Minimally-invasive Surgery Versus Craniotomy in Patients With Supratentorial Hypertensive Intracerebral Hemorrhage (MISICH)

February 20, 2023 updated by: Xiaolei Chen, Chinese PLA General Hospital

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

733

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Beijing
      • Beijing, Beijing, China, 100853
        • Chinese PLA General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Supratentorial hypertensive intracerebral hemorrhage on CT scan with the hematoma volume ≥25mL
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental 1: Endoscopic Evacuation
Endoscopic hematoma evacuation with the help of a self-developed working channel.
Endoscopic surgery for treatment of supratentorial hypertensive intracerebral hemorrhage.
Other Names:
  • neuroendoscopic surgery
Experimental: Experimental 2: Stereotactic Aspiration
Place a catheter into the main body of the hematoma and aspirate blood.
Using image guidance to aspirate hematoma.
Other Names:
  • 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 Names:
  • Craniotomy evacuation of hematoma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hematoma Clearance Rate
Time Frame: 24 hours and 3 days
A ratio assessing extent of hematoma evacuation, ranging from 0 to 100%.
24 hours and 3 days
Operation Time
Time Frame: 24 hours
The time from skin incision to the end of surgery.
24 hours
Intraoperative Blood Loss
Time Frame: 24 hours
Volume of blood lost during operation.
24 hours
Postoperative Glasgow Coma Scale
Time Frame: 7 days
A neurological scale to record the conscious state of patients at 1 week after surgery.
7 days
Rebleeding Rate
Time Frame: 3 days
The percentage of patients that suffer from rebleeding after surgery. Rebleeding usually occurs within 3 days after surgery.
3 days
Days of ICU Stay
Time Frame: 14 days
The time an ICH patient has to stay in intensive care unit after surgery.
14 days
Mortality
Time Frame: 30 days
The percentage of patients that die within a month after the onset of hypertensive intracerebral hemorrhage.
30 days
Intracranial Infection Rate
Time Frame: 7 days
Percentage of patients that get intracranial infection. The infection should be confirmed by cerebrospinal fluid tests.
7 days
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.
6 months
Hospitalization expenses
Time Frame: 6 months
Total expenses during neurosurgery hospitalization
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

July 31, 2022

Study Registration Dates

First Submitted

June 20, 2016

First Submitted That Met QC Criteria

June 21, 2016

First Posted (Estimate)

June 23, 2016

Study Record Updates

Last Update Posted (Estimate)

February 22, 2023

Last Update Submitted That Met QC Criteria

February 20, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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