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| Name | Class |
|---|---|
| Jingzhou Central Hospital | OTHER |
| Wuhan No.1 Hospital | OTHER |
| Yichang Central People's Hospital | OTHER |
| Second Hospital of Jilin University |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental 1: Endoscopic Evacuation | Experimental | Endoscopic hematoma evacuation with the help of a self-developed working channel. |
|
| Experimental 2: Stereotactic Aspiration | Experimental | Place a catheter into the main body of the hematoma and aspirate blood. |
|
| Active Comparator: Craniotomy | Active Comparator | Craniotomy with a big bone flap to for hematoma evacuation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic Evacuation | Procedure | Endoscopic surgery for treatment of supratentorial hypertensive intracerebral hemorrhage. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Hematoma Clearance Rate | A ratio assessing extent of hematoma evacuation, ranging from 0 to 100%. | 24 hours and 3 days |
| Operation Time | The time from skin incision to the end of surgery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiaolei Chen, MD | Chinese PLA General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Beijing | Beijing Municipality | 100853 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41529871 | Derived | 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. | |
| 38867192 | Derived |
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| ID | Term |
|---|---|
| D020299 | Intracranial Hemorrhage, Hypertensive |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D003399 | Craniotomy |
| ID | Term |
|---|---|
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| 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 |
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| Stereotactic Aspiration | Procedure | Using image guidance to aspirate hematoma. |
|
|
| Craniotomy | Procedure | Craniotomy with a big bone flap to evacuate intracerebral hematoma. |
|
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| 24 hours |
| Intraoperative Blood Loss | Volume of blood lost during operation. | 24 hours |
| Postoperative Glasgow Coma Scale | A neurological scale to record the conscious state of patients at 1 week after surgery. | 7 days |
| Rebleeding Rate | The percentage of patients that suffer from rebleeding after surgery. Rebleeding usually occurs within 3 days after surgery. | 3 days |
| Days of ICU Stay | The time an ICH patient has to stay in intensive care unit after surgery. | 14 days |
| Mortality | The percentage of patients that die within a month after the onset of hypertensive intracerebral hemorrhage. | 30 days |
| Intracranial Infection Rate | Percentage of patients that get intracranial infection. The infection should be confirmed by cerebrospinal fluid tests. | 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. | 6 months |
| Hospitalization expenses | Total expenses during neurosurgery hospitalization | 6 months |
| 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. |
| 28659171 | Derived | 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. |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |