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

Chinese PLA General Hospital (301 Hospital)

Status: Completed

Conditions: Intracranial Hemorrhage, Hypertensive

Treatments: Procedure: Stereotactic Aspiration; Procedure: Endoscopic Evacuation; Procedure: Craniotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02811614

Chinese PLA General Hospital

Details and patient eligibility

About

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.

Full 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.

Enrollment: 733 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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733 participants in 3 patient groups

Experimental 1: Endoscopic Evacuation

Experimental group

Description:

Endoscopic hematoma evacuation with the help of a self-developed working channel.

Treatment:

Procedure: Endoscopic Evacuation

Experimental 2: Stereotactic Aspiration

Experimental group

Description:

Place a catheter into the main body of the hematoma and aspirate blood.

Treatment:

Procedure: Stereotactic Aspiration

Active Comparator: Craniotomy

Active Comparator group

Description:

Craniotomy with a big bone flap to for hematoma evacuation.

Treatment:

Procedure: Craniotomy