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NCT Number: NCT02811614

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

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.

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Key information

Conditions

Intracranial Hemorrhage, Hypertensive Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Intracranial Hemorrhages Nervous System Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endoscopic Evacuation

Procedure

Endoscopic surgery for treatment of supratentorial hypertensive intracerebral hemorrhage.

Other names: neuroendoscopic surgery

Stereotactic Aspiration

Procedure

Using image guidance to aspirate hematoma.

Other names: Hematoma Stereotactic Aspiration

Craniotomy

Procedure

Craniotomy with a big bone flap to evacuate intracerebral hematoma.

Other names: Craniotomy evacuation of hematoma

Primary outcomes

  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 outcomes

  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. Hospitalization expenses

    Time frame: 6 months

    Total expenses during neurosurgery hospitalization

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Collaborators

  • First Affiliated Hospital, Sun Yat-Sen University
  • Jiangmen Central Hospital
  • Jilin Province People's Hospital
  • Jingzhou Central Hospital
  • Minzu Hospital of Guangxi Zhuang Autonomous Region
  • Second Affiliated Hospital of Nanchang University
  • Second Hospital of Jilin University
  • Siping Central People's Hospital
  • Taihe Hospital
  • Tang-Du Hospital
  • The First Affiliated Hospital of Nanchang University
  • Wuhan No.1 Hospital
  • Yichang Central People's Hospital

Registry information

Official study title

Minimally-invasive Surgery Versus Craniotomy in Patients With Supratentorial Hypertensive Intracerebral Hemorrhage: A Multi-center Randomized Controlled Trial

Acronym: MISICH

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Jun 23, 2016
Registry last updated
Feb 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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