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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
Sponsor:
Collaborators:
Jingzhou Central Hospital
Wuhan No.1 Hospital
Yichang Central Hospital.
Second Hospital of Jilin University
The First Affiliated Hospital of Nanchang University
Second Affiliated Hospital of Nanchang University
Tang-Du Hospital
The First Affiliated Hospital, Sun Yet-sen University
Jiangmen Central Hospital
Jilin Province People's Hospital
Siping Central Hospital
Minzu Hospital of Guangxi Zhuang Autonomous Region
Taihe Hospital
Information provided by (Responsible Party):
Xiaolei Chen, Chinese PLA General Hospital

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 surgeries will improve the outcome in patients with hypertensive intracerebral hemorrhage compared with craniotomy. Patients will be randomly assigned to endoscopy group, stereotactic aspiration group and craniotomy group in a 1:1:1 ratio.

Condition or disease Intervention/treatment Phase
Intracranial Hemorrhage, Hypertensive Procedure: Endoscopic Evacuation Procedure: Stereotactic Aspiration Procedure: Craniotomy Not Applicable

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. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
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.
Procedure: Craniotomy
Craniotomy with a big bone flap to evacuate intracerebral hematoma.
Other Name: Craniotomy evacuation of hematoma




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Hematoma Clearance Rate [ Time Frame: 24 hours and 3 days ]
    A ratio assessing extent of hematoma evacuation, ranging from 0 to 100%.

  2. Operation Time [ Time Frame: 24 hours ]
    The time from skin incision to the end of surgery.

  3. Intraoperative Blood Loss [ Time Frame: 24 hours ]
    Volume of blood lost during operation.

  4. Postoperative Glasgow Coma Scale [ Time Frame: 7 days ]
    A neurological scale to record the conscious state of patients at 1 week after surgery.

  5. Rebleeding Rate [ Time Frame: 3 days ]
    The percentage of patients that suffer from rebleeding after surgery. Rebleeding usually occurs within 3 days after surgery.

  6. Days of ICU Stay [ Time Frame: 14 days ]
    The time an ICH patient has to stay in intensive care unit after surgery.

  7. Mortality [ Time Frame: 30 days ]
    The percentage of patients that die within a month after the onset of hypertensive intracerebral hemorrhage.

  8. Intracranial Infection Rate [ Time Frame: 7 days ]
    Percentage of patients that get intracranial infection. The infection should be confirmed by cerebrospinal fluid tests.

  9. 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.

  10. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Supratentorial hypertensive intracerebral hemorrhage on CT scan with the hematoma volume >20mL
  • Adult patients with GCS score ≥5
  • Admitted within 24h of ictus

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Contacts
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Contact: Xinghua Xu, MD +86-18811212273 dr_xxh@126.com
Contact: Shujing Yao, MD +86-18801214301 xubn301@163.com

Locations
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China, Beijing
Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
Contact: Xiaolei Chen, MD    +86-13466703648    cda301@126.com   
Principal Investigator: Xiaolei Chen, MD         
Sponsors and Collaborators
Chinese PLA General Hospital
Jingzhou Central Hospital
Wuhan No.1 Hospital
Yichang Central Hospital.
Second Hospital of Jilin University
The First Affiliated Hospital of Nanchang University
Second Affiliated Hospital of Nanchang University
Tang-Du Hospital
The First Affiliated Hospital, Sun Yet-sen University
Jiangmen Central Hospital
Jilin Province People's Hospital
Siping Central Hospital
Minzu Hospital of Guangxi Zhuang Autonomous Region
Taihe Hospital
Investigators
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Principal Investigator: Xiaolei Chen, MD Chinese PLA General Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Xiaolei Chen, Professor, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT02811614    
Other Study ID Numbers: Chinese PLA General Hospital
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Xiaolei Chen, Chinese PLA General Hospital:
intracerebral hemorrhage,hypertensive
minimally invasive surgery
neuroendoscopic surgery
stereotactic aspiration
Additional relevant MeSH terms:
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Cerebral Hemorrhage
Intracranial Hemorrhages
Intracranial Hemorrhage, Hypertensive
Hemorrhage
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases