Minimally Invasive Surgery for Spontaneous Deep Intracerebral Hemorrhage

NCT07710313 | Not Yet Recruiting DMC

• 1 other identifier: ICH-115TA
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Intracerebral Hemorrhage; Spontaneous Intracerebral Hemorrhage; Basal Ganglia Hemorrhage

Keywords

Spontaneous Intracerebral Hemorrhage; Deep Intracerebral Hemorrhage; Basal Ganglia Hemorrhage; Minimally Invasive Surgery; Robotic-Assisted Surgery; Hematoma Evacuation

Outcome Measures

Primary Outcomes (5)

• 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

  From treatment initiation through 30 days after symptom onset

Secondary Outcomes (3)

• Functional Outcome According to Timing of Minimally Invasive Surgery (MIS)

  180 days after symptom onset

• Safety: All-Cause Mortality According to Timing of Minimally Invasive Surgery (MIS)

  30 days after symptom onset

• Safety: Treatment-Related Complications According to Timing of Minimally Invasive Surgery (MIS)

  From treatment initiation through 30 days after symptom onset

Study Arms (2)

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.

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.

Other: Standard medical treatment (SMT)

Interventions

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.

MIS Group

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.

Standard Medical Treatment Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tam Anh Research Institute: lead
• Tam Anh TP. Ho Chi Minh General Hospital: collaborator
• People's Hospital 115: collaborator

Related Publications (7)

• 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.

  PMID: 30739747 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.

  PMID: 23726393 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.

  PMID: 15680453 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.

  PMID: 38598795 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.

  PMID: 20056489 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.

  PMID: 40276373 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Cerebral Hemorrhage; Basal Ganglia Hemorrhage

Interventions

Minimally Invasive Surgical Procedures

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Basal Ganglia Cerebrovascular Disease; Basal Ganglia Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Central Study Contacts

Huy Tan Chu, MD-PhD

CONTACT

+842839976276; huyct@tamri.vn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: July 17, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 17, 2026

Record last verified: 2026-06