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

Intracranial Hemorrhage, Hypertensive Clinical Trial

— MISICH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02811614
• Other study ID #: Chinese PLA General Hospital
• Status: Completed
• Phase: N/A
• Start date: July 1, 2016
• Est. completion date: July 31, 2022

Study information

• Verified date: February 2023
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 733
• Est. completion date: July 31, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracranial Hemorrhage, Hypertensive
• Intracranial Hemorrhages

Intervention

Procedure:
• Endoscopic Evacuation
Endoscopic surgery for treatment of supratentorial hypertensive intracerebral hemorrhage.
• Stereotactic Aspiration
Using image guidance to aspirate hematoma.
• Craniotomy
Craniotomy with a big bone flap to evacuate intracerebral hematoma.

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (14)

Lead Sponsor

Collaborator

Chinese PLA General Hospital

First Affiliated Hospital, Sun Yat-Sen University, Jiangmen Central Hospital, Jilin Province People's Hospital, Jingzhou Central Hospital, Minzu Hospital of Guangxi Zhuang Autonomous Region, Second Affiliated Hospital of Nanchang University, Second Hospital of Jilin University, Siping Central Hospital, Taihe Hospital, Tang-Du Hospital, The First Affiliated Hospital of Nanchang University, Wuhan No.1 Hospital, Yichang Central People's Hospital

Country where clinical trial is conducted

China, 

Outcome

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