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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorYong Jiang

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Simple neuroendoscopic hematoma evacuation
  • Neuroendoscopic hematoma evacuation combined with sodium methylprednisolone succinate

Treatment groups

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Yong Jiang

Lead sponsor

The Affiliated Hospital Of Southwest Medical University

Sponsor institution