NCT06921616

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

A Multicenter, Randomized Controlled Clinical Trial on the Efficacy and Safety of Neuroendoscopic Hematoma Evacuation Combined With Methylprednisolone Sodium Succinate in the Treatment of Lobar Intracerebral Hemorrhage at the Early Stage.

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 396 (estimated)
• Sponsor: Yong Jiang · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

There is still a lack of the best evidence-based reference for the treatment of lobar intracerebral hemorrhage. The ENRICH trial published in 2024 demonstrated that minimally invasive hematoma evacuation might have a better clinical prognosis than standard medical treatment in patients with spontaneous intracerebral hemorrhage. However, the significant effect of the surgery might be mainly attributed to the intervention in patients with lobar hemorrhage. Besides, simply relying on surgical removal of hematoma may not be sufficient to significantly improve the long-term prognosis of patients. How to effectively control secondary brain injury, reduce cerebral edema and inflammatory response is the key to improving the prognosis of patients with lobar intracerebral hemorrhage. Methylprednisolone sodium succinate can reduce the disruption of the blood-brain barrier and inflammatory response in animal models of intracerebral hemorrhage, and alleviate brain injury. The results of the MARVEL trial released in 2024 showed that methylprednisolone sodium succinate has demonstrated the potential to reduce the incidence of secondary intracerebral hemorrhage (ICH) and mortality in patients with acute ischemic stroke. 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 lobar 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 lobar intracerebral hemorrhage.

Conditions

• Stroke
• Intracerebral Hemorrhage Lobar
• Methylprednisolone
• Surgery

Interventions

Type	Name	Description
PROCEDURE	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
COMBINATION_PRODUCT	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.

Timeline

• Start date: 2025-05-01
• Primary completion: 2026-11-30
• Completion: 2027-01-31
• First posted: 2025-04-10
• Last updated: 2025-04-13

Locations

1 site across 1 country: China