Neuroendoscopic Hematoma Evacuation Combined With Methylprednisolone Sodium Succinate in the Trea… (NCT06921616) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Neuroendoscopic Hematoma Evacuation Combined With Methylprednisolone Sodium Succinate in the Treatment of Lobar Intracerebral Hemorrhage at the Early Stage.
China396 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 lobar intracerebral hemorrhage within 24 hours after the onset.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. The age ranges from 18 to 80 years old.
. Diagnosed as spontaneous intracerebral hemorrhage (ICH) by cranial computed tomography (CT) examination, with the bleeding site located in the lobar region of the brain.
. 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.
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. The National Institutes of Health Stroke Scale (NIHSS) score ≥ 6 points at the time of randomization.
. The Glasgow Coma Scale (GCS) score is between 5 and 14 points at the time of randomization.
. The modified Rankin Scale (mRS) score is 0-1 points prior to the onset of the disease.
. The patient and his or her legal representative sign the written informed consent form.
Exclusion criteria
. Hemorrhage in other locations (e.g., hemorrhage in infratentorial sites such as the basal ganglia, thalamus, brainstem, or cerebellum).
. 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.
. 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.
. 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.
. 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.