Efficacy and Safety of NeuroEndoscopic Surgery for IntraCerebral Hemorrhage

Официальное название

Efficacy and Safety of NeuroEndoscopic Surgery for IntraCerebral Hemorrhage: a Randomised, Controlled, Open-label, Blinded Endpoint Trial

Обзор

To compare the efficacy and safety of neuroendoscopic hematoma removal and standard conservative treatment for patients with spontaneous supratentorial deep intracerebral hemorrhage.

Подробное описание

Neuroendoscopic treatment of spontaneous intracerebral hemorrhage (ICH) is more and more widely used, but multi-center clinical study on the efficacy and safety of neuroendoscopic treatment of ICH is relatively small. Based on the lack of sufficient clinical evidence, the investigators plan to conduct a prospective, multicenter, randomized controlled clinical trial to investigate the safety and efficacy of neuroendoscopy in the treatment of spontaneous cerebral parenchymal hemorrhage, so as to provide evidence-based medical evidence for endoscopic minimally invasive treatment of cerebral hemorrhage and its application.The aim of trial was to determine whether the endoscopic surgery could achieve the benefits of clot evacuation and improve functional outcome at 180 days after ICH without procedure-related safety events or additional brain injury beyond the risks associated with standard care

Вмешательства

• Процедура Endoscopic surgery
  Subjects will receive surgical hematoma evacuation using neuroendoscope, followed by medical management
• Другое Medical management
  Subjects will initially receive the standard medical therapies for the treatment of intracerebral hemorrhage, according to the latest available guideline.

Первичные конечные точки

• The proportion of patients with Modified Rankin Scale (mRS) score 0-3 [Срок оценки: 180 days]
• Safety outcome [Срок оценки: 180 days]

Вторичные конечные точки (12)

• Glasgow Outcome Scale Extended (GOS-E) [Срок оценки: 30 days.]
• Glasgow Outcome Scale Extended (GOS-E) [Срок оценки: 90 days.]
• Glasgow Outcome Scale Extended (GOS-E) [Срок оценки: 180 days.]
• Modified Rankin Scale (mRS) Score [Срок оценки: 30 days.]
• Modified Rankin Scale (mRS) Score [Срок оценки: 90 days .]
• Survival rate [Срок оценки: 30 days.]
• Survival rate [Срок оценки: 90 days.]
• Assessment of cognitive function with Mini-Mental State Examination (MMSE) [Срок оценки: 30 days.]
• Assessment of cognitive function with Mini-Mental State Examination (MMSE) [Срок оценки: 90 days.]
• Assessment of cognitive function with Mini-Mental State Examination (MMSE) [Срок оценки: 180 days.]
• Quality of life measured with the 5-level EQ-5D (EQ-5D-5L) [Срок оценки: 30 days.]
• Quality of life measured with the 5-level EQ-5D (EQ-5D-5L) [Срок оценки: 90 days.]

Критерии участия

Критерии включения

• Age 18-80 years, either sex.
• Time from onset to the first diagnostic CT within 24 hours (for those without bystanders and with unknown onset time, use the last known time the patient was in good condition)
• Deep (external capsule, putamen, internal capsule, caudate nucleus) supratentorial cerebral hemorrhage with a hematoma volume ≥ 25 ml.
• Stability of the hematoma determined by two CT scans at different times after onset. If the hematoma enlarges 5ml then the stability of the hematoma can be detected by CT again after 6 hours until the randomization time window is closed.
• Pre-randomization GCS score of 5-14 and/or NIHSS score of ≥6.
• Pre-onset Modified Rankin Scale (mRS) score 0 or 1.
• Blood pressure recorded 6 hours prior to randomization consistently controlled at 180 mmHg or less.
• Randomization completed within 24 hours after the first diagnostic CT, and surgical intervention should be performed as soon as possible, no later than 6 hours after randomization, that is to say, surgery should be performed no later than 54 hours after onset.
• Informed and voluntarily signed informed consent by the patient or family.

Критерии исключения

• Hemorrhage clinically diagnosed as a result of cerebral aneurysm, cerebrovascular malformation, moyamoya disease, traumatic brain injury, brain tumor, hemorrhagic transformation of a large cerebral infarct, coagulation dysfunction.
• Lobar hemorrhages, thalamic hemorrhages, primary ventricular hemorrhages, cerebellum hemorrhages and brain stem hemorrhages.
• Hematoma involving the midbrain, with dilated or unresponsive pupils.
• Hematoma producing life-threatening occupying effects (e.g., CT showing midline deviation of more than 1 cm, loss of cisterna ambiens) or patients who are extremely unstable and unfit for enrollment.
• Platelet count <100×10\^9/L, international normalized ratio (INR) >1.4.
• Hematoma extension to ventricle and completely blocked the third or fourth ventricle.
• Recent history of cerebral hemorrhage (less than 1 year).
• Severe hepatic impairment with ALT 3 times the upper limit of normal, or AST 3 times the upper limit of normal. Severe renal insufficiency with glomerular filtration rate less than 30 ml/min/1.73 m2.
• Blood pressure not effectively controlled to less than 180 mmHg despite aggressive antihypertensive therapy prior to randomization.
• Patients with severe advanced cognitive impairment (e.g. AD) or psychiatric disorders who are unable to complete the follow-up program as required.
• Comorbid other serious diseases such as respiratory, circulatory, digestive, urological, endocrine, immune and hematologic disorders.
• Pregnant or lactating women, or those who expect to become pregnant within one year.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 4 центра

• chongqing Emergency Medical Center — Чунцин
• Xiang Yang NO.1 Peoples Hospital — Hubei
• Dazhu County People's Hospital — Sichuan
• Ganzhou city people's Hospita — Ganzhou

Публикации

• Hansen BM, Ullman N, Muschelli J, Norrving B, Dlugash R, Avadhani R, Awad I, Zuccarello M, Ziai WC, Hanley DF, Thompson RE, Lindgren A; MISTIE and CLEAR Investigators. Relationship of White Matter Lesions with Intracerebral Hemorrhage Expansion and Functional Outcome: MISTIE II and CLEAR III. Neurocrit Care. 2020 Oct;33(2):516-524. doi: 10.1007/s12028-020-00916-4. PMID 32026447
• de Oliveira Manoel AL. Surgery for spontaneous intracerebral hemorrhage. Crit Care. 2020 Feb 7;24(1):45. doi: 10.1186/s13054-020-2749-2. PMID 32033578
• Anderson CD, James ML. Survival and independence after intracerebral hemorrhage: Trends and opportunities. Neurology. 2018 Jun 5;90(23):1043-1044. doi: 10.1212/WNL.0000000000005625. Epub 2018 May 4. No abstract available. PMID 29728523
• Kuo LT, Chen CM, Li CH, Tsai JC, Chiu HC, Liu LC, Tu YK, Huang AP. Early endoscope-assisted hematoma evacuation in patients with supratentorial intracerebral hemorrhage: case selection, surgical technique, and long-term results. Neurosurg Focus. 2011 Apr;30(4):E9. doi: 10.3171/2011.2.FOCUS10313. PMID 21456936
• Kellner CP, Song R, Pan J, Nistal DA, Scaggiante J, Chartrain AG, Rumsey J, Hom D, Dangayach N, Swarup R, Tuhrim S, Ghatan S, Bederson JB, Mocco J. Long-term functional outcome following minimally invasive endoscopic intracerebral hemorrhage evacuation. J Neurointerv Surg. 2020 May;12(5):489-494. doi: 10.1136/neurintsurg-2019-015528. Epub 2020 Jan 8. PMID 31915207
• Xu X, Chen X, Li F, Zheng X, Wang Q, Sun G, Zhang J, Xu B. Erratum. Effectiveness of endoscopic surgery for supratentorial hypertensive intracerebral hemorrhage: a comparison with craniotomy. J Neurosurg. 2018 Feb;128(2):649. doi: 10.3171/2017.5.JNS161589a. Epub 2017 Jul 28. No abstract available. PMID 28753114
• Wang L, Zhou T, Wang P, Zhang S, Yin Y, Chen L, Duan H, Wu N, Feng H, Hu R. Efficacy and safety of NeuroEndoscopic Surgery for IntraCerebral Hemorrhage: A randomized, controlled, open-label, blinded endpoint trial (NESICH). Int J Stroke. 2024 Jun;19(5):587-592. doi: 10.1177/17474930241232292. Epub 2024 Feb 19. PMID 38291017

Идентификаторы

NCT: NCT05539859 · (A)KY2022103

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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