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| Name | Class |
|---|---|
| Tam Anh TP. Ho Chi Minh General Hospital | OTHER |
| People's Hospital 115 | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minimally Invasive Surgery (MIS) | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) | 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 | 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) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huy Tan Chu, MD-PhD | Contact | +842839976276 | 1668 | huyct@tamri.vn |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30739747 | Background | 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. | |
| 23726393 |
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| ID | Term |
|---|---|
| D002543 | Cerebral Hemorrhage |
| D020145 | Basal Ganglia Hemorrhage |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D019060 | Minimally Invasive Surgical Procedures |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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|
| 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. |
|
| From treatment initiation through 30 days after symptom onset |
| 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 | 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 | From treatment initiation through 30 days after symptom onset |
| Background |
| Mendelow 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. |
| 15680453 | Background | Mendelow 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. |
| 38598795 | Background | Pradilla 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. |
| 20056489 | Background | van 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. |
| 40276373 | Background | Tran 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. |
| 36300975 | Background | Sheth KN. Spontaneous Intracerebral Hemorrhage. N Engl J Med. 2022 Oct 27;387(17):1589-1596. doi: 10.1056/NEJMra2201449. No abstract available. |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020144 | Basal Ganglia Cerebrovascular Disease |
| D001480 | Basal Ganglia Diseases |