Minimally Invasive Surgery for Spontaneous Deep Intracerebral Hemorrhage
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorTam Anh Research Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Minimally Invasive Surgery (MIS)
Procedure/SurgeryPatients with spontaneous deep intracerebral hemorrhage who undergo minimally invasive surgery as part of routine clinical care. Decisions regarding surgical treatment and timing are made by the treating physicians according to standard practice. Clinical outcomes and safety outcomes will be evaluated through 180 days of follow-up.
Standard medical treatment (SMT)
Other interventionParticipants receive standard medical management according to current clinical practice guidelines for spontaneous intracerebral hemorrhage. Treatment decisions are made by the treating physicians. Clinical and safety outcomes will be evaluated through 180 days of follow-up.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: MIS Group1 intervention
Group B: Standard Medical Treatment Group1 intervention
Trial outcomes
Primary outcomes
1
Functional Outcome by modified Rankin Scale (mRS)
Proportion of participants with a favorable functional outcome, defined as mRS score of 0 to 3. Unit of Measure: Percentage of participants.
Time frame
180 days after symptom onset2
Functional Outcome by Utility-Weighted modified Rankin Scale (UW-mRS)
Mean UW-mRS score at 180 days after symptom onset. The UW-mRS is a utility-based measure of functional outcome ranging from 0 (death) to 1 (no symptoms). Unit of Measure: Score (range: 0 to 1)
Time frame
180 days after symptom onset3
Safety: All-Cause Mortality at 30 days
All-cause mortality within 30 days after symptom onset. Unit of Measure: Percentage of participants
Time frame
30 days after symptom onset4
Safety: Change in Hematoma Volume (Δ volume)
Δ volume calculated as the difference between hematoma volume measured on the follow-up CT scan (performed within 24 hours after minimally invasive surgery (MIS) for MIS group, or within 6-36 hours after baseline CT scan for standard medical treatment group) and that on the baseline CT scan (the first CT scan performed on hospital admission). Hematoma volume will be measured using the ABC/2 method. Unit of Measure: Milliliters (mL)
Time frame
Within 24 hours after MIS (MIS group) or within 6-36 hours after the baseline CT scan (standard medical treatment group)Secondary outcomes
1
Functional Outcome According to Timing of Minimally Invasive Surgery (MIS)
Among participants treated with minimally invasive surgery (MIS), the proportion achieving a favorable functional outcome, defined as a modified Rankin Scale (mRS) score of 0-3 at 180 days, and the median modified Rankin Scale (mRS) score at 180 days will be compared between participants undergoing MIS within 24 hours of symptom onset and those undergoing MIS within \>24-72 hours after symptom onset. Unit of Measure: Percentage of participants; Score (range: 0 to 6)
Time frame
180 days after symptom onset2
Safety: All-Cause Mortality According to Timing of Minimally Invasive Surgery (MIS)
Among participants treated with MIS, all-cause mortality within 30 days after symptom onset will be compared between those undergoing MIS within 0-24 hours of symptom onset and those undergoing MIS within \>24-72 hours after symptom onset. Unit of Measure: Percentage of participants
Time frame
30 days after symptom onset3
Safety: Treatment-Related Complications According to Timing of Minimally Invasive Surgery (MIS)
Among participants treated with MIS, the occurrence of one or more treatment-related complications, including rebleeding, surgical site infection or meningitis, new-onset seizures, progressive cerebral edema, hydrocephalus requiring external ventricular drainage or shunt placement, hypotension or shock requiring specific treatment, and neurological readmission within 30 days, will be compared between those undergoing MIS within 24 hours of symptom onset and those undergoing MIS within \>24-72 hours after symptom onset. Unit of Measure: Number of participants with one or more treatment-related complications
Time frame
From treatment initiation through 30 days after symptom onsetLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Tam Anh Research Institute
Lead sponsor
Tam Anh TP. Ho Chi Minh General Hospital
Collaborator
People's Hospital 115
Collaborator
Source ClinicalTrials.gov
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