Could a gentle surgical approach improve outcomes after deep brain bleeding?
NCT ID NCT07710313
First seen Jul 17, 2026 · Last updated Jul 17, 2026
Summary
This study looks at whether a minimally invasive surgical procedure can help people with a spontaneous deep brain hemorrhage (bleeding in the basal ganglia) recover better than standard medical treatment alone. Researchers will follow 300 adults for 180 days, measuring survival, functional independence, and safety. The goal is to see if this less invasive surgery reduces complications and improves quality of life after a serious stroke.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- minimally invasive surgery (a procedure to remove blood from the brain through small openings)
- What this could lead to
- If this approach proves effective, it could offer a safer, more precise treatment option for deep brain hemorrhages, potentially improving survival and recovery.
- What could go wrong
- This is an observational study, not a randomized trial, so results may be influenced by patient selection. The surgery itself carries risks like rebleeding or infection.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The study population consists of adult patients with spontaneous basal ganglia intracerebral hemorrhage treated at participating stroke centers in Vietnam. Eligible patients are aged 18 to 80 years and have a diagnosis of spontaneous basal ganglia hemorrhage confirmed by non-contrast computed tomography (CT). Patients must have a hematoma volume between 30 and 80 mL, calculated using the ABC/2 method, and be enrolled within 72 hours of symptom onset (or last known well time if symptom onset is unknown). Additional eligibility criteria include a Glasgow Coma Scale (GCS) score between 5 and 14 and a pre-stroke modified Rankin Scale (mRS) score of 0 to 1. The study aims to evaluate the effectiveness and safety of minimally invasive surgery compared with standard medical treatment in a real-world clinical setting and to provide evidence regarding patient selection and optimal timing of intervention for deep intracerebral hemorrhage.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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