Minimally-invasive Surgery Versus Craniotomy in Patients With Supratentorial Hypertensive Intracerebral Hemorrhage

Study Overview
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Brief Summary
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The effectiveness of craniotomy in the treatment of intracerebral hemorrhage remains controversial. Two main types of minimally invasive surgery, endoscopic evacuation and stereotactic aspiration, have been attempted for hematoma removal and show some advantages. However, prospective and controlled studies are still lacking. This is a multi-center randomized controlled trial designed to determine whether minimally invasive hematoma evacuation with endoscopic or stereotactic aspiration will improve the outcome in patients with hypertensive intracerebral hemorrhage compared with small-boneflap craniotomy. Patients will be randomly assigned to endoscopy group, stereotactic aspiration group or small-boneflap craniotomy group in a 1:1:1 ratio.

Detailed Description
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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.

Official Title
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Minimally-invasive Surgery Versus Craniotomy in Patients With Supratentorial Hypertensive Intracerebral Hemorrhage: A Multi-center Randomized Controlled Trial

Conditions
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Intracranial Hemorrhage, Hypertensive

Intervention / Treatment
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* Procedure: Endoscopic Evacuation
* Procedure: Stereotactic Aspiration
* Procedure: Craniotomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental 1: Endoscopic Evacuation<br>Endoscopic hematoma evacuation with the help of a self-developed working channel. | Procedure: Endoscopic Evacuation<br>* Endoscopic surgery for treatment of supratentorial hypertensive intracerebral hemorrhage.<br>* Other names: neuroendoscopic surgery;|
| Experimental: Experimental 2: Stereotactic Aspiration<br>Place a catheter into the main body of the hematoma and aspirate blood. | Procedure: Stereotactic Aspiration<br>* Using image guidance to aspirate hematoma.<br>* Other names: Hematoma Stereotactic Aspiration;|
| Active Comparator: Active Comparator: Craniotomy<br>Craniotomy with a big bone flap to for hematoma evacuation. | Procedure: Craniotomy<br>* Craniotomy with a big bone flap to evacuate intracerebral hematoma.<br>* Other names: Craniotomy evacuation of hematoma;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Rankin Scale | The degree of disability or dependence in the daily activities. The scale runs from 0-6, running from perfect health without symptoms to death. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hematoma Clearance Rate | A ratio assessing extent of hematoma evacuation, ranging from 0 to 100%. | 24 hours and 3 days | 
| Operation Time | The time from skin incision to the end of surgery. | 24 hours | 
| Intraoperative Blood Loss | Volume of blood lost during operation. | 24 hours | 
| Postoperative Glasgow Coma Scale | A neurological scale to record the conscious state of patients at 1 week after surgery. | 7 days | 
| Rebleeding Rate | The percentage of patients that suffer from rebleeding after surgery. Rebleeding usually occurs within 3 days after surgery. | 3 days | 
| Days of ICU Stay | The time an ICH patient has to stay in intensive care unit after surgery. | 14 days | 
| Mortality | The percentage of patients that die within a month after the onset of hypertensive intracerebral hemorrhage. | 30 days | 
| Intracranial Infection Rate | Percentage of patients that get intracranial infection. The infection should be confirmed by cerebrospinal fluid tests. | 7 days | 
| Barthel Index | 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. | 6 months | 
| Hospitalization expenses | Total expenses during neurosurgery hospitalization | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intracerebral hemorrhage,hypertensive, minimally invasive surgery, neuroendoscopic surgery, stereotactic aspiration