Minimally Invasive Surgery for Spontaneous Deep Intracerebral Hemorrhage
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorTam Anh Research Institute
About this trial
This observational cohort study evaluates the real-world effectiveness and safety of minimally invasive surgery (MIS) versus standard medical management in adults with spontaneous deep intracerebral hemorrhage. Patients presenting to Tam Anh General Hospital and People's Hospital 115 within 72 hours of hemorrhage onset will be enrolled and followed for 180 days. Clinical, radiological, and treatment-related variables will be collected, with primary outcome measures including survival and functional outcomes during follow-up period.
Eligibility criteria
Qualifiers
Age 18 to 80 years
Spontaneous basal ganglia intracerebral hemorrhage confirmed by non-contrast CT
Hematoma volume between 30 and 80 mL (calculated using the ABC/2 method)
Time from symptom onset to enrollment ≤ 72 hours (for patients with an unknown onset time, the last known well time will be used)
Disqualifiers
Secondary intracerebral hemorrhage due to trauma, brain tumor, arteriovenous malformation, cerebral aneurysm, or hemorrhagic transformation of ischemic stroke
Infratentorial hemorrhage involving the brainstem or cerebellum
Primary thalamic hemorrhage
Intraventricular extension occupying more than 50% of either lateral ventricle
Trial design
Treatments tested in this trial
- Minimally Invasive Surgery (MIS)
- Standard medical treatment (SMT)
Treatment groups
300 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Tam Anh Research Institute
Lead sponsor
Tam Anh TP. Ho Chi Minh General Hospital
Collaborator
People's Hospital 115
Collaborator
Source ClinicalTrials.gov