Efficacy and Safety of NeuroEndoscopic Surgery for Large IntraCerebral Hemorrhage

NCT ID: NCT06894433

Last Updated: 2025-05-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2028-12-31

Brief Summary

This is a multicenter, randomized, controlled clinical trial comparing neuroendoscopic hematoma removal to craniotomy in the treatment of large intracerebral hemorrhage.

Detailed Description

Previous retrospective studies have demonstrated that neuroendoscopic surgery, compared to conventional craniotomy, significantly reduces operative duration and intraoperative blood loss, enhances hematoma evacuation rates, and improves postoperative outcomes, including neurological recovery, activities of daily living, and quality of life in patients with large cerebral hemorrhage. However, there is a paucity of prospective randomized controlled trials evaluating the efficacy of different surgical techniques for intracerebral hemorrhage. To address this gap, the investigators propose a multicenter, randomized, controlled clinical trial to compare the safety and efficacy of neuroendoscopic surgery versus craniotomy, aiming to provide evidence-based guidance for surgical decision-making in cerebral hemorrhage management.

Conditions

Intracerebral Haemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental Arm

Neuroendoscopic Surgery to remove intracranial hematoma

Group Type: EXPERIMENTAL

neuroendoscopic surgery

Intervention Type: PROCEDURE

Subjects will receive Neuroendoscopic Surgery followed by standard medical management

Control Arm

Craniotomy to remove intracranial hematoma

Group Type: ACTIVE_COMPARATOR

craniotomy

Intervention Type: PROCEDURE

Subjects will receive Craniotomy followed by standard medical management

Interventions

neuroendoscopic surgery

Subjects will receive Neuroendoscopic Surgery followed by standard medical management

Intervention Type: PROCEDURE

craniotomy

Subjects will receive Craniotomy followed by standard medical management

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Age 18-80 years old, male or female;

2. The time between onset and admission to the first diagnostic CT is within 24 hours (for no bystanders and the time of onset is unknown, the time of the last known patient in good condition is used);

3. Patients with supratentorial intracerebral hemorrhage (supratentorial intracerebral hemorrhage (supratentorial intracerebral hemorrhage) whose hematoma volume is ≥50ml or whose hematoma produces obvious space occupying effect and requires emergency surgery (including patients with cerebral hernia signs such as retarding or dilatation of light reflex of one pupil);

4. Before randomization, GCS score was 5-14, NIHSS score was ≥6;

5. mRS Before onset: 0-1 score;

6. Randomization within 24 hours after the first diagnostic CT;

7. The patient or family members are informed and voluntarily sign the informed consent;

Exclusion Criteria

1. The clinical diagnosis is caused by cerebral aneurysm, cerebrovascular malformation, moyamoya disease, brain trauma, brain tumor, massive cerebral infarction hemorrhage transformation, coagulation dysfunction, etc.;

2. Thalamic hemorrhage, primary ventricular hemorrhage;

3. Platelet count <100×109/L, INR > 1.4;

4. Patients with advanced cerebral hernia (such as dilated bifidus and no light reflex) or unstable vital signs cannot tolerate surgery;

5. Irreversible brain stem impairment (eye fixation, bilateral pupil dilation), GCS≤4 points;

6. Any history of parenchyma or other intracranial subarachnoid, subdural or epidural blood and surgical history in the past 30 days;

7. Patients with severe advanced cognitive impairment (such as AD) or who are not expected to complete the follow-up plan as required;

8. Complicated with other serious diseases: including respiratory, circulation, digestion, urinary, endocrine, immune and blood systems;

9. Pregnant or breastfeeding women, or those who expect to become pregnant within one year;

10. are participating in other clinical trials (excluding: observational studies that do not involve intervention, natural history and/or epidemiological studies).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Southwest Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Rong Hu, MD

Director of Department of Neurosurgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rong Hu, MD

Role: STUDY_CHAIR

PLA Army Medical University

Locations

Southwest Hospital

Chongqing, Chongqing Municipality, China

Site Status: RECRUITING

Dazhu County People's Hospital

Dazhou, Sichuan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Rong Hu, MD

Role: CONTACT

huchrong@aliyun.com

8615123917123

Hua Feng, MD

Role: CONTACT

fenghua201818@aliyun.com

8613708321681

Facility Contacts

Rong Hu, MD

Role: primary

huchrong@aliyun.com

8615123917123

Sheng Zhu, MD

Role: primary

371773434@qq.com

+8615882911301

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Other Identifiers

Neurosurg 05

Identifier Type: -

Identifier Source: org_study_id