Surgical Trial in Lobar Intracerebral Haemorrhage

Intracerebral Haemorrhage Clinical Trial

Official title:

Surgical Trial in Lobar Intracerebral Haemorrhage

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01320423
• Other study ID #: 99073
• Status: Active, not recruiting
• Phase: N/A
• First received: March 18, 2011
• Last updated: March 18, 2011
• Start date: August 2010
• Est. completion date: August 2011

Study information

• Verified date: March 2011
• Source: Taipei Medical University WanFang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 600
• Est. completion date: August 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Haemorrhage

Intervention

Procedure:
• Surgical Trial
Surgical Trial in Lobar Intracerebral Haemorrhage

Locations

Country	Name	City	State
Taiwan	Taipei Medical University	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University WanFang Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glasgow Outcome Scale/ Modified Rankin Scale	Unfavourable outcome will be death or severe disability which will be defined using a prognosis based 8 point Glasgow Outcome Scale/ Modified Rankin Scale	six months	No