- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02811614
Minimally-invasive Surgery Versus Craniotomy in Patients With Supratentorial Hypertensive Intracerebral Hemorrhage (MISICH)
Minimally-invasive Surgery Versus Craniotomy in Patients With Supratentorial Hypertensive Intracerebral Hemorrhage: A Multi-center Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Hypertensive intracerebral hemorrhage (HICH) is the most common hemorrhagic stroke. The morbidity and mortality exceed 60% and only 12% patients could live independently. The choice of surgical or conservative treatment for patients with HICH is controversial.
Some minimally invasive neurosurgeries have been applied to hematoma evacuation and may improve prognosis to some extent. In endoscopic evacuation, a small burr hole is created and hematoma is removed through suction and irrigation under neuroendoscope. Endoscopic surgical evacuation promise to maximize hematoma evacuation while minimizing damage to normal tissue. Stereotactic aspiration uses image guidance to place a catheter into the main body of the hematoma and aspirate blood. It is estimated that 720 patients (240 patients in each treatment group) would provide 90% power and a type I error probability of .05 to detect an effect size of 13% with a 10% dropout rate taken into consideration. Patients will receive endoscopic evacuation, stereotactic aspiration or craniotomy according to the results of randomization. Patients will be followed up at 7 days, 30 days and 6 months.
Outcomes of different groups of patients will be collected and compared. The study is designed to find a best surgical method for hypertensive intracerebral hemorrhage.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Beijing
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Beijing, Beijing, China, 100853
- Chinese PLA General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Supratentorial hypertensive intracerebral hemorrhage on CT scan with the hematoma volume ≥25mL
- Adult patients with GCS score ≥5
- Admitted within 24h of ictus
Exclusion Criteria:
- Intracerebral hemorrhage caused by tumor, coagulopathy, aneurysm, or arteriovenous malformation
- Concurrent head injury or history of head injury
- Multiple intracerebral hemorrhage
- Known advanced demential or disability before
- With indications of terminal brain hernia
- Severe concomitant diseases that affect life expectancy
- Patients having taken anti-platelet or anticoagulant drugs for a long time
- With severe intraventricular hemorrhage
- Pregnant women
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental 1: Endoscopic Evacuation
Endoscopic hematoma evacuation with the help of a self-developed working channel.
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Endoscopic surgery for treatment of supratentorial hypertensive intracerebral hemorrhage.
Other Names:
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Experimental: Experimental 2: Stereotactic Aspiration
Place a catheter into the main body of the hematoma and aspirate blood.
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Using image guidance to aspirate hematoma.
Other Names:
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Active Comparator: Active Comparator: Craniotomy
Craniotomy with a big bone flap to for hematoma evacuation.
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Craniotomy with a big bone flap to evacuate intracerebral hematoma.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Modified Rankin Scale
Time Frame: 6 months
|
The degree of disability or dependence in the daily activities.
The scale runs from 0-6, running from perfect health without symptoms to death.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hematoma Clearance Rate
Time Frame: 24 hours and 3 days
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A ratio assessing extent of hematoma evacuation, ranging from 0 to 100%.
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24 hours and 3 days
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Operation Time
Time Frame: 24 hours
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The time from skin incision to the end of surgery.
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24 hours
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Intraoperative Blood Loss
Time Frame: 24 hours
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Volume of blood lost during operation.
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24 hours
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Postoperative Glasgow Coma Scale
Time Frame: 7 days
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A neurological scale to record the conscious state of patients at 1 week after surgery.
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7 days
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Rebleeding Rate
Time Frame: 3 days
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The percentage of patients that suffer from rebleeding after surgery.
Rebleeding usually occurs within 3 days after surgery.
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3 days
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Days of ICU Stay
Time Frame: 14 days
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The time an ICH patient has to stay in intensive care unit after surgery.
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14 days
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Mortality
Time Frame: 30 days
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The percentage of patients that die within a month after the onset of hypertensive intracerebral hemorrhage.
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30 days
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Intracranial Infection Rate
Time Frame: 7 days
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Percentage of patients that get intracranial infection.
The infection should be confirmed by cerebrospinal fluid tests.
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7 days
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Barthel Index
Time Frame: 6 months
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An ordinal scale used to measure performance of patients in activities of daily living.
A higher number is associated with a greater likelihood of being able to live at home with a degree of independence following discharge from hospital.
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6 months
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Hospitalization expenses
Time Frame: 6 months
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Total expenses during neurosurgery hospitalization
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6 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Xiaolei Chen, MD, Chinese PLA General Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- Chinese PLA General Hospital (Other Identifier: Chinese PLA General Hospital)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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