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

Launched by YONG JIANG · Apr 9, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to treat a type of stroke called lobar intracerebral hemorrhage, which is bleeding in a specific area of the brain. The researchers want to find out if a combination of a surgical procedure to remove the blood clot (called neuroendoscopic hematoma evacuation) and a medication called methylprednisolone can help patients recover better than just the surgery alone. This trial will include adults aged 18 to 80 who have been diagnosed with this type of bleeding within 24 hours of their symptoms starting and have certain levels of bleeding in their brain.

To participate in the trial, patients should not have other medical conditions that complicate their situation, such as bleeding from different areas of the brain or severe health issues that could affect the results of the study. If eligible, participants can expect to receive the treatment and follow-up care, while contributing to research that may improve future stroke treatments. It's important for potential participants to understand that they will need to provide consent to take part in the trial, ensuring they are informed about what it involves.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. The age ranges from 18 to 80 years old.
• • 2. Diagnosed as spontaneous intracerebral hemorrhage (ICH) by cranial computed tomography (CT) examination, with the bleeding site located in the lobar region of the brain.
• • 3. Calculate the hematoma volume according to the cranial CT examination, which should be within the range of 30 to 80 ml, and the shift of the midline structure at the level of the pineal gland is less than 3 mm. The formula for calculating the hematoma volume V (cubic centimeters) is V = A × B × C × 1/2. Here, A represents the longest diameter (in centimeters) of the largest hematoma layer on the horizontal position of the plain CT scan, B refers to the widest diameter (in centimeters) of the hematoma perpendicular to A on this plane, and C stands for the thickness (in centimeters) of the hematoma shown on the CT film.
• • 4. The time interval from the onset of the disease to randomization is within 24 hours. In case the actual onset time is not clear, 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 ≥ 6 points at the time of randomization.
• • 6. The Glasgow Coma Scale (GCS) score is between 5 and 14 points at the time of randomization.
• • 7. The modified Rankin Scale (mRS) score is 0-1 points prior to the onset of the disease.
• • 8. The patient and his or her legal representative sign the written informed consent form.
• Exclusion Criteria:
• • 1. Hemorrhage in other locations (e.g., hemorrhage in infratentorial sites such as the basal ganglia, thalamus, brainstem, or cerebellum).
• • 2. Hemorrhage due to other causes (e.g., hemorrhage resulting from aneurysm, arteriovenous malformation, brain trauma, brain tumor, hemorrhagic transformation of large-area cerebral infarction, hemorrhage caused by amyloid angiopathy, hemorrhage due to coagulation disorders) or complicated by aneurysm, arteriovenous malformation, brain trauma, brain tumor, large-area cerebral infarction, amyloid angiopathy, severe coagulation disorders.
• • 3. Patients with intraventricular hemorrhage or those in whom intracerebral hemorrhage (ICH) has ruptured into the ventricles and who are 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 past 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 occurring within the past 30 days.
• • 11. Known to have a high embolism risk, including patients with mechanical heart valves implanted in vivo, 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.