Singapore, Spain, Sri Lanka, Turkey, United Kingdom, United States of America
Outcome results
None listed