International journal of stroke : official journal of the International Stroke Society · 2024
Efficacy and safety of NeuroEndoscopic Surgery for IntraCerebral Hemorrhage: A randomized, controlled, open-label, blinded endpoint trial (NESICH).
Протокол клинического исследованияСтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Wang Long, Zhou Tengyuan, Wang Pangbo, Zhang Shuixian, Yin Yi, Chen Lin, Duan Haijun, Wu Na, Feng Hua, Hu Rong
Аннотация
BACKGROUND: Neuroendoscopy is a minimally invasive procedure for clot evacuation in intracerebral hemorrhage (ICH) which may have advantages compared with open surgical evacuation procedures. The application of neuroendoscopy in ICH has attracted increasing attention in recent years. However, it remains unclear whether it could improve outcomes in patients with ICH.
OBJECTIVE: The aim of this study is to explore the efficacy and safety of neuroendoscopic hematoma evacuation surgery compared with standard conservative treatment for spontaneous deep supratentorial cerebral hemorrhage.
METHODS: The Efficacy and safety of NeuroEndoscopic Surgery for IntraCerebral Hemorrhage (NESICH) Trial is a multicenter, randomized, controlled, open-label, blinded-endpoint clinical trial. Up to 560 eligible subjects with acute deep supratentorial ICH will be randomly assigned (1:1) to receive either neuroendoscopic hematoma evacuation or standard conservative treatment at more than 30 qualified neurosurgery centers in China.
OUTCOMES: The primary endpoint is the proportion of patients with a good functional outcome (mRS score 0-3) in both groups at 180 days after onset. The main safety endpoints include all-cause mortality at 7, 30, and 180 days, rebleeding at 3, 7, and 30 days, and serious complications within 180 days.
DISCUSSION: NESICH will provide high-quality evidence for the efficacy and safety of neuroendoscopic hematoma evacuation surgery in ICH patients.
TRIAL REGISTRATION: ClinicalTrials.gov NCT05539859.
OBJECTIVE: The aim of this study is to explore the efficacy and safety of neuroendoscopic hematoma evacuation surgery compared with standard conservative treatment for spontaneous deep supratentorial cerebral hemorrhage.
METHODS: The Efficacy and safety of NeuroEndoscopic Surgery for IntraCerebral Hemorrhage (NESICH) Trial is a multicenter, randomized, controlled, open-label, blinded-endpoint clinical trial. Up to 560 eligible subjects with acute deep supratentorial ICH will be randomly assigned (1:1) to receive either neuroendoscopic hematoma evacuation or standard conservative treatment at more than 30 qualified neurosurgery centers in China.
OUTCOMES: The primary endpoint is the proportion of patients with a good functional outcome (mRS score 0-3) in both groups at 180 days after onset. The main safety endpoints include all-cause mortality at 7, 30, and 180 days, rebleeding at 3, 7, and 30 days, and serious complications within 180 days.
DISCUSSION: NESICH will provide high-quality evidence for the efficacy and safety of neuroendoscopic hematoma evacuation surgery in ICH patients.
TRIAL REGISTRATION: ClinicalTrials.gov NCT05539859.