Minimally Invasive Surgery for Spontaneous Deep Intracerebral Hemorrhage (NCT07710313) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Minimally Invasive Surgery for Spontaneous Deep Intracerebral Hemorrhage
300 participantsStarted 2026-07-01
Plain-language summary
This observational cohort study evaluates the real-world effectiveness and safety of minimally invasive surgery (MIS) versus standard medical management in adults with spontaneous deep intracerebral hemorrhage. Patients presenting to Tam Anh General Hospital and People's Hospital 115 within 72 hours of hemorrhage onset will be enrolled and followed for 180 days. Clinical, radiological, and treatment-related variables will be collected, with primary outcome measures including survival and functional outcomes during follow-up period.
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
* Hematoma volume between 30 and 80 mL (calculated using the ABC/2 method)
* Time from symptom onset to enrollment ≤ 72 hours (for patients with an unknown onset time, the last known well time will be used)
* Glasgow Coma Scale (GCS) score between 5 and 14
* Pre-stroke modified Rankin Scale (mRS) score of 0 to 1
Exclusion Criteria:
* Secondary intracerebral hemorrhage due to trauma, brain tumor, arteriovenous malformation, cerebral aneurysm, or hemorrhagic transformation of ischemic stroke
* Infratentorial hemorrhage involving the brainstem or cerebellum
* Primary thalamic hemorrhage
* Intraventricular extension occupying more than 50% of either lateral ventricle
* NIHSS score \< 5
* Bilaterally fixed and dilated pupils with no light reflexes
* Decerebrate posturing
* Platelet count \< 75,000/μL
* IINR \> 1.4 after correction
* Ongoing anticoagulation that cannot be rapidly reversed
* Indication for long-term anticoagulation within 5 days of symptom onset
* End-stage renal disease
* End-stage liver disease
* Presence of a mechanical heart valve
* Comorbid condition associated with a life expectancy \< 6 months
* Inability or unwillingness of the participant or legally authorized representative 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
1
Functional Outcome by modified Rankin Scale (mRS)
Timeframe: 180 days after symptom onset
2
Functional Outcome by Utility-Weighted modified Rankin Scale (UW-mRS)
Timeframe: 180 days after symptom onset
3
Safety: All-Cause Mortality at 30 days
Timeframe: 30 days after symptom onset
4
Safety: Change in Hematoma Volume (Δ volume)
Timeframe: Within 24 hours after MIS (MIS group) or within 6-36 hours after the baseline CT scan (standard medical treatment group)
5
Safety: Treatment-Related Complications
Timeframe: From treatment initiation through 30 days after symptom onset