Minimally Invasive Surgery for Spontaneous Deep Intracerebral Hemorrhage
Starting soon
Conditions studied: Intracerebral Hemorrhage, Spontaneous Intracerebral Hemorrhage, Basal Ganglia Hemorrhage
In brief
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.
Key facts
- Study ID
- NCT07710313
- Run by
- Tam Anh Research Institute
- People needed
- 300
- Starts
- 2026-07-01
- Expected to finish
- 2028-12-31
- Last updated by the study team
- 2026-07-17
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
- 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)
- Glasgow Coma Scale (GCS) score between 5 and 14
- Pre-stroke modified Rankin Scale (mRS) score of 0 to 1
You may not qualify if…
- 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
- NIHSS score < 5
- Bilaterally fixed and dilated pupils with no light reflexes
- Decerebrate posturing
- Platelet count < 75,000/μL
- IINR > 1.4 after correction
- Ongoing anticoagulation that cannot be rapidly reversed
- Indication for long-term anticoagulation within 5 days of symptom onset
- End-stage renal disease
- End-stage liver disease
- Presence of a mechanical heart valve
- Comorbid condition associated with a life expectancy < 6 months
- Inability or unwillingness of the participant or legally authorized representative to provide written informed consent
Full record on ClinicalTrials.gov
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