Neuroendoscopic Hematoma Evacuation Combined With Methylprednisolone Sodium Succinate in the Treatment of Basal Ganglia Intracerebral Hemorrhage at the Early Stage

NCT06924983 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 2025135
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this trial is to investigate whether neuroendoscopic hematoma evacuation combined with early use of methylprednisolone sodium succinate can improve the efficacy and safety in the treatment with that of simple neuroendoscopic surgery alone for patients with spontaneous basal ganglia intracerebral hemorrhage within 24 hours after the onset.

Conditions

Stroke; Intracerebral Hemorrhage Basal Ganglia; Methylprednisolone; Surgery

Outcome Measures

Primary Outcomes (2)

• Modified Rankin scale score (mRS)

  disability level. The presence of impairments determines the transitions from mRS score 0 to mRS score 1 (symptoms) and mRS score 5 to mRS score 6 (death).

  180 days

• The mortality rate

  evaluate death rate of the two treatment groups

  30 days

Secondary Outcomes (12)

• Proportion of patients non-disabled (Modified Rankin scale score (mRS) 0 to 1)

  180 days

• Proportion of patients functionally independent (Modified Rankin scale score (mRS) 0 to 2)

  180 days

• Proportion of patients ambulatory or bodily needs-capable or better (Modified Rankin scale score (mRS) 0 to 3)

  180 days

• Change in National Institute of Health stroke scale (NIHSS) score between baseline and 7~10d or at discharge

  7~10 days or at discharge

• Change in Glasgow Coma Scale(GCS) between baseline and 7~10d or at discharge

  7~10 days or at discharge

Study Arms (2)

The neuroendoscopic treatment group

ACTIVE COMPARATOR

For patients with spontaneous basal ganglia hemorrhage within 24 hours after the onset, simple neuroendoscopic hematoma evacuation was performed.

Procedure: Simple neuroendoscopic hematoma evacuation

The methylprednisolone sodium succinate combined with neuroendoscopic treatment group

EXPERIMENTAL

For patients with spontaneous basal ganglia hemorrhage within 24 hours after the onset, neuroendoscopic hematoma evacuation combined with methylprednisolone sodium succinate treatment was carried out.

Combination Product: Neuroendoscopic hematoma evacuation combined with sodium methylprednisolone succinate

Interventions

Simple neuroendoscopic hematoma evacuation PROCEDURE

For patients with spontaneous intracerebral hemorrhage within 24 hours after the onset of the disease, only simple neuroendoscopic evacuation of hematoma will be performed

The neuroendoscopic treatment group

Neuroendoscopic hematoma evacuation combined with sodium methylprednisolone succinate COMBINATION_PRODUCT

For patients with spontaneous intracerebral hemorrhage within 24 hours after the onset of the disease, they will be treated with the combination of neuroendoscopic hematoma evacuation and sodium methylprednisolone succinate. Administer sodium methylprednisolone succinate for injection by intravenous injection 6 hours after the onset of the disease. Specific administration: Intravenous injection at a dosage of 2 mg/kg, once daily, for three consecutive days.

The methylprednisolone sodium succinate combined with neuroendoscopic treatment group

Eligibility Criteria

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

You may qualify if:

• Aged between 18 and 80 years old.
• Diagnosed with spontaneous intracerebral hemorrhage (ICH) through cranial CT scan, with the bleeding site located in the basal ganglia region.
• Calculate the hematoma volume based on the cranial CT scan. The volume should range from 30 to 80 ml, and the shift of the mid - line structure at the pineal gland level should be less than 3 mm. The formula for calculating the hematoma volume is V (cm³)=A \* B \* C \* 1/2, where A represents the longest diameter (cm) of the largest hematoma layer in the horizontal position of the plain CT scan, B is the widest diameter (cm) of the hematoma perpendicular to A on this plane, and C is the thickness (cm) of the hematoma shown in the CT images.
• The time from the onset of the disease to randomization should be within 24 hours. If the actual onset time is unclear, the onset time will be regarded as the time when the subject was last confirmed to be in good health.
• The National Institutes of Health Stroke Scale (NIHSS) score should be ≥ 6 points at the time of randomization.
• The Glasgow Coma Scale (GCS) score should range from 5 to 14 points at the time of randomization.
• The modified Rankin Scale (mRS) score before the onset of the disease should be 0 - 1 points.
• The patient and their legal representative should sign a written informed consent form.

You may not qualify if:

• Hemorrhage in other locations (such as hemorrhage in infratentorial regions like the lobes, thalamus, brainstem, or cerebellum).
• Hemorrhage caused by other reasons (for example, hemorrhage due to aneurysm, arteriovenous malformation, brain trauma, brain tumor, hemorrhagic transformation of large-area cerebral infarction, hemorrhage caused by amyloid angiopathy, hemorrhage resulting from coagulation disorders) or combined with aneurysm, arteriovenous malformation, brain trauma, brain tumor, large-area cerebral infarction, amyloid angiopathy, severe coagulation disorders.
• Patients with intraventricular hemorrhage or those with intracerebral hemorrhage (ICH) breaking into the ventricles and considered to require external ventricular drainage.
• A history of any parenchymal brain hemorrhage or other intracranial subarachnoid, subdural, or epidural hemorrhage and a history of relevant surgeries within the recent 30 days.
• Patients with genetic or acquired bleeding tendencies, coagulation disorders such as deficiency of coagulation factors.
• Platelet count \< 75 × 10⁹/L.
• Undergoing anticoagulant drug treatment with warfarin, dabigatran, or rivaroxaban, etc. within one week before enrollment, and having an international normalized ratio (INR) \> 1.4.
• Expected to require long-term anticoagulation and antiplatelet therapy.
• A history of previous internal hemorrhage, with risks of gastrointestinal bleeding (such as gastrointestinal ulcers), genitourinary bleeding, or respiratory tract bleeding that has not been fully controlled.
• Myocardial infarction occurred within the recent 30 days.
• Known to have a high embolism risk, including patients with mechanical heart valves implanted in the body, a history of left heart thrombus, mitral stenosis accompanied by atrial fibrillation, acute pericarditis, or subacute bacterial endocarditis. Atrial fibrillation without mitral stenosis is eligible.
• Severe liver function impairment, with alanine aminotransferase (ALT) \> 3 times the upper limit of the normal range, or aspartate aminotransferase (AST) \> 3 times the upper limit of the normal range. Severe renal insufficiency, with a glomerular filtration rate \< 30 ml/min/1.73 m².
• Patients with Alzheimer's disease or mental disorders who are unable to complete the follow-up plan as required.
• Complicated by any severe diseases that, upon evaluation, may interfere with the trial results, including diseases of the respiratory system, circulatory system, digestive system, genitourinary system, endocrine system, immune system, and hematopoietic system, etc.
• Allergic to drugs or devices related to the operation.

Sponsors & Collaborators

• Yong Jiang: lead

Study Sites (1)

The Affiliated Hospital of Southwest Medical University

Luzhou, China, 646000, China

Location

MeSH Terms

Conditions

Stroke

Interventions

Methylprednisolone Hemisuccinate

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Methylprednisolone; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Yong Jiang, MD

CONTACT

8613608280599; jiangyong@swmu.edu.cn

Jianhua Peng, MD

CONTACT

8615228285418; pengjianhua@swmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: April 13, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: April 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)