Surgical trial in lobar intracerebral haemorrhage

• Register: ISRCTN
• Last refreshed on: 22 May 2023
• Main ID: ISRCTN22153967
• Date of registration: 11/10/2006
• Prospective Registration: Yes
• Primary sponsor: Newcastle upon Tyne Hospitals NHS Trust (UK)
• Public title: Surgical trial in lobar intracerebral haemorrhage
• Scientific title: Surgical Trial in Lobar Intracerebral Haemorrhage
• Date of first enrolment: 01/01/2007
• Target sample size: 600
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN22153967
• Study type: Interventional
• Study design: International multicentre randomised parallel group trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

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

Contacts

• Name: A David Mendelow

Key inclusion & exclusion 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: 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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Spontaneous intracerebral haemorrhage confined to the lobar region
Circulatory System
Intracerebral haemorrhage

Intervention(s)

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 becomes necessary later.

In the STICH trial, 26% of patients crossed over from conservative treatment to surgery but we have little information about the reasons for crossover. This is a major problem with surgical trials and crossovers of this size are common (Fairbank et al., 2005). The aim is to have fewer crossovers in STICH II. We will collect further information about the status (GCS and focal signs) of all patients through the first 5 days of their trial progress in order to be able to monitor the change in status that leads to a change in equipoise for the treating neurosurgeon.

Primary Outcome(s)

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 Outcome(s)

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

Secondary ID(s)

MRC G0501444/NUTH 3545

Source(s) of Monetary Support

Efficacy and Mechanism Evaluation Programme

Ethics review

Status:
Approval date:
Contact:

Multi-Centre Research Ethics Committee for Scotland (Committee A), 28/08/2006, REC ref: 06/MRE00/66

Results

• Results available: Yes
• Date Completed: 31/03/2013