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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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.

Detailed Summary:

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.


Sponsor: Chinese PLA General Hospital

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: Chinese PLA General Hospital

Dates:
Date Received: June 20, 2016
Date Started: August 2016
Date Completion: April 2018
Last Updated: August 11, 2016
Last Verified: August 2016