RecruitingNot Applicable

Minimally Invasive Surgery For Patients With Spontaneous Deep Intracerebral Hemorrhage

Vietnam300 participantsStarted 2025-09-08

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 180 days after intracerebral hemorrhage

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

Timeframe: 180 days after intracerebral hemorrhage

Primary Outcome Measure 3 - Safety: All-Cause Mortality

Timeframe: 30 days after intracerebral hemorrhage

Primary Outcome Measure 4 - Safety: Procedure-Related Complications

Timeframe: Within hospitalization and up to 30 days after intracerebral hemorrhage

Trial details

NCT IDNCT07234955

SponsorHuynh Quoc Huy

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2028-01-01

Contact for this trial

Huy Q Huynh, MD

+84 943054927 dr.huynhquochuy@gmail.com

View on ClinicalTrials.gov More Intracerebral Hemorrhage Basal Ganglia trials

Plain-language summary

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: 180 days after intracerebral hemorrhage

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

Timeframe: 180 days after intracerebral hemorrhage

Primary Outcome Measure 3 - Safety: All-Cause Mortality

Timeframe: 30 days after intracerebral hemorrhage

Primary Outcome Measure 4 - Safety: Procedure-Related Complications

Timeframe: Within hospitalization and up to 30 days after intracerebral hemorrhage