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Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID05539859

Comparing Neuroendoscopic Surgery to Standard Medical Treatment for Deep Brain Bleeding in Adults Aged 18 to 80

Led by Southwest Hospital, China · Updated on 2024-05-10

560

Participants Needed

4

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

This research aims to compare the effectiveness and safety of neuroendoscopic surgery versus standard medical treatment in patients with spontaneous deep supratentorial intracerebral hemorrhage. The study is a prospective, multicenter, randomized controlled clinical trial designed to provide strong evidence on whether minimally invasive endoscopic surgery can safely remove blood clots and improve patient outcomes without causing extra brain injury beyond standard care risks. Participants will be randomly assigned to one of two groups one receiving surgical hematoma removal using a neuroendoscope followed by medical management, and the other receiving standard medical treatment according to the latest guidelines. Surgery must occur within 54 hours after symptom onset, with randomization completed within 24 hours of the first diagnostic CT scan. During the trial, participants will undergo assessments including the Modified Rankin Scale at 180 days to measure functional outcomes and safety events. Additional evaluations include the Glasgow Outcome Scale Extended, cognitive function tests with the Mini-Mental State Examination, quality of life surveys, and monitoring of survival rates, length of ICU stay, hospitalization duration, and in-hospital costs. Follow-up assessments occur at 30, 90, and 180 days to track progress and safety over time.

CONDITIONS

Brief Title

Efficacy and Safety of NeuroEndoscopic Surgery for IntraCerebral Hemorrhage

Research Team

R

Rong Hu, MD

H

Hua Feng, MD

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