Minimally-invasive Surgery Versus Craniotomy in Patients With Supratentorial Hypertensive Intracerebral Hemorrhage (MISICH)
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|ClinicalTrials.gov Identifier: NCT02811614|
Recruitment Status : Recruiting
First Posted : June 23, 2016
Last Update Posted : July 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Intracranial Hemorrhage, Hypertensive||Procedure: Endoscopic Evacuation Procedure: Stereotactic Aspiration Procedure: Craniotomy||Not Applicable|
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. In this study, about 900 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||900 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Minimally-invasive Surgery Versus Craniotomy in Patients With Supratentorial Hypertensive Intracerebral Hemorrhage: A Multi-center Randomized Controlled Trial|
|Actual Study Start Date :||August 1, 2016|
|Estimated Primary Completion Date :||June 30, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Experimental: Experimental 1: Endoscopic Evacuation
Endoscopic hematoma evacuation with the help of a self-developed working channel.
Procedure: Endoscopic Evacuation
Endoscopic surgery for treatment of supratentorial hypertensive intracerebral hemorrhage.
Other Name: neuroendoscopic surgery
Experimental: Experimental 2: Stereotactic Aspiration
Place a catheter into the main body of the hematoma and aspirate blood.
Procedure: Stereotactic Aspiration
Using image guidance to aspirate hematoma.
Other Name: Hematoma Stereotactic Aspiration
Active Comparator: Active Comparator: Craniotomy
Craniotomy with a big bone flap to for hematoma evacuation.
Craniotomy with a big bone flap to evacuate intracerebral hematoma.
Other Name: Craniotomy evacuation of hematoma
- 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.
- Hematoma Clearance Rate [ Time Frame: 24 hours and 3 days ]A ratio assessing extent of hematoma evacuation, ranging from 0 to 100%.
- Operation Time [ Time Frame: 24 hours ]The time from skin incision to the end of surgery.
- Intraoperative Blood Loss [ Time Frame: 24 hours ]Volume of blood lost during operation.
- Postoperative Glasgow Coma Scale [ Time Frame: 7 days ]A neurological scale to record the conscious state of patients at 1 week after surgery.
- Rebleeding Rate [ Time Frame: 3 days ]The percentage of patients that suffer from rebleeding after surgery. Rebleeding usually occurs within 3 days after surgery.
- Days of ICU Stay [ Time Frame: 14 days ]The time an ICH patient has to stay in intensive care unit after surgery.
- Mortality [ Time Frame: 30 days ]The percentage of patients that die within a month after the onset of hypertensive intracerebral hemorrhage.
- Intracranial Infection Rate [ Time Frame: 7 days ]Percentage of patients that get intracranial infection. The infection should be confirmed by cerebrospinal fluid tests.
- Barthel Index [ Time Frame: 6 months ]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.
- WHO Quality of Life-BREF [ Time Frame: 6 months ]The WHO Quality of Life-BREF comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment. It is an international cross-culturally comparable quality of life assessment instrument.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02811614
|Contact: Xinghua Xu, MDemail@example.com|
|Contact: Shujing Yao, MDfirstname.lastname@example.org|
|Chinese PLA General Hospital||Recruiting|
|Beijing, Beijing, China, 100853|
|Contact: Xiaolei Chen, MD +86-13466703648 email@example.com|
|Principal Investigator: Xiaolei Chen, MD|
|Principal Investigator:||Xiaolei Chen, MD||Chinese PLA General Hospital|