Surgical trial in lobar intracerebral haemorrhage

Not Applicable

Completed

• Conditions: Spontaneous intracerebral haemorrhage confined to the lobar region; Circulatory System; Intracerebral haemorrhage

• Registration Number: ISRCTN22153967
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Trust (UK)

Brief Summary

2011 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/21586127 protocol 2013 Results article in http://www.ncbi.nlm.nih.gov/pubmed/23726393 results 2018 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/29321340 retrospective methods analysis 2023 Other publications in https://pubmed.ncbi.nlm.nih.gov/37161757/ (added 10/05/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-10-11
• Study Completion: 2013-03-31
• Last Update Posted: 22 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 600

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
nfavourable 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 Outcome Measures

Name	Time	Method
1. Mortality<br>2. Modified Rankin Scale<br>3. Barthel's Index of Activities of daily living (BAI)<br>4. EuroQol Quality of Life Health Survey<br>5. Survival