Minimally Invasive Surgery For Patients With Spontaneous Deep Intracerebral Hemorrhage

Recruiting now

Conditions studied: Intracerebral Hemorrhage Basal Ganglia, Intracerebral Haemorrhage

In brief

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.

Key facts

Study ID

NCT07234955

Run by

Huynh Quoc Huy

People needed

300

Starts

2025-09-08

Expected to finish

2028-09-01

Last updated by the study team

2025-11-19

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 to 80 years
• Spontaneous basal ganglia intracerebral hemorrhage confirmed by non-contrast CT scan
• Hematoma volume 30-80 mL (ABC/2 method)
• Time from onset/last known well ≤ 72 hours
• Glasgow Coma Scale (GCS) score 5-14 at admission
• Pre-stroke modified Rankin Scale (mRS) score 0-1

You may not qualify if…

• Secondary intracerebral hemorrhage due to trauma, tumor, vascular malformation, aneurysm, or hemorrhagic transformation of ischemic stroke
• Infratentorial hemorrhage (brainstem or cerebellum)
• Primary thalamic hemorrhage
• Extensive intraventricular hemorrhage (>50% of one lateral ventricle)
• NIHSS < 5 at admission
• Bilateral fixed dilated pupils without light reflex
• Decerebrate posture
• Platelet count < 75,000/µL
• INR > 1.4 after correction
• Ongoing anticoagulation that cannot be rapidly reversed
• Indication for long-term anticoagulation within 5 days of onset
• End-stage renal disease
• End-stage liver disease
• Presence of mechanical heart valve
• Any comorbidity with life expectancy < 6 months
• Patient or legal representative unwilling or unable to provide written informed consent

Where it is running

• People's Hospital 115 — Ho Chi Minh City, Ho Chi Minh, Vietnam (enrolling)

Full record on ClinicalTrials.gov

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