Intracerebral Hemorrhage Basal GangliaMISDIHNCT07234955
Minimally Invasive Surgery For Patients With Spontaneous Deep Intracerebral Hemorrhage
An observational study of Intracerebral Hemorrhage Basal Ganglia and Intracerebral Haemorrhage, run by Huynh Quoc Huy at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracerebral Hemorrhage Basal Ganglia, Intracerebral Haemorrhage
- How many people
- 300 participants
- Where
- 1 siteVietnam
- Study dates
- 8 Sep 2025to 1 Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
People's Hospital 115
Ho Chi Minh City, Ho Chi Minh, 700000
Huy Q Huynh, MD, +84 943054927, dr.huynhquochuy@gmail.com
About this study
Official title: Evaluation Of The Efficacy And Safety Of Minimally Invasive Surgery In Patients With Spontaneous Deep Intracerebral Hemorrhage
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.
Read the detailed description
Spontaneous deep intracerebral hemorrhage (ICH) is associated with high early mortality and long-term disability. Conventional craniotomy has not consistently improved functional outcomes, while medical management alone often results in poor prognosis. Minimally invasive surgery (MIS), including parafascicular approaches guided by neuronavigation, is designed to evacuate hematomas with reduced disruption of critical white-matter tracts. Evidence supporting MIS is more robust in lobar ICH, whereas data for basal ganglia hemorrhage remain limited. Furthermore, most prior studies restricted surgical intervention to within 24 hours from onset, leaving uncertainty regarding potential benefit when performed between 24 and 72 hours.
This prospective, multicenter, observational cohort study is conducted at People's Hospital 115 and Tam Anh General Hospital. Consecutive patients admitted with spontaneous basal ganglia ICH are enrolled within 72 hours of onset. Decisions regarding MIS, including whether to operate and the timing of surgery, are made by treating clinical teams in routine practice. The study does not assign interventions but documents real-world management and outcomes.
Data are captured prospectively using standardized CRFs and electronic CRFs. Information includes demographics, comorbidities, presenting neurological status, laboratory and imaging findings, details of MIS when performed, intensive care and hospital course, and follow-up assessments through 180 days. The primary endpoint is functional outcome at 180 days, while safety endpoints include mortality and treatment-related complications. Analyses are planned using prespecified multivariable approaches to account for confounding by indication. Additional subgroup analyses will assess outcomes by timing of MIS (0-24 vs 24-72 hours) and other clinically relevant variables.
By focusing on basal ganglia hemorrhage in contemporary Vietnamese stroke centers, this study is intended to generate real-world evidence on the effectiveness and safety of MIS in deep ICH and inform selection criteria and timing for future interventional trials.
- Keywords
- Deep Intracerebral Hemorrhage
- Medical subject headings
- Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Minimally Invasive Surgery | Patients with spontaneous deep intracerebral hemorrhage who undergo minimally invasive surgery according to clinical practice. | |
| Standard Medical Treatment | Patients with spontaneous deep intracerebral hemorrhage who receive conventional standard medical care according to clinical practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 180 days after intracerebral hemorrhage
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)
Measured: 180 days after intracerebral hemorrhage
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
Measured: 30 days after intracerebral hemorrhage
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
Measured: Within hospitalization and up to 30 days after intracerebral hemorrhage
Secondary outcomes (3)
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
Measured: 180 days after intracerebral hemorrhage
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.
Measured: 30 days after intracerebral hemorrhage
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
Measured: Within hospitalization and up to 30 days after intracerebral hemorrhage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start8 Sep 2025
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral Hemorrhage Basal GangliaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huynh Quoc Huy
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Huynh Quoc Huy, 115 People's Hospital
- Investigators
- Thang H Nguyen, MD, Ph, Study chair, People's Hospital 115, Ho Chi Minh City, Vietnam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07234955
- Sponsor's protocol ID
- CS/15/25/48
- Other IDs
- CS/15/25/48
- Acronym
- MISDIH
- Status last verified
- Nov 2025
- First submitted
- 25 Sep 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of The Efficacy And Safety Of Minimally Invasive Surgery In Patients With Spontaneous Deep Intracerebral Hemorrhage
- ClinicalTrials.gov ID
- NCT07234955
- Acronym / sponsor ID
- MISDIH / CS/15/25/48
- Keywords
- Deep Intracerebral Hemorrhage
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Huynh Quoc HuyOther government
- Study start
- 8 Sep 2025 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Spontaneous deep intracerebral hemorrhage (ICH) is associated with high early mortality and long-term disability. Conventional craniotomy has not consistently improved functional outcomes, while medical management alone often results in poor prognosis. Minimally invasive surgery (MIS), including parafascicular approaches guided by neuronavigation, is designed to evacuate hematomas with reduced disruption of critical white-matter tracts. Evidence supporting MIS is more robust in lobar ICH, whereas data for basal ganglia hemorrhage remain limited. Furthermore, most prior studies restricted surgical intervention to within 24 hours from onset, leaving uncertainty regarding potential benefit when performed between 24 and 72 hours.
This prospective, multicenter, observational cohort study is conducted at People's Hospital 115 and Tam Anh General Hospital. Consecutive patients admitted with spontaneous basal ganglia ICH are enrolled within 72 hours of onset. Decisions regarding MIS, including whether to operate and the timing of surgery, are made by treating clinical teams in routine practice. The study does not assign interventions but documents real-world management and outcomes.
Data are captured prospectively using standardized CRFs and electronic CRFs. Information includes demographics, comorbidities, presenting neurological status, laboratory and imaging findings, details of MIS when performed, intensive care and hospital course, and follow-up assessments through 180 days. The primary endpoint is functional outcome at 180 days, while safety endpoints include mortality and treatment-related complications. Analyses are planned using prespecified multivariable approaches to account for confounding by indication. Additional subgroup analyses will assess outcomes by timing of MIS (0-24 vs 24-72 hours) and other clinically relevant variables.
By focusing on basal ganglia hemorrhage in contemporary Vietnamese stroke centers, this study is intended to generate real-world evidence on the effectiveness and safety of MIS in deep ICH and inform selection criteria and timing for future interventional trials.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minimally Invasive Surgery | – | –Patients with spontaneous deep intracerebral hemorrhage who undergo minimally invasive surgery according to clinical practice. |
| Standard Medical Treatment | – | –Patients with spontaneous deep intracerebral hemorrhage who receive conventional standard medical care according to clinical practice. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary Outcome Measure 1 - Efficacy: Functional Outcome by Modified Rankin Scale (mRS)
Time frame: 180 days after intracerebral hemorrhage
Proportion of participants achieving favorable functional outcome defined as mRS 0-3. Unit of Measure: Percentage of participants
Primary Outcome Measure 2 - Efficacy: Functional Outcome by Utility-Weighted mRS (UW-mRS)
Time frame: 180 days after intracerebral hemorrhage
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)
Primary Outcome Measure 3 - Safety: All-Cause Mortality
Time frame: 30 days after intracerebral hemorrhage
Number of participants who die from any cause within 30 days after intracerebral hemorrhage. Unit of Measure: Percentage of participants
Primary Outcome Measure 4 - Safety: Procedure-Related Complications
Time frame: Within hospitalization and up to 30 days after intracerebral hemorrhage
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
3 secondary outcomes
Secondary Outcome Measure 1: Functional Outcome by Timing of MIS (0-24 Hours vs 24-72 Hours)
Time frame: 180 days after intracerebral hemorrhage
Secondary Outcome Measure 2: All-Cause Mortality at 30 Days by Timing of MIS (0-24 Hours vs 24-72 Hours)
Time frame: 30 days after intracerebral hemorrhage
Secondary Outcome Measure 3: Procedure-Related Complications by Timing of MIS (0-24 Hours vs 24-72 Hours)
Time frame: Within hospitalization and up to 30 days after intracerebral hemorrhage
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thang H Nguyen, MD, Ph study chair
People's Hospital 115, Ho Chi Minh City, Vietnam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracerebral Hemorrhage Basal Ganglia and Intracerebral Haemorrhage, run by Huynh Quoc Huy at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huy Q Huynh, MD (+84 943054927, dr.huynhquochuy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Measure 1 - Efficacy: Functional Outcome by Modified Rankin Scale (mRS) (time frame: 180 days after intracerebral hemorrhage). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.