Minimally-invasive Surgery Versus Craniotomy in Patients With Supratentorial Hypertensive Intracerebral Hemorrhage
MISICH
1 other identifier
interventional
733
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 20, 2016
CompletedFirst Posted
Study publicly available on registry
June 23, 2016
CompletedStudy Start
First participant enrolled
July 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2022
CompletedFebruary 22, 2023
February 1, 2023
6 years
June 20, 2016
February 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (10)
Hematoma Clearance Rate
24 hours and 3 days
Operation Time
24 hours
Intraoperative Blood Loss
24 hours
Postoperative Glasgow Coma Scale
7 days
Rebleeding Rate
3 days
- +5 more secondary outcomes
Study Arms (3)
Experimental 1: Endoscopic Evacuation
EXPERIMENTALEndoscopic hematoma evacuation with the help of a self-developed working channel.
Experimental 2: Stereotactic Aspiration
EXPERIMENTALPlace a catheter into the main body of the hematoma and aspirate blood.
Active Comparator: Craniotomy
ACTIVE COMPARATORCraniotomy with a big bone flap to for hematoma evacuation.
Interventions
Endoscopic surgery for treatment of supratentorial hypertensive intracerebral hemorrhage.
Using image guidance to aspirate hematoma.
Craniotomy with a big bone flap to evacuate intracerebral hematoma.
Eligibility Criteria
You may qualify if:
- Supratentorial hypertensive intracerebral hemorrhage on CT scan with the hematoma volume ≥25mL
- Adult patients with GCS score ≥5
- Admitted within 24h of ictus
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chinese PLA General Hospitallead
- Jingzhou Central Hospitalcollaborator
- Wuhan No.1 Hospitalcollaborator
- Yichang Central People's Hospitalcollaborator
- Second Hospital of Jilin Universitycollaborator
- The First Affiliated Hospital of Nanchang Universitycollaborator
- Second Affiliated Hospital of Nanchang Universitycollaborator
- Tang-Du Hospitalcollaborator
- First Affiliated Hospital, Sun Yat-Sen Universitycollaborator
- Jiangmen Central Hospitalcollaborator
- Jilin Province People's Hospitalcollaborator
- Siping Central People's Hospitalcollaborator
- Minzu Hospital of Guangxi Zhuang Autonomous Regioncollaborator
- Taihe Hospitalcollaborator
Study Sites (1)
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
Related Publications (3)
Xu X, Zhang J, Zhang H, Yuan Q, Wang Q, Gan Z, Luo M, Chen X. Efficacy and cost-effectiveness analysis of minimally invasive surgeries for basal ganglia hypertensive intracerebral hemorrhage. J Neurointerv Surg. 2026 Jan 13:jnis-2025-024638. doi: 10.1136/jnis-2025-024638. Online ahead of print.
PMID: 41529871DERIVEDXu 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.
PMID: 38867192DERIVEDXu 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.
PMID: 28659171DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaolei Chen, MD
Chinese PLA General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 20, 2016
First Posted
June 23, 2016
Study Start
July 1, 2016
Primary Completion
June 30, 2022
Study Completion
July 31, 2022
Last Updated
February 22, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will share