Minimally-invasive Surgery Versus Craniotomy in Patients With Supratentorial Hypertensive Intracerebral Hemorrhage
NCT ID: NCT02811614
Last Updated: 2023-02-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
733 participants
INTERVENTIONAL
2016-07-01
2022-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparison Between Stereotactic Aspiration and Intra-endoscopic Surgery to Treat Intracerebral Hemorrhage
NCT02515903
AI-Guided Hematoma Aspiration vs. Conservative Treatment for Spontaneous ICH
NCT07077343
Efficacy and Safety of NeuroEndoscopic Surgery for Large IntraCerebral Hemorrhage
NCT06894433
Efficacy and Safety of NeuroEndoscopic Surgery for IntraCerebral Hemorrhage
NCT05539859
Modified Stereotactic Aspiration and Thrombolysis of Intracerebral Hemorrhage:a Multi-center Controlled Study
NCT00940745
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Experimental 1: Endoscopic Evacuation
Endoscopic hematoma evacuation with the help of a self-developed working channel.
Endoscopic Evacuation
Endoscopic surgery for treatment of supratentorial hypertensive intracerebral hemorrhage.
Experimental 2: Stereotactic Aspiration
Place a catheter into the main body of the hematoma and aspirate blood.
Stereotactic Aspiration
Using image guidance to aspirate hematoma.
Active Comparator: Craniotomy
Craniotomy with a big bone flap to for hematoma evacuation.
Craniotomy
Craniotomy with a big bone flap to evacuate intracerebral hematoma.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Adult patients with GCS score ≥5
* Admitted within 24h of ictus
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Jingzhou Central Hospital
OTHER
Wuhan No.1 Hospital
OTHER
Yichang Central People's Hospital
OTHER
Second Hospital of Jilin University
OTHER
The First Affiliated Hospital of Nanchang University
OTHER
Second Affiliated Hospital of Nanchang University
OTHER
Tang-Du Hospital
OTHER
First Affiliated Hospital, Sun Yat-Sen University
OTHER
Jiangmen Central Hospital
OTHER
Jilin Province People's Hospital
UNKNOWN
Siping Central People's Hospital
OTHER
Minzu Hospital of Guangxi Zhuang Autonomous Region
UNKNOWN
Taihe Hospital
OTHER
Chinese PLA General Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Xiaolei Chen
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Xiaolei Chen, MD
Role: PRINCIPAL_INVESTIGATOR
Chinese PLA General Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Xu X, Zhang H, Zhang J, Luo M, Wang Q, Zhao Y, Gan Z, Xu B, Chen X; MISICH study team. Minimally invasive surgeries for spontaneous hypertensive intracerebral hemorrhage (MISICH): a multicenter randomized controlled trial. BMC Med. 2024 Jun 13;22(1):244. doi: 10.1186/s12916-024-03468-y.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Chinese PLA General Hospital
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.