Minimally Invasive Surgery For Patients With Spontaneous Deep Intracerebral Hemorrhage

NCT07234955 | Recruiting

• 1 other identifier: CS/15/25/48
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intracerebral Hemorrhage Basal Ganglia; Intracerebral Haemorrhage

Keywords

Deep Intracerebral Hemorrhage

Outcome Measures

Primary Outcomes (4)

• Primary Outcome Measure 1 - Efficacy: Functional Outcome by Modified Rankin Scale (mRS)

  Proportion of participants achieving favorable functional outcome defined as mRS 0-3. Unit of Measure: Percentage of participants

  180 days after intracerebral hemorrhage

• Primary Outcome Measure 2 - Efficacy: Functional Outcome by Utility-Weighted mRS (UW-mRS)

  Mean UW-mRS score at 180 days after intracerebral hemorrhage. The UW-mRS is a continuous, utility-weighted measure of functional outcome ranging from 0 (death) to 1 (no symptoms). Unit of Measure: Score (0-1 scale)

  180 days after intracerebral hemorrhage

• Primary Outcome Measure 3 - Safety: All-Cause Mortality

  Number of participants who die from any cause within 30 days after intracerebral hemorrhage. Unit of Measure: Percentage of participants

  30 days after intracerebral hemorrhage

• Primary Outcome Measure 4 - Safety: Procedure-Related Complications

  Incidence of major complications related to minimally invasive surgery or medical management, including but not limited to rebleeding, infection, seizures, or other serious adverse events as judged by the investigators. Unit of Measure: Number of participants with complications

  Within hospitalization and up to 30 days after intracerebral hemorrhage

Secondary Outcomes (3)

• Secondary Outcome Measure 1: Functional Outcome by Timing of MIS (0-24 Hours vs 24-72 Hours)

  180 days after intracerebral hemorrhage

• Secondary Outcome Measure 2: All-Cause Mortality at 30 Days by Timing of MIS (0-24 Hours vs 24-72 Hours)

  30 days after intracerebral hemorrhage

• Secondary Outcome Measure 3: Procedure-Related Complications by Timing of MIS (0-24 Hours vs 24-72 Hours)

  Within hospitalization and up to 30 days after intracerebral hemorrhage

Study Arms (2)

Minimally Invasive Surgery

Patients with spontaneous deep intracerebral hemorrhage who undergo minimally invasive surgery according to clinical practice.

Standard Medical Treatment

Patients with spontaneous deep intracerebral hemorrhage who receive conventional standard medical care according to clinical practice.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults aged 18 to 80 years admitted with spontaneous deep intracerebral hemorrhage located in the basal ganglia. Eligible patients will have hematoma volumes between 30 and 80 mL on CT scan, present within 72 hours of onset, and meet inclusion and exclusion criteria. Participants will be enrolled at People's Hospital 115 and collaborating centers in Vietnam.

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

Sponsors & Collaborators

• Huynh Quoc Huy: lead

Study Sites (1)

People's Hospital 115

Ho Chi Minh City, Ho Chi Minh, 700000, Vietnam

RECRUITING

MeSH Terms

Conditions

Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Thang H Nguyen, MD, Ph

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

  STUDY CHAIR

Central Study Contacts

Huy Q Huynh, MD

CONTACT

+84 943054927; dr.huynhquochuy@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Department of Neurology, People's Hospital 115

Study Record Dates

• First Submitted: September 25, 2025
• First Posted: November 19, 2025
• Study Start: September 8, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: November 19, 2025

Record last verified: 2025-11

Locations

VN (1)