Efficacy and Safety of NeuroEndoscopic Surgery for Large IntraCerebral Hemorrhage

Official title

Efficacy and Safety of NeuroEndoscopic Surgery for Large IntraCerebral Hemorrhage: a Multicenter, Randomized, Controlled Clinical Trial

Overview

This is a multicenter, randomized, controlled clinical trial comparing neuroendoscopic hematoma removal to craniotomy in the treatment of large intracerebral hemorrhage.

Detailed description

Previous retrospective studies have demonstrated that neuroendoscopic surgery, compared to conventional craniotomy, significantly reduces operative duration and intraoperative blood loss, enhances hematoma evacuation rates, and improves postoperative outcomes, including neurological recovery, activities of daily living, and quality of life in patients with large cerebral hemorrhage. However, there is a paucity of prospective randomized controlled trials evaluating the efficacy of different surgical techniques for intracerebral hemorrhage. To address this gap, the investigators propose a multicenter, randomized, controlled clinical trial to compare the safety and efficacy of neuroendoscopic surgery versus craniotomy, aiming to provide evidence-based guidance for surgical decision-making in cerebral hemorrhage management.

Interventions

• Procedure neuroendoscopic surgery
  Subjects will receive Neuroendoscopic Surgery followed by standard medical management
• Procedure craniotomy
  Subjects will receive Craniotomy followed by standard medical management

Primary outcome measures

• The proportion of patients with Modified Rankin Scale (mRS) score 0-3 [Time frame: 180 days]

Secondary outcome measures (11)

• Modified Rankin Scale (mRS) Score [Time frame: 180 days]
• mortality [Time frame: 30 days, 90 days and 180 days]
• Glasgow Outcome Scale Extended (GOS-E) [Time frame: 180 days]
• Assessment of cognitive function with Mini-Mental State Examination (MMSE) [Time frame: 90 days and 180 days]
• Quality of life measured with the 5-level EQ-5D (EQ-5D-5L) [Time frame: 30 days and 180 days]
• The proportion of patients with Modified Rankin Scale (mRS) score 0-2 [Time frame: 180 days]
• Length of ICU [Time frame: Number of days from admission, up to 180 days]
• Length of hospitalization [Time frame: Number of days from admission to discharge, up to 180 days]
• The proportion of patients with Modified Rankin Scale (mRS) score 0-3 [Time frame: 30 days and 90 days]
• Operation duration [Time frame: From the beginning to the end of the surgery]
• Peroperative bleeding [Time frame: During surgery]

Eligibility criteria

Inclusion criteria

• Age 18-80 years old, male or female;
• The time between onset and admission to the first diagnostic CT is within 24 hours (for no bystanders and the time of onset is unknown, the time of the last known patient in good condition is used);
• Patients with supratentorial intracerebral hemorrhage (supratentorial intracerebral hemorrhage (supratentorial intracerebral hemorrhage) whose hematoma volume is ≥50ml or whose hematoma produces obvious space occupying effect and requires emergency surgery (including patients with cerebral hernia signs such as retarding or dilatation of light reflex of one pupil);
• Before randomization, GCS score was 5-14, NIHSS score was ≥6;
• mRS Before onset: 0-1 score;
• Randomization within 24 hours after the first diagnostic CT;
• The patient or family members are informed and voluntarily sign the informed consent;

Exclusion criteria

• The clinical diagnosis is caused by cerebral aneurysm, cerebrovascular malformation, moyamoya disease, brain trauma, brain tumor, massive cerebral infarction hemorrhage transformation, coagulation dysfunction, etc.;
• Thalamic hemorrhage, primary ventricular hemorrhage;
• Platelet count <100×109/L, INR > 1.4;
• Patients with advanced cerebral hernia (such as dilated bifidus and no light reflex) or unstable vital signs cannot tolerate surgery;
• Irreversible brain stem impairment (eye fixation, bilateral pupil dilation), GCS≤4 points;
• Any history of parenchyma or other intracranial subarachnoid, subdural or epidural blood and surgical history in the past 30 days;
• Patients with severe advanced cognitive impairment (such as AD) or who are not expected to complete the follow-up plan as required;
• Complicated with other serious diseases: including respiratory, circulation, digestion, urinary, endocrine, immune and blood systems;
• Pregnant or breastfeeding women, or those who expect to become pregnant within one year;
• are participating in other clinical trials (excluding: observational studies that do not involve intervention, natural history and/or epidemiological studies).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 2 centers

• Southwest Hospital — Chongqing
• Dazhu County People's Hospital — Dazhou

Publications

• Beck J, Fung C, Strbian D, Butikofer L, Z'Graggen WJ, Lang MF, Beyeler S, Gralla J, Ringel F, Schaller K, Plesnila N, Arnold M, Hacke W, Juni P, Mendelow AD, Stapf C, Al-Shahi Salman R, Bressan J, Lerch S, Hakim A, Martinez-Majander N, Piippo-Karjalainen A, Vajkoczy P, Wolf S, Schubert GA, Hollig A, Veldeman M, Roelz R, Gruber A, Rauch P, Mielke D, Rohde V, Kerz T, Uhl E, Thanasi E, Huttner HB, Ka PMID 38761811
• 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
• Correction to: ICES (Intraoperative Stereotactic Computed Tomography-Guided Endoscopic Surgery) for Brain Hemorrhage: A Multicenter Randomized Controlled Trial. Stroke. 2017 Nov;48(11):e335. doi: 10.1161/STR.0000000000000153. No abstract available. PMID 29061841
• 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
• Greenberg SM, Ziai WC, Cordonnier C, Dowlatshahi D, Francis B, Goldstein JN, Hemphill JC 3rd, Johnson R, Keigher KM, Mack WJ, Mocco J, Newton EJ, Ruff IM, Sansing LH, Schulman S, Selim MH, Sheth KN, Sprigg N, Sunnerhagen KS; American Heart Association/American Stroke Association. 2022 Guideline for the Management of Patients With Spontaneous Intracerebral Hemorrhage: A Guideline From the American PMID 35579034
• Hemphill JC 3rd, Greenberg SM, Anderson CS, Becker K, Bendok BR, Cushman M, Fung GL, Goldstein JN, Macdonald RL, Mitchell PH, Scott PA, Selim MH, Woo D; American Heart Association Stroke Council; Council on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology. Guidelines for the Management of Spontaneous Intracerebral Hemorrhage: A Guideline for Healthcare Professionals From the Ameri PMID 26022637
• 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
• Teo KC, Fong SM, Leung WCY, Leung IYH, Wong YK, Choi OMY, Yam KK, Lo RCN, Cheung RTF, Ho SL, Tsang ACO, Leung GKK, Chan KH, Lau KK. Location-Specific Hematoma Volume Cutoff and Clinical Outcomes in Intracerebral Hemorrhage. Stroke. 2023 Jun;54(6):1548-1557. doi: 10.1161/STROKEAHA.122.041246. Epub 2023 May 22. PMID 37216445

Identifiers

NCT: NCT06894433 · Neurosurg 05

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗