Minimally Invasive Surgery for Spontaneous Deep Intracerebral Hemorrhage

Официальное название

Effectiveness and Safety of Minimally Invasive Surgery for Spontaneous Deep Intracerebral Hemorrhage: A Prospective and Retrospective Observational Cohort Study

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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.
• Другое 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.

Первичные конечные точки

• Functional Outcome by modified Rankin Scale (mRS) [Срок оценки: 180 days after symptom onset]
• Functional Outcome by Utility-Weighted modified Rankin Scale (UW-mRS) [Срок оценки: 180 days after symptom onset]
• Safety: All-Cause Mortality at 30 days [Срок оценки: 30 days after symptom onset]
• Safety: Change in Hematoma Volume (Δ volume) [Срок оценки: 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 [Срок оценки: From treatment initiation through 30 days after symptom onset]

Вторичные конечные точки (3)

• Functional Outcome According to Timing of Minimally Invasive Surgery (MIS) [Срок оценки: 180 days after symptom onset]
• Safety: All-Cause Mortality According to Timing of Minimally Invasive Surgery (MIS) [Срок оценки: 30 days after symptom onset]
• Safety: Treatment-Related Complications According to Timing of Minimally Invasive Surgery (MIS) [Срок оценки: From treatment initiation through 30 days after symptom onset]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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, S PMID 30739747
• 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. PMID 23726393
• 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- PMID 15680453
• 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 Remova PMID 38598795
• 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. PMID 20056489
• 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. PMID 40276373
• Sheth KN. Spontaneous Intracerebral Hemorrhage. N Engl J Med. 2022 Oct 27;387(17):1589-1596. doi: 10.1056/NEJMra2201449. No abstract available. PMID 36300975

Идентификаторы

NCT: NCT07710313 · ICH-115TA

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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