Clinical trial Recruiting at 1 site Observational Ages 18 to 80

Minimally invasive surgery to remove deep (basal ganglia) brain hemorrhages

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

Run by 115 People's Hospital · NCT07234955 · Data updated 2026-11-12

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.

More Intracerebral Haemorrhage trials

Quick facts

Study typeObservational
Ages18 Years to 80 Years
SexAll
Enrollment300 (estimated)
Sponsor115 People's Hospital
Government
Locations1 site (Ho Chi Minh City, Ho Chi Minh)
StatusRecruiting
StartedSeptember 8, 2025
Main results expectedJanuary 1, 2028
Study endsSeptember 1, 2028
Registry record updatedNovember 19, 2025
Trial IDNCT07234955 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • People's Hospital 115
    Ho Chi Minh City, Ho Chi Minh, Vietnam
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.