RecruitingNCT07234955

Minimally Invasive Surgery For Patients With Spontaneous Deep Intracerebral Hemorrhage

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


Sponsor

Huynh Quoc Huy

Enrollment

300 participants

Start Date

Sep 8, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria6

  • 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 Criteria16

  • 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

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Locations(1)

People's Hospital 115

Ho Chi Minh City, Ho Chi Minh, Vietnam

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NCT07234955


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