Intracranial Hemorrhage, HypertensiveMISICHNCT02811614
Minimally-invasive Surgery Versus Craniotomy in Patients With Supratentorial Hypertensive Intracerebral Hemorrhage
A study testing Endoscopic Evacuation, Stereotactic Aspiration and Craniotomy in people with Intracranial Hemorrhage, Hypertensive, run by Chinese PLA General Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracranial Hemorrhage, Hypertensive
- What is being tested?
- Endoscopic Evacuation, Stereotactic Aspiration and Craniotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 733 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2016to 31 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Supratentorial hypertensive intracerebral hemorrhage on CT scan with the hematoma volume ≥25mL
- Adult patients with GCS score ≥5
- Admitted within 24h of ictus
Who cannot join
- 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
Show all 9Show fewer
- Patients having taken anti-platelet or anticoagulant drugs for a long time
- With severe intraventricular hemorrhage
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Minimally-invasive Surgery Versus Craniotomy in Patients With Supratentorial Hypertensive Intracerebral Hemorrhage: A Multi-center Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Intracranial Hemorrhage, Hypertensive
- Being tested
- Endoscopic Evacuation, Stereotactic Aspiration, Craniotomy
- Keywords
- intracerebral hemorrhage,hypertensive, minimally invasive surgery, neuroendoscopic surgery, stereotactic aspiration
- Medical subject headings
- Intracranial Hemorrhage, Hypertensive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic EvacuationProcedure or surgery
Also called neuroendoscopic surgery
Endoscopic surgery for treatment of supratentorial hypertensive intracerebral hemorrhage.
Stereotactic AspirationProcedure or surgery
Also called Hematoma Stereotactic Aspiration
Using image guidance to aspirate hematoma.
CraniotomyProcedure or surgery
Also called Craniotomy evacuation of hematoma
Craniotomy with a big bone flap to evacuate intracerebral hematoma.
| Study group | Role | What they receive |
|---|---|---|
| Experimental 1: Endoscopic Evacuation | Experimental | Endoscopic hematoma evacuation with the help of a self-developed working channel. Receives: Procedure: Endoscopic Evacuation |
| Experimental 2: Stereotactic Aspiration | Experimental | Place a catheter into the main body of the hematoma and aspirate blood. Receives: Procedure: Stereotactic Aspiration |
| Active Comparator: Craniotomy | Active comparator | Craniotomy with a big bone flap to for hematoma evacuation. Receives: Procedure: Craniotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (10)
Hematoma Clearance Rate
A ratio assessing extent of hematoma evacuation, ranging from 0 to 100%.
Measured: 24 hours and 3 days
Operation Time
The time from skin incision to the end of surgery.
Measured: 24 hours
Intraoperative Blood Loss
Volume of blood lost during operation.
Measured: 24 hours
Postoperative Glasgow Coma Scale
A neurological scale to record the conscious state of patients at 1 week after surgery.
Measured: 7 days
Rebleeding Rate
The percentage of patients that suffer from rebleeding after surgery. Rebleeding usually occurs within 3 days after surgery.
Measured: 3 days
Days of ICU Stay
The time an ICH patient has to stay in intensive care unit after surgery.
Measured: 14 days
Mortality
The percentage of patients that die within a month after the onset of hypertensive intracerebral hemorrhage.
Measured: 30 days
Intracranial Infection Rate
Percentage of patients that get intracranial infection. The infection should be confirmed by cerebrospinal fluid tests.
Measured: 7 days
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.
Measured: 6 months
Hospitalization expenses
Total expenses during neurosurgery hospitalization
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study start1 Jul 2016
- Primary completion30 Jun 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intracranial Hemorrhage, HypertensiveStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 733 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jingzhou Central Hospital, Wuhan No.1 Hospital, Yichang Central People's Hospital, Second Hospital of Jilin University, The First Affiliated Hospital of Nanchang University, Second Affiliated Hospital of Nanchang University, Tang-Du Hospital, First Affiliated Hospital, Sun Yat-Sen University, Jiangmen Central Hospital, Jilin Provincial People's Hospital, Siping Central People's Hospital, Minzu Hospital of Guangxi Zhuang Autonomous Region, Taihe Hospital
- Responsible party
- Principal investigator, Xiaolei Chen, Chinese PLA General Hospital
- Investigators
- Xiaolei Chen, MD, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02811614
- Sponsor's protocol ID
- Chinese PLA General Hospital
- Acronym
- MISICH
- Status last verified
- Feb 2023
- First submitted
- 20 Jun 2016
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
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.
PubMed 41529871Xu 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.
PubMed 38867192Xu 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.
PubMed 28659171
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally-invasive Surgery Versus Craniotomy in Patients With Supratentorial Hypertensive Intracerebral Hemorrhage: A Multi-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02811614
- Acronym / sponsor ID
- MISICH / Chinese PLA General Hospital
- Conditions
- Intracranial Hemorrhage, Hypertensive
- Keywords
- intracerebral hemorrhage,hypertensive, minimally invasive surgery, neuroendoscopic surgery, stereotactic aspiration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 733 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Collaborators
- Jingzhou Central Hospital, Wuhan No.1 Hospital, Yichang Central People's Hospital, Second Hospital of Jilin University, The First Affiliated Hospital of Nanchang University, Second Affiliated Hospital of Nanchang University, Tang-Du Hospital, First Affiliated Hospital, Sun Yat-Sen University, Jiangmen Central Hospital, Jilin Provincial People's Hospital, Siping Central People's Hospital, Minzu Hospital of Guangxi Zhuang Autonomous Region, Taihe Hospital
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 23 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental 1: Endoscopic Evacuation | Experimental | Procedure: Endoscopic EvacuationEndoscopic hematoma evacuation with the help of a self-developed working channel. |
| Experimental 2: Stereotactic Aspiration | Experimental | Procedure: Stereotactic AspirationPlace a catheter into the main body of the hematoma and aspirate blood. |
| Active Comparator: Craniotomy | Active comparator | Procedure: CraniotomyCraniotomy with a big bone flap to for hematoma evacuation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Supratentorial hypertensive intracerebral hemorrhage on CT scan with the hematoma volume ≥25mL
- Adult patients with GCS score ≥5
- Admitted within 24h of ictus
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic EvacuationAlso: neuroendoscopic surgeryEndoscopic surgery for treatment of supratentorial hypertensive intracerebral hemorrhage. | Procedure or surgery | Experimental 1: Endoscopic Evacuation |
| Stereotactic AspirationAlso: Hematoma Stereotactic AspirationUsing image guidance to aspirate hematoma. | Procedure or surgery | Experimental 2: Stereotactic Aspiration |
| CraniotomyAlso: Craniotomy evacuation of hematomaCraniotomy with a big bone flap to evacuate intracerebral hematoma. | Procedure or surgery | Active Comparator: Craniotomy |
Primary outcome
Modified Rankin Scale
Time frame: 6 months
The degree of disability or dependence in the daily activities. The scale runs from 0-6, running from perfect health without symptoms to death.
10 secondary outcomes
Hematoma Clearance Rate
Time frame: 24 hours and 3 days
Operation Time
Time frame: 24 hours
Intraoperative Blood Loss
Time frame: 24 hours
Postoperative Glasgow Coma Scale
Time frame: 7 days
Rebleeding Rate
Time frame: 3 days
Days of ICU Stay
Time frame: 14 days
Mortality
Time frame: 30 days
Intracranial Infection Rate
Time frame: 7 days
Barthel Index
Time frame: 6 months
Hospitalization expenses
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
- Derived from this study: PubMed 41529871Xu 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.
- Derived from this study: PubMed 38867192Xu 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.
- Derived from this study: PubMed 28659171Xu 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.
- Individual participant dataSharing planned: Yes
Related trials for Intracranial Hemorrhage, Hypertensive
Not yet recruitingPhase 3
Huayu Jiedu Formula (FTFY-919) Granules Versus Traditional Decoction for Acute Hypertensive Intracerebral Hemorrhage
Intracerebral Hemorrhage, Hypertension
Not yet recruiting
Efficacy and Safety of Antihypertensive Treatment With Mobile Stroke Units in Ultra-Early Intracerebral Hemorrhage
Nervous System Diseases, Cerebrovascular Disorders
Not yet recruiting
Yiqi Huayu Jiedu Therapy for Non-Surgical Supratentorial Hypertensive Intracerebral Hemorrhage
Intracranial Hemorrhage, Hypertensive
Enrolling by invitation
Comparison of Post-Craniotomy Blood Pressure Targets
Intracranial Hemorrhage, Hypertensive, Craniotomy Tumor Removal Surgery
Recruiting
Timing of Venous Thromboembolism Prophylaxis in Patients With Hypertensive Intracerebral Hemorrhage
Venous Thromboembolism, Pulmonary Embolism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaolei Chen, MD principal investigator
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic Evacuation, Stereotactic Aspiration and Craniotomy in people with Intracranial Hemorrhage, Hypertensive, run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin Scale (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02811614, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2023.