NCT07234955

Minimally Invasive Surgery For Patients With Spontaneous Deep Intracerebral Hemorrhage

Evaluation Of The Efficacy And Safety Of Minimally Invasive Surgery In Patients With Spontaneous Deep Intracerebral Hemorrhage

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Huynh Quoc Huy · Other Government
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This observational cohort study evaluates the safety and effectiveness of minimally invasive surgery (MIS) compared with standard medical management in adults with spontaneous deep intracerebral hemorrhage. Consecutive patients admitted to People's Hospital 115 and Tam Anh General Hospital will be enrolled within 72 hours of onset. Clinical and imaging data will be collected prospectively, and outcomes including survival and functional status will be assessed through 180 days.

Detailed description

Spontaneous deep intracerebral hemorrhage (ICH) is associated with high early mortality and long-term disability. Conventional craniotomy has not consistently improved functional outcomes, while medical management alone often results in poor prognosis. Minimally invasive surgery (MIS), including parafascicular approaches guided by neuronavigation, is designed to evacuate hematomas with reduced disruption of critical white-matter tracts. Evidence supporting MIS is more robust in lobar ICH, whereas data for basal ganglia hemorrhage remain limited. Furthermore, most prior studies restricted surgical intervention to within 24 hours from onset, leaving uncertainty regarding potential benefit when performed between 24 and 72 hours. This prospective, multicenter, observational cohort study is conducted at People's Hospital 115 and Tam Anh General Hospital. Consecutive patients admitted with spontaneous basal ganglia ICH are enrolled within 72 hours of onset. Decisions regarding MIS, including whether to operate and the timing of surgery, are made by treating clinical teams in routine practice. The study does not assign interventions but documents real-world management and outcomes. Data are captured prospectively using standardized CRFs and electronic CRFs. Information includes demographics, comorbidities, presenting neurological status, laboratory and imaging findings, details of MIS when performed, intensive care and hospital course, and follow-up assessments through 180 days. The primary endpoint is functional outcome at 180 days, while safety endpoints include mortality and treatment-related complications. Analyses are planned using prespecified multivariable approaches to account for confounding by indication. Additional subgroup analyses will assess outcomes by timing of MIS (0-24 vs 24-72 hours) and other clinically relevant variables. By focusing on basal ganglia hemorrhage in contemporary Vietnamese stroke centers, this study is intended to generate real-world evidence on the effectiveness and safety of MIS in deep ICH and inform selection criteria and timing for future interventional trials.

Conditions

• Intracerebral Hemorrhage Basal Ganglia
• Intracerebral Haemorrhage

Timeline

• Start date: 2025-09-08
• Primary completion: 2028-01-01
• Completion: 2028-09-01
• First posted: 2025-11-19
• Last updated: 2025-11-19

Locations

1 site across 1 country: Vietnam