Intracerebral HemorrhageMIS-DEEP ICHNCT07710313
Minimally Invasive Surgery for Spontaneous Deep Intracerebral Hemorrhage
An observational study of Intracerebral Hemorrhage and Spontaneous Intracerebral Hemorrhage, run by Tam Anh Research Institute.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracerebral Hemorrhage, Spontaneous Intracerebral Hemorrhage, Basal Ganglia Hemorrhage
- What is being tested?
- Minimally Invasive Surgery (MIS) and Standard medical treatment (SMT)
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 31 Dec 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: 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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effectiveness and Safety of Minimally Invasive Surgery for Spontaneous Deep Intracerebral Hemorrhage: A Prospective and Retrospective Observational Cohort Study
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.
Read the detailed description
Spontaneous deep intracerebral hemorrhage (ICH) is a severe neurological condition associated with high mortality and significant long-term disability. Outcomes remain unsatisfactory with standard medical management alone, and conventional craniotomy has not consistently demonstrated a functional benefit. Minimally invasive surgery (MIS), including neuronavigation-guided parafascicular techniques, has been introduced to achieve hematoma evacuation while minimizing damage to surrounding brain structures and subcortical white-matter tracts. While increasing evidence supports the use of MIS in lobar ICH, evidence in patients with basal ganglia hemorrhage remains limited. In addition, previous studies have largely focused on surgery performed within the first 24 hours of symptom onset, and the effectiveness of MIS performed in the extended 24-to-72-hour window remains uncertain.
This retrospective and prospective, multicenter, observational cohort study is being conducted at Tam Anh General Hospital and People's Hospital 115. The study consists of both retrospective and prospective cohorts. The retrospective cohort includes patients treated from November 2024 onward, following approval by the Ministry of Health for the robotic-assisted intracerebral hematoma evacuation procedure at Tam Anh General Hospital, Ho Chi Minh City, and continues through the present. The prospective cohort is planned to enroll patients from June 2026 to June 2028. Eligible participants include those presenting with spontaneous basal ganglia ICH within 72 hours of symptom onset.
Management decisions, including the indication for MIS and the timing of surgical intervention, are determined solely by the treating physicians according to routine clinical practice. No treatment allocation or intervention is dictated by this protocol; instead, the study evaluates real-world clinical practices and outcomes.
Data will be recorded using standardized case report forms and electronic case report forms (CRFs/eCRFs). Collected information includes patient demographics, comorbidities, neurological presentation, laboratory results, radiological characteristics, intraoperative details for patients undergoing MIS, intensive care management, hospital course, and follow-up evaluations. All participants will be followed for 180 days after treatment.
The primary outcome measure is functional status at 180 days. Safety outcomes include mortality and treatment-related adverse events. Prespecified multivariable analyses will be conducted to address potential confounding by indication. Subgroup analyses are planned to compare outcomes according to the timing of MIS (0-24 hours versus 24-72 hours) and other clinically relevant factors.
By evaluating patients with basal ganglia hemorrhage treated across specialized Vietnamese stroke centers, this study seeks to provide real-world evidence regarding the effectiveness and safety of MIS for deep ICH and to support future research on patient selection and optimal timing of intervention.
- Being tested
- Minimally Invasive Surgery (MIS), Standard medical treatment (SMT)
- Keywords
- Spontaneous Intracerebral Hemorrhage, Deep Intracerebral Hemorrhage, Basal Ganglia Hemorrhage, Minimally Invasive Surgery, Robotic-Assisted Surgery, Hematoma Evacuation
- Medical subject headings
- Cerebral Hemorrhage, Basal Ganglia Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally Invasive Surgery (MIS)Procedure or surgery
Patients 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
Participants 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.
| Study group | Role | What they receive |
|---|---|---|
| MIS Group | Participants with spontaneous deep intracerebral hemorrhage who receive standard medical treatment according to current clinical practice guidelines. Clinical and safety outcomes will be assessed through 180 days of follow-up. Receives: Procedure: Minimally Invasive Surgery (MIS) | |
| Standard Medical Treatment Group | Participants with spontaneous deep intracerebral hemorrhage who receive standard medical treatment according to current clinical practice guidelines. Clinical and safety outcomes will be assessed through 180 days of follow-up. Receives: Other: Standard medical treatment (SMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 180 days after symptom onset
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)
Measured: 180 days after symptom onset
Safety: All-Cause Mortality at 30 days
All-cause mortality within 30 days after symptom onset. Unit of Measure: Percentage of participants
Measured: 30 days after symptom onset
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)
Measured: Within 24 hours after MIS (MIS group) or within 6-36 hours after the baseline CT scan (standard medical treatment group)
Safety: Treatment-Related Complications
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.
Unit of Measure: Number of participants with one or more treatment-related complications
Measured: From treatment initiation through 30 days after symptom onset
Secondary outcomes (3)
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)
Measured: 180 days after symptom onset
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
Measured: 30 days after symptom onset
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
Measured: From treatment initiation through 30 days after symptom onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Intracerebral HemorrhageStudies 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
- Other
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tam Anh Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Tam Anh TP. Ho Chi Minh General Hospital, 115 People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07710313
- Sponsor's protocol ID
- ICH-115TA
- Acronym
- MIS-DEEP ICH
- Status last verified
- Jun 2026
- First submitted
- 18 Jun 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hanley DF, Thompson RE, Rosenblum M, Yenokyan G, Lane K, McBee N, Mayo SW, Bistran-Hall AJ, Gandhi D, Mould WA, Ullman N, Ali H, Carhuapoma JR, Kase CS, Lees KR, Dawson J, Wilson A, Betz JF, Sugar EA, Hao Y, Avadhani R, Caron JL, Harrigan MR, Carlson AP, Bulters D, LeDoux D, Huang J, Cobb C, Gupta G, Kitagawa R, Chicoine MR, Patel H, Dodd R, Camarata PJ, Wolfe S, Stadnik A, Money PL, Mitchell P, Sarabia R, Harnof S, Barzo P, Unterberg A, Teitelbaum JS, Wang W, Anderson CS, Mendelow AD, Gregson B, Janis S, Vespa P, Ziai W, Zuccarello M, Awad IA; MISTIE III Investigators. Efficacy and safety of minimally invasive surgery with thrombolysis in intracerebral haemorrhage evacuation (MISTIE III): a randomised, controlled, open-label, blinded endpoint phase 3 trial. Lancet. 2019 Mar 9;393(10175):1021-1032. doi: 10.1016/S0140-6736(19)30195-3. Epub 2019 Feb 7.
PubMed 30739747Mendelow AD, Gregson BA, Rowan EN, Murray GD, Gholkar A, Mitchell PM; STICH II Investigators. Early surgery versus initial conservative treatment in patients with spontaneous supratentorial lobar intracerebral haematomas (STICH II): a randomised trial. Lancet. 2013 Aug 3;382(9890):397-408. doi: 10.1016/S0140-6736(13)60986-1. Epub 2013 May 29.
PubMed 23726393Mendelow AD, Gregson BA, Fernandes HM, Murray GD, Teasdale GM, Hope DT, Karimi A, Shaw MD, Barer DH; STICH investigators. Early surgery versus initial conservative treatment in patients with spontaneous supratentorial intracerebral haematomas in the International Surgical Trial in Intracerebral Haemorrhage (STICH): a randomised trial. Lancet. 2005 Jan 29-Feb 4;365(9457):387-97. doi: 10.1016/S0140-6736(05)17826-X.
PubMed 15680453Pradilla G, Ratcliff JJ, Hall AJ, Saville BR, Allen JW, Paulon G, McGlothlin A, Lewis RJ, Fitzgerald M, Caveney AF, Li XT, Bain M, Gomes J, Jankowitz B, Zenonos G, Molyneaux BJ, Davies J, Siddiqui A, Chicoine MR, Keyrouz SG, Grossberg JA, Shah MV, Singh R, Bohnstedt BN, Frankel M, Wright DW, Barrow DL; ENRICH trial investigators; ENRICH Trial Investigators. Trial of Early Minimally Invasive Removal of Intracerebral Hemorrhage. N Engl J Med. 2024 Apr 11;390(14):1277-1289. doi: 10.1056/NEJMoa2308440.
PubMed 38598795van Asch CJ, Luitse MJ, Rinkel GJ, van der Tweel I, Algra A, Klijn CJ. Incidence, case fatality, and functional outcome of intracerebral haemorrhage over time, according to age, sex, and ethnic origin: a systematic review and meta-analysis. Lancet Neurol. 2010 Feb;9(2):167-76. doi: 10.1016/S1474-4422(09)70340-0. Epub 2010 Jan 5.
PubMed 20056489Tran MC, Prisco L, Pham PM, Phan HQ, Ganau M, Pham N, Truong LH, Ariana P, Dao PV, Nguyen DT, Van Nguyen C, Truong HT, Nguyen TH, Pandian J, Mai TD, Farmery A. Comprehensive analysis of stroke epidemiology in Vietnam: Insights from GBD 1990-2019 and RES-Q 2017-2023. Glob Epidemiol. 2025 Apr 10;9:100199. doi: 10.1016/j.gloepi.2025.100199. eCollection 2025 Jun.
PubMed 40276373Sheth KN. Spontaneous Intracerebral Hemorrhage. N Engl J Med. 2022 Oct 27;387(17):1589-1596. doi: 10.1056/NEJMra2201449. No abstract available.
PubMed 36300975
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Minimally Invasive Surgery for Spontaneous Deep Intracerebral Hemorrhage: A Prospective and Retrospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07710313
- Acronym / sponsor ID
- MIS-DEEP ICH / ICH-115TA
- Keywords
- Spontaneous Intracerebral Hemorrhage, Deep Intracerebral Hemorrhage, Basal Ganglia Hemorrhage, Minimally Invasive Surgery, Robotic-Assisted Surgery, Hematoma Evacuation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Tam Anh Research InstituteUniversity, hospital or other
- Collaborators
- Tam Anh TP. Ho Chi Minh General Hospital, 115 People's Hospital
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 17 Jul 2026 (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 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.
Detailed description
Spontaneous deep intracerebral hemorrhage (ICH) is a severe neurological condition associated with high mortality and significant long-term disability. Outcomes remain unsatisfactory with standard medical management alone, and conventional craniotomy has not consistently demonstrated a functional benefit. Minimally invasive surgery (MIS), including neuronavigation-guided parafascicular techniques, has been introduced to achieve hematoma evacuation while minimizing damage to surrounding brain structures and subcortical white-matter tracts. While increasing evidence supports the use of MIS in lobar ICH, evidence in patients with basal ganglia hemorrhage remains limited. In addition, previous studies have largely focused on surgery performed within the first 24 hours of symptom onset, and the effectiveness of MIS performed in the extended 24-to-72-hour window remains uncertain.
This retrospective and prospective, multicenter, observational cohort study is being conducted at Tam Anh General Hospital and People's Hospital 115. The study consists of both retrospective and prospective cohorts. The retrospective cohort includes patients treated from November 2024 onward, following approval by the Ministry of Health for the robotic-assisted intracerebral hematoma evacuation procedure at Tam Anh General Hospital, Ho Chi Minh City, and continues through the present. The prospective cohort is planned to enroll patients from June 2026 to June 2028. Eligible participants include those presenting with spontaneous basal ganglia ICH within 72 hours of symptom onset.
Management decisions, including the indication for MIS and the timing of surgical intervention, are determined solely by the treating physicians according to routine clinical practice. No treatment allocation or intervention is dictated by this protocol; instead, the study evaluates real-world clinical practices and outcomes.
Data will be recorded using standardized case report forms and electronic case report forms (CRFs/eCRFs). Collected information includes patient demographics, comorbidities, neurological presentation, laboratory results, radiological characteristics, intraoperative details for patients undergoing MIS, intensive care management, hospital course, and follow-up evaluations. All participants will be followed for 180 days after treatment.
The primary outcome measure is functional status at 180 days. Safety outcomes include mortality and treatment-related adverse events. Prespecified multivariable analyses will be conducted to address potential confounding by indication. Subgroup analyses are planned to compare outcomes according to the timing of MIS (0-24 hours versus 24-72 hours) and other clinically relevant factors.
By evaluating patients with basal ganglia hemorrhage treated across specialized Vietnamese stroke centers, this study seeks to provide real-world evidence regarding the effectiveness and safety of MIS for deep ICH and to support future research on patient selection and optimal timing of intervention.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MIS Group | – | Procedure: Minimally Invasive Surgery (MIS)Participants with spontaneous deep intracerebral hemorrhage who receive standard medical treatment according to current clinical practice guidelines. Clinical and safety outcomes will be assessed through 180 days of follow-up. |
| Standard Medical Treatment Group | – | Other: Standard medical treatment (SMT)Participants with spontaneous deep intracerebral hemorrhage who receive standard medical treatment according to current clinical practice guidelines. Clinical and safety outcomes will be assessed through 180 days of follow-up. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minimally Invasive Surgery (MIS)Patients 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. | Procedure or surgery | MIS Group |
| Standard medical treatment (SMT)Participants 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. | Other | Standard Medical Treatment Group |
Primary outcome
Functional Outcome by modified Rankin Scale (mRS)
Time frame: 180 days after symptom onset
Proportion of participants with a favorable functional outcome, defined as mRS score of 0 to 3. Unit of Measure: Percentage of participants.
Functional Outcome by Utility-Weighted modified Rankin Scale (UW-mRS)
Time frame: 180 days after symptom onset
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)
Safety: All-Cause Mortality at 30 days
Time frame: 30 days after symptom onset
All-cause mortality within 30 days after symptom onset. Unit of Measure: Percentage of participants
Safety: Change in Hematoma Volume (Δ volume)
Time frame: Within 24 hours after MIS (MIS group) or within 6-36 hours after the baseline CT scan (standard medical treatment group)
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)
Safety: Treatment-Related Complications
Time frame: From treatment initiation through 30 days after symptom onset
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. Unit of Measure: Number of participants with one or more treatment-related complications
3 secondary outcomes
Functional Outcome According to Timing of Minimally Invasive Surgery (MIS)
Time frame: 180 days after symptom onset
Safety: All-Cause Mortality According to Timing of Minimally Invasive Surgery (MIS)
Time frame: 30 days after symptom onset
Safety: Treatment-Related Complications According to Timing of Minimally Invasive Surgery (MIS)
Time frame: From treatment initiation through 30 days after symptom onset
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 30 Sep 2026.
- Background: PubMed 30739747Hanley DF, Thompson RE, Rosenblum M, Yenokyan G, Lane K, McBee N, Mayo SW, Bistran-Hall AJ, Gandhi D, Mould WA, Ullman N, Ali H, Carhuapoma JR, Kase CS, Lees KR, Dawson J, Wilson A, Betz JF, Sugar EA, Hao Y, Avadhani R, Caron JL, Harrigan MR, Carlson AP, Bulters D, LeDoux D, Huang J, Cobb C, Gupta G, Kitagawa R, Chicoine MR, Patel H, Dodd R, Camarata PJ, Wolfe S, Stadnik A, Money PL, Mitchell P, Sarabia R, Harnof S, Barzo P, Unterberg A, Teitelbaum JS, Wang W, Anderson CS, Mendelow AD, Gregson B, Janis S, Vespa P, Ziai W, Zuccarello M, Awad IA; MISTIE III Investigators. Efficacy and safety of minimally invasive surgery with thrombolysis in intracerebral haemorrhage evacuation (MISTIE III): a randomised, controlled, open-label, blinded endpoint phase 3 trial. Lancet. 2019 Mar 9;393(10175):1021-1032. doi: 10.1016/S0140-6736(19)30195-3. Epub 2019 Feb 7.
- Background: PubMed 23726393Mendelow AD, Gregson BA, Rowan EN, Murray GD, Gholkar A, Mitchell PM; STICH II Investigators. Early surgery versus initial conservative treatment in patients with spontaneous supratentorial lobar intracerebral haematomas (STICH II): a randomised trial. Lancet. 2013 Aug 3;382(9890):397-408. doi: 10.1016/S0140-6736(13)60986-1. Epub 2013 May 29.
- Background: PubMed 15680453Mendelow AD, Gregson BA, Fernandes HM, Murray GD, Teasdale GM, Hope DT, Karimi A, Shaw MD, Barer DH; STICH investigators. Early surgery versus initial conservative treatment in patients with spontaneous supratentorial intracerebral haematomas in the International Surgical Trial in Intracerebral Haemorrhage (STICH): a randomised trial. Lancet. 2005 Jan 29-Feb 4;365(9457):387-97. doi: 10.1016/S0140-6736(05)17826-X.
- Background: PubMed 38598795Pradilla G, Ratcliff JJ, Hall AJ, Saville BR, Allen JW, Paulon G, McGlothlin A, Lewis RJ, Fitzgerald M, Caveney AF, Li XT, Bain M, Gomes J, Jankowitz B, Zenonos G, Molyneaux BJ, Davies J, Siddiqui A, Chicoine MR, Keyrouz SG, Grossberg JA, Shah MV, Singh R, Bohnstedt BN, Frankel M, Wright DW, Barrow DL; ENRICH trial investigators; ENRICH Trial Investigators. Trial of Early Minimally Invasive Removal of Intracerebral Hemorrhage. N Engl J Med. 2024 Apr 11;390(14):1277-1289. doi: 10.1056/NEJMoa2308440.
- Background: PubMed 20056489van Asch CJ, Luitse MJ, Rinkel GJ, van der Tweel I, Algra A, Klijn CJ. Incidence, case fatality, and functional outcome of intracerebral haemorrhage over time, according to age, sex, and ethnic origin: a systematic review and meta-analysis. Lancet Neurol. 2010 Feb;9(2):167-76. doi: 10.1016/S1474-4422(09)70340-0. Epub 2010 Jan 5.
- Background: PubMed 40276373Tran MC, Prisco L, Pham PM, Phan HQ, Ganau M, Pham N, Truong LH, Ariana P, Dao PV, Nguyen DT, Van Nguyen C, Truong HT, Nguyen TH, Pandian J, Mai TD, Farmery A. Comprehensive analysis of stroke epidemiology in Vietnam: Insights from GBD 1990-2019 and RES-Q 2017-2023. Glob Epidemiol. 2025 Apr 10;9:100199. doi: 10.1016/j.gloepi.2025.100199. eCollection 2025 Jun.
- Background: PubMed 36300975Sheth KN. Spontaneous Intracerebral Hemorrhage. N Engl J Med. 2022 Oct 27;387(17):1589-1596. doi: 10.1056/NEJMra2201449. No abstract available.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracerebral Hemorrhage and Spontaneous Intracerebral Hemorrhage, run by Tam Anh Research Institute.
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: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Tan Chu, MD-PhD (+842839976276 ext. 1668, huyct@tamri.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Outcome by modified Rankin Scale (mRS) (time frame: 180 days after symptom onset). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07710313, which also lists 7 linked publications.
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 30 Sep 2026.