NCT05539859

Efficacy and Safety of NeuroEndoscopic Surgery for IntraCerebral Hemorrhage

Efficacy and Safety of NeuroEndoscopic Surgery for IntraCerebral Hemorrhage: a Randomised, Controlled, Open-label, Blinded Endpoint Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 560 (estimated)
• Sponsor: Southwest Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To compare the efficacy and safety of neuroendoscopic hematoma removal and standard conservative treatment for patients with spontaneous supratentorial deep intracerebral hemorrhage.

Detailed description

Neuroendoscopic treatment of spontaneous intracerebral hemorrhage (ICH) is more and more widely used, but multi-center clinical study on the efficacy and safety of neuroendoscopic treatment of ICH is relatively small. Based on the lack of sufficient clinical evidence, the investigators plan to conduct a prospective, multicenter, randomized controlled clinical trial to investigate the safety and efficacy of neuroendoscopy in the treatment of spontaneous cerebral parenchymal hemorrhage, so as to provide evidence-based medical evidence for endoscopic minimally invasive treatment of cerebral hemorrhage and its application.The aim of trial was to determine whether the endoscopic surgery could achieve the benefits of clot evacuation and improve functional outcome at 180 days after ICH without procedure-related safety events or additional brain injury beyond the risks associated with standard care

Conditions

• Intracerebral Hemorrhage Basal Ganglia

Interventions

Type	Name	Description
PROCEDURE	Endoscopic surgery	Subjects will receive surgical hematoma evacuation using neuroendoscope, followed by medical management
OTHER	Medical management	Subjects will initially receive the standard medical therapies for the treatment of intracerebral hemorrhage, according to the latest available guideline.

Timeline

• Start date: 2022-11-18
• Primary completion: 2025-09-01
• Completion: 2026-09-01
• First posted: 2022-09-14
• Last updated: 2024-05-10

Locations

4 sites across 1 country: China