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

Not Applicable

Completed

• Conditions: Intracranial Hemorrhage, Hypertensive
• Interventions: Procedure: Craniotomy; Procedure: Endoscopic Evacuation; Procedure: Stereotactic Aspiration

• Registration Number: NCT02811614
• Lead Sponsor: 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 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.

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 Timeline

• Study First Submitted: 2016-06-20
• Study First Submitted QC: 2016-06-21
• Study First Posted: 2016-06-23
• Study Start: 2016-07-01
• Primary Completion: 2022-06-30
• Study Completion: 2022-07-31
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-20
• Last Update Posted: 2023-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 733

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Comparator: Craniotomy	Craniotomy	Craniotomy with a big bone flap to for hematoma evacuation.
Experimental 1: Endoscopic Evacuation	Endoscopic Evacuation	Endoscopic hematoma evacuation with the help of a self-developed working channel.
Experimental 2: Stereotactic Aspiration	Stereotactic Aspiration	Place a catheter into the main body of the hematoma and aspirate blood.

Primary Outcome Measures

Name	Time	Method
Modified Rankin Scale	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

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

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China