Surgical Trial in Lobar Intracerebral Haemorrhage

NCT ID: NCT01320423

Last Updated: 2011-03-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2011-08-31

Brief Summary

To establish whether a policy of earlier surgical evacuation of the haematoma in selected patients with spontaneous lobar ICH will improve outcome compared to a policy of initial conservative treatment. The trial will also help to better define the indications for early surgery.

This will overcome two of the criticisms of STICH (timing was too late and sometimes location was too deep). The subgroup identified in STICH is clinically sensible and the hypothesis identified for STICH II is in line with current neurosurgical opinion.

Detailed Description

STICH II is an international multicentre randomised parallel group trial comparing early craniotomy to evacuate the haematoma with initial conservative treatment, following spontaneous superficial intracerebral haemorrhage affecting the lobar region only. Only patients for whom the treating neurosurgeon is in equipoise about the benefits of early craniotomy compared to initial conservative treatment are eligible for the trial. Outcome is measured at six months via a postal questionnaire including the Glasgow Outcome scale, Modified Rankin Scale, EuroQol and Barthel. Six hundred patients will be recruited to the trial over thirty months. Follow-up will take six months with analysis and reporting taking one year.

Conditions

Intracerebral Haemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

surgery

Group Type: OTHER

Surgical Trial

Intervention Type: PROCEDURE

Surgical Trial in Lobar Intracerebral Haemorrhage

Interventions

Surgical Trial

Surgical Trial in Lobar Intracerebral Haemorrhage

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Evidence of a spontaneous lobar ICH on CT scan (1 cm or less from the cortex surface of the brain)
• Patient within 48 hours of ictus
• Best MOTOR score on the GCS of 5 or 6 and best EYE score on the GCS of 2 or more.
• Volume of haematoma between 10 and 100ml [Calculated using (a x b x c)/2 method]

Exclusion Criteria

• Clear evidence that the haemorrhage is due to an aneurysm or angiographically proven arteriovenous malformation.
• Intraventricular haemorrhage of any sort
• ICH secondary to tumour or trauma.
• Basal ganglia, thalamic, cerebellar or brainstem haemorrhage or extension of a lobar haemorrhage into any of these regions.
• Severe pre-existing physical or mental disability or severe co-morbidity which might interfere with assessment of outcome.
• If surgery cannot be performed within 12 hours.
• If the haematological effects of any previous anticoagulants are not completely reversed.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Medical University WanFang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Graduate Institute of Injury Prevention and Control, Taipei Medical University

Principal Investigators

Wen-Ta Chiu

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University

Locations

Taipei Medical University

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

99073

Identifier Type: -

Identifier Source: org_study_id