Neuroendoscopic Hematoma Evacuation Combined With Methylprednisolone Sodium Succinate in the Trea… (NCT06924983) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Neuroendoscopic Hematoma Evacuation Combined With Methylprednisolone Sodium Succinate in the Treatment of Basal Ganglia Intracerebral Hemorrhage at the Early Stage
China100 participantsStarted 2025-05-01
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.