Status:
WITHDRAWN
Observational Study of Safety and Outcomes After Minimally Invasive Surgery for Intracerebral Hemorrhage
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborating Sponsors:
The Ottawa Hospital
Conditions:
Intracerebral Hemorrhage
Eligibility:
All Genders
18-80 years
Brief Summary
This pilot study will examine the safety and the clinical outcomes after minimally invasive surgery (using a parafascicular technique guided by diffusion-tensor imaging) for intracerebral hemorrhage i...
Detailed Description
1.1 Intracerebral hemorrhage (ICH) morbidity, mortality, and functional outcomes. ICH is the most severe form of stroke: 30-day mortality is 40%, and 80% of survivors are physically disabled. Baseline...
Eligibility Criteria
Inclusion
- Patients aged 18-80 presenting with an acute non-traumatic symptomatic supratentorial primary ICH diagnosed by CT
- Severe neurological deficit (National Institutes of Health Stroke Scale (NIHSS) ≥6);
- Symptom onset to surgery \< 24 hours (target \< 8 hours)
- Glasgow Coma Score greater than or equal to 9
- Hematoma volume \<50 millilitres
- Minimal or no ventricular extension (corresponding to 50% or less of each ventricle)
Exclusion
- Suspected secondary or traumatic ICH
- Infratentorial ICH
- Isolated intraventricular hemorrhage (IVH)
- Uncorrected coagulopathy
- Significant premorbid disability (mRS \>1)
- Hydrocephalus
- Contraindication to safe surgical procedure
Key Trial Info
Start Date :
July 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01920763
Start Date
July 1 2013
End Date
October 1 2014
Last Update
April 4 2014
Active Locations (1)
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1
The Ottawa Hospital
Ottawa, Ontario, Canada, K1Y 4E9