Minimally invasive surgery to remove deep (basal ganglia) brain hemorrhages
Evaluation Of The Efficacy And Safety Of Minimally Invasive Surgery In Patients With Spontaneous Deep Intracerebral Hemorrhage
This observational study will see if minimally invasive surgery helps adults aged 18–80 with spontaneous deep (basal ganglia) intracerebral hemorrhage who present within 72 hours, compared with standard medical care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | 115 People's Hospital Government |
| Locations | 1 site (Ho Chi Minh City, Ho Chi Minh) |
| Trial ID | NCT07234955 on ClinicalTrials.gov |
What this trial studies
This is a prospective, multicenter observational cohort enrolling consecutive adults with spontaneous basal ganglia intracerebral hemorrhage at two hospitals in Ho Chi Minh City. Patients with hematoma volume 30–80 mL and GCS 5–14 who present within 72 hours are followed, while treatment decisions (minimally invasive surgery versus medical management) are made by the treating teams in routine practice. Clinical, laboratory, and imaging data are recorded prospectively using standardized case report forms, and details of any MIS procedures are documented. Outcomes including survival and functional status are measured through 180 days.
Who should consider this trial
Good fit: Adults 18–80 years with spontaneous basal ganglia intracerebral hemorrhage confirmed by CT, hematoma volume 30–80 mL, GCS 5–14, pre-stroke mRS 0–1, and presentation within 72 hours are the intended candidates.
Not a fit: Patients with secondary causes of hemorrhage, primary thalamic or infratentorial bleeds, very large intraventricular extension, uncorrectable coagulopathy, end-stage organ failure, or an urgent need for long-term anticoagulation are unlikely to benefit from the MIS approach evaluated here.
Why it matters
Potential benefit: If successful, this approach could lower death and long-term disability by removing deep hematomas with less brain injury than open surgery.
How similar studies have performed: Minimally invasive clot removal has shown promising but mixed results in prior trials (stronger data in lobar ICH and mixed signals in trials such as MISTIE), while data specifically for basal ganglia hemorrhage and procedures performed 24–72 hours after onset remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 this trial is running
Ho Chi Minh City, Ho Chi Minh
- People's Hospital 115 — Ho Chi Minh City, Ho Chi Minh, Vietnam (Recruiting)
Study contacts
- Study coordinator: Huy Q Huynh, MD
- Email: dr.huynhquochuy@gmail.com
- Phone: +84 943054927
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.