- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01320423
Surgical Trial in Lobar Intracerebral Haemorrhage
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Taipei, Taiwan
- Taipei Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: surgery
|
Surgical Trial in Lobar Intracerebral Haemorrhage
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glasgow Outcome Scale/ Modified Rankin Scale
Time Frame: six months
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Wen-Ta Chiu, Taipei Medical University
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 99073
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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