Minimally Invasive Surgery For Patients With Spontaneous Deep Intracerebral Hemorrhage
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorHuynh Quoc Huy
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
300 Participants
are grouped into 2 trial groupsGroup A: Minimally Invasive Surgery
Group B: Standard Medical Treatment
Trial outcomes
Primary outcomes
1
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
Time frame
180 days after intracerebral hemorrhage2
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)
Time frame
180 days after intracerebral hemorrhage3
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
Time frame
30 days after intracerebral hemorrhage4
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
Time frame
Within hospitalization and up to 30 days after intracerebral hemorrhageSecondary outcomes
1
Secondary Outcome Measure 1: Functional Outcome by Timing of MIS (0-24 Hours vs 24-72 Hours)
Proportion of participants achieving favorable functional outcome (mRS 0-3) at 180 days, compared between patients undergoing minimally invasive surgery (MIS) within 0-24 hours and those undergoing MIS within 24-72 hours after intracerebral hemorrhage. Unit of Measure: Percentage of participants
Time frame
180 days after intracerebral hemorrhage2
Secondary Outcome Measure 2: All-Cause Mortality at 30 Days by Timing of MIS (0-24 Hours vs 24-72 Hours)
All-cause mortality within 30 days, compared between participants undergoing MIS within 0-24 hours versus 24-72 hours after intracerebral hemorrhage. Unit of Measure: Percentage of participants.
Time frame
30 days after intracerebral hemorrhage3
Secondary Outcome Measure 3: Procedure-Related Complications by Timing of MIS (0-24 Hours vs 24-72 Hours)
Incidence of major procedure-related complications (e.g., postoperative rebleeding, surgical site infection, CSF leak, clinically significant seizures) during index hospitalization and through 30 days, compared between participants undergoing MIS within 0-24 hours versus 24-72 hours. Unit of Measure: Number of participants with ≥1 complication
Time frame
Within hospitalization and up to 30 days after intracerebral hemorrhageSponsors and contacts
Click on the lead sponsor to view all of their trials.
Huynh Quoc Huy
Lead sponsor
115 People's Hospital
Sponsor institution
Source ClinicalTrials.gov