Efficacy and Safety of NeuroEndoscopic Surgery for Large IntraCerebral Hemorrhage

NCT06894433 | Recruiting DMC

• 1 other identifier: Neurosurg 05
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Intracerebral Haemorrhage

Keywords

intracerebral hemorrhage; neuroendoscopic; craniotomy

Outcome Measures

Primary Outcomes (1)

• The proportion of patients with Modified Rankin Scale (mRS) score 0-3

  Functional outcome (comparing the intervention group to the control), assessed with the modified Rankin Scale (mRS) at 6 months.The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from: 0=No symptoms at all, 1=No significant disability, 2=Slight disability, 3=Moderate disability, 4=Moderately severe disability, 5=Severe disability and 6=death.

  180 days

Secondary Outcomes (11)

• Modified Rankin Scale (mRS) Score

  180 days

• mortality

  30 days, 90 days and 180 days

• Glasgow Outcome Scale Extended (GOS-E)

  180 days

• Assessment of cognitive function with Mini-Mental State Examination (MMSE)

  90 days and 180 days

• Quality of life measured with the 5-level EQ-5D (EQ-5D-5L)

  30 days and 180 days

Study Arms (2)

Experimental Arm

EXPERIMENTAL

Neuroendoscopic Surgery to remove intracranial hematoma

Procedure: neuroendoscopic surgery

Control Arm

ACTIVE COMPARATOR

Craniotomy to remove intracranial hematoma

Procedure: craniotomy

Interventions

neuroendoscopic surgery PROCEDURE

Subjects will receive Neuroendoscopic Surgery followed by standard medical management

Experimental Arm

craniotomy PROCEDURE

Subjects will receive Craniotomy followed by standard medical management

Control Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years old, male or female;
• 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);
• 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);
• Before randomization, GCS score was 5-14, NIHSS score was ≥6;
• mRS Before onset: 0-1 score;
• Randomization within 24 hours after the first diagnostic CT;
• The patient or family members are informed and voluntarily sign the informed consent;

You may not qualify if:

• The clinical diagnosis is caused by cerebral aneurysm, cerebrovascular malformation, moyamoya disease, brain trauma, brain tumor, massive cerebral infarction hemorrhage transformation, coagulation dysfunction, etc.;
• Thalamic hemorrhage, primary ventricular hemorrhage;
• Platelet count \<100×109/L, INR \> 1.4;
• Patients with advanced cerebral hernia (such as dilated bifidus and no light reflex) or unstable vital signs cannot tolerate surgery;
• Irreversible brain stem impairment (eye fixation, bilateral pupil dilation), GCS≤4 points;
• Any history of parenchyma or other intracranial subarachnoid, subdural or epidural blood and surgical history in the past 30 days;
• Patients with severe advanced cognitive impairment (such as AD) or who are not expected to complete the follow-up plan as required;
• Complicated with other serious diseases: including respiratory, circulation, digestion, urinary, endocrine, immune and blood systems;
• Pregnant or breastfeeding women, or those who expect to become pregnant within one year;
• are participating in other clinical trials (excluding: observational studies that do not involve intervention, natural history and/or epidemiological studies).

Sponsors & Collaborators

• Southwest Hospital, China: lead

Study Sites (2)

Southwest Hospital

Chongqing, Chongqing Municipality, 400038, China

RECRUITING

Dazhu County People's Hospital

Dazhou, Sichuan, 635100, China

RECRUITING

Related Publications (14)

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  PMID: 38598795 BACKGROUND

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MeSH Terms

Conditions

Cerebral Hemorrhage

Interventions

Craniotomy

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neurosurgical Procedures; Surgical Procedures, Operative

Study Officials

• Rong Hu, MD

  PLA Army Medical University

  STUDY CHAIR

Central Study Contacts

Rong Hu, MD

CONTACT

8615123917123; huchrong@aliyun.com

Hua Feng, MD

CONTACT

8613708321681; fenghua201818@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Neurosurgery

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: March 25, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)