Clinical trial NCT02811614: Minimally-invasive Surgery Versus Craniotomy in Patients With Supratentorial Hypertensive Intracerebral Hemorrhage
Official title: Minimally-invasive Surgery Versus Craniotomy in Patients With Supratentorial Hypertensive Intracerebral Hemorrhage: A Multi-center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intracranial Hemorrhage, Hypertensive
Keywords: intracerebral hemorrhage,hypertensive
minimally invasive surgery
neuroendoscopic surgery
stereotactic aspiration
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
Collaborators: name: Jingzhou Central Hospital
name: Wuhan No.1 Hospital
name: Yichang Central People's Hospital
name: Second Hospital of Jilin University
name: The First Affiliated Hospital of Nanchang University
name: Second Affiliated Hospital of Nanchang University
name: Tang-Du Hospital
name: First Affiliated Hospital, Sun Yat-Sen University
name: Jiangmen Central Hospital
name: Jilin Province People's Hospital
name: Siping Central People's Hospital
name: Minzu Hospital of Guangxi Zhuang Autonomous Region
name: Taihe Hospital
First posted: 2016-06-23
Enrollment: 733
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Modified Rankin Scale
timeFrame: 6 months
Secondary outcomes:
measure: Hematoma Clearance Rate
timeFrame: 24 hours and 3 days
measure: Operation Time
timeFrame: 24 hours
measure: Intraoperative Blood Loss
timeFrame: 24 hours
measure: Postoperative Glasgow Coma Scale
timeFrame: 7 days
measure: Rebleeding Rate
timeFrame: 3 days
measure: Days of ICU Stay
timeFrame: 14 days
measure: Mortality
timeFrame: 30 days
measure: Intracranial Infection Rate
timeFrame: 7 days
measure: Barthel Index
timeFrame: 6 months
measure: Hospitalization expenses
timeFrame: 6 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Xiaolei Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Xu X, Zheng Y, Chen X, Li F, Zhang H, Ge X. Comparison of endoscopic evacuation, stereotactic aspiration and craniotomy for the treatment of supratentorial hypertensive intracerebral haemorrhage: study protocol for a randomised controlled trial. Trials. 2017 Jun 28;18(1):296. doi: 10.1186/s13063-017-2041-1.