Back to resultsSurgical Trial in Lobar Intracerebral Haemorrhage
Primary Purpose
Intracerebral Haemorrhage
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Surgical Trial
Sponsored by
About this trial
This is an interventional treatment trial for Intracerebral Haemorrhage focused on measuring Intracerebral Haemorrhage
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.
Sites / Locations
- Taipei Medical University
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
surgery
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01320423
First Posted
March 18, 2011
Last Updated
March 18, 2011
Sponsor
Taipei Medical University WanFang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01320423
Brief Title
Surgical Trial in Lobar Intracerebral Haemorrhage
Official Title
Surgical Trial in Lobar Intracerebral Haemorrhage
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Unknown status
Study Start Date
August 2010 (undefined)
Primary Completion Date
April 2011 (Anticipated)
Study Completion Date
August 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Taipei Medical University WanFang Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracerebral Haemorrhage
Keywords
Intracerebral Haemorrhage
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
surgery
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Surgical Trial
Intervention Description
Surgical Trial in Lobar Intracerebral Haemorrhage
Primary Outcome Measure Information:
Title
Glasgow Outcome Scale/ Modified Rankin Scale
Description
Unfavourable outcome will be death or severe disability which will be defined using a prognosis based 8 point Glasgow Outcome Scale/ Modified Rankin Scale
Time Frame
six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen-Ta Chiu
Organizational Affiliation
Taipei Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Medical University
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Surgical Trial in Lobar Intracerebral Haemorrhage
We'll reach out to this number within 24 hrs