Neuroendoscopic Hematoma Evacuation Combined With Methylprednisolone Sodium Succinate in the Treatment of Basal Ganglia Intracerebral Hemorrhage at the Early Stage
NCT ID: NCT06924983
Last Updated: 2025-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
100 participants
INTERVENTIONAL
2025-05-01
2027-01-31
Brief Summary
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Detailed Description
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This study aims to systematically evaluate the efficacy and safety of neuroendoscopic hematoma evacuation combined with the early use of methylprednisolone sodium succinate in patients with basal ganglia intracerebral hemorrhage through a multicenter, prospective, randomized controlled clinical trial. The study will compare the differences in main endpoint indicators such as functional independence, quality of life and survival rate at 3 months and 6 months after surgery between the group receiving surgical treatment combined with methylprednisolone sodium succinate and the group receiving surgical treatment alone, so as to explore the impact of different treatment strategies on the prognosis of patients with basal ganglia intracerebral hemorrhage.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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The neuroendoscopic treatment group
For patients with spontaneous basal ganglia hemorrhage within 24 hours after the onset, simple neuroendoscopic hematoma evacuation was performed.
Simple neuroendoscopic hematoma evacuation
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 methylprednisolone sodium succinate combined with neuroendoscopic treatment group
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.
Neuroendoscopic hematoma evacuation combined with sodium methylprednisolone succinate
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.
Interventions
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Simple neuroendoscopic hematoma evacuation
For patients with spontaneous intracerebral hemorrhage within 24 hours after the onset of the disease, only simple neuroendoscopic evacuation of hematoma will be performed
Neuroendoscopic hematoma evacuation combined with sodium methylprednisolone succinate
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.
Eligibility Criteria
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Inclusion Criteria
2. Diagnosed with spontaneous intracerebral hemorrhage (ICH) through cranial CT scan, with the bleeding site located in the basal ganglia region.
3. 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.
4. 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.
5. The National Institutes of Health Stroke Scale (NIHSS) score should be ≥ 6 points at the time of randomization.
6. The Glasgow Coma Scale (GCS) score should range from 5 to 14 points at the time of randomization.
7. The modified Rankin Scale (mRS) score before the onset of the disease should be 0 - 1 points.
8. The patient and their legal representative should sign a written informed consent form.
Exclusion Criteria
2. 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.
3. Patients with intraventricular hemorrhage or those with intracerebral hemorrhage (ICH) breaking into the ventricles and considered to require external ventricular drainage.
4. 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.
5. Patients with genetic or acquired bleeding tendencies, coagulation disorders such as deficiency of coagulation factors.
6. Platelet count \< 75 × 10⁹/L.
7. Undergoing anticoagulant drug treatment with warfarin, dabigatran, or rivaroxaban, etc. within one week before enrollment, and having an international normalized ratio (INR) \> 1.4.
8. Expected to require long-term anticoagulation and antiplatelet therapy.
9. 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.
10. Myocardial infarction occurred within the recent 30 days.
11. 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.
12. 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.
13. Patients with Alzheimer's disease or mental disorders who are unable to complete the follow-up plan as required.
14. 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.
15. Allergic to drugs or devices related to the operation.
16. Pregnant or lactating women, or those planning to become pregnant within one year.
17. In the terminal stage of any disease with an expected lifespan of less than 6 months.
18. Currently participating in other clinical trials or having been previously enrolled in this trial.
19. The patient or his/her legal guardian is unwilling to sign the written informed consent form.
18 Years
80 Years
ALL
No
Sponsors
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Yong Jiang
OTHER
Responsible Party
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Yong Jiang
Prof.
Locations
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The Affiliated Hospital of Southwest Medical University
Luzhou, China, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2025135
Identifier Type: -
Identifier Source: org_study_id
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