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Registration Study for the Prevention and Treatment of Cerebral Hemorrhage using Naoxueshu Oral Liquid: Protocol for a Research Study
Journal of Stroke & Cerebrovascular Diseases ( IF 2.5 ) Pub Date : 2024-02-25 , DOI: 10.1016/j.jstrokecerebrovasdis.2024.107649
Kexin Wang , Yuanyuan Chen , Qingwen Geng , Jinjuan Dou , Dahe Qi , Weidong Zhu , Lianying Song , Jingpei Wei , Mengmeng Ding , Yunlong Hao , Lingbo Kong , Ying Gao

: Naoxueshu oral liquid is the only approved drug for acute treatment of cerebral hemorrhage in China. It has been used widely for the treatment of acute ischemic stroke and acute hemorrhagic stroke. However, safety and efficacy data on the early use of Naoxueshu oral liquid are lacking. The main purpose of this study is to observe the benefit and safety of early use of Naoxueshu oral liquid (< 72 h of cerebral hemorrhage) and offer evidence into the potential superiority of Naoxueshu oral liquid in patients with hemorrhagic stroke, and its healthcare costs. This registration study for the prevention and treatment of cerebral hemorrhage using Naoxueshu oral liquid will be a quantitative, prospective, multicenter, observational clinical registry study. We aim to register 2000 patients with cerebral hemorrhage within 7 days of disease onset. This study will be an observational study and not interfere with the medication regimen of participants. Hence, we will not allocate patients. The main observation indicators will be the hematoma volume and the proportion of reduction 14 days post-cerebral hemorrhage (or at hospital discharge), onset of new stroke (ischemic stroke, hemorrhagic stroke) within 12 months of disease onset, independence in everyday life activities (modified Rankin Scale score ≤ 2), total cost during hospitalization, and treatment costs. This registration study will offer strong evidence for the efficacy and safety of Naoxueshu oral liquid for the prevention and treatment of cerebral hemorrhage, particularly with regard to early use (72 h after onset). It will offer evidence into the potential advantages of Naoxueshu oral liquid in patients with hemorrhagic stroke, including healthcare costs.

中文翻译:

脑血舒口服液防治脑出血的注册研究:研究方案

:脑血舒口服液是国内唯一批准用于急性脑出血治疗的药物。广泛用于治疗急性缺血性中风和急性出血性中风。然而,早期使用脑血舒口服液的安全性和有效性数据尚缺乏。本研究的主要目的是观察早期使用脑血舒口服液(脑出血<72小时)的益处和安全性,并为出血性脑卒中患者脑血舒口服液的潜在优越性及其医疗费用提供证据。本次脑血舒口服液防治脑出血的注册研究将是一项定量、前瞻性、多中心、观察性临床注册研究。我们的目标是在发病后 7 天内登记 2000 名脑出血患者。本研究将是一项观察性研究,不会干扰参与者的用药方案。因此,我们不会分配患者。主要观察指标为脑出血后14天(或出院时)血肿量及减少比例、发病12个月内新发脑卒中(缺血性脑卒中、出血性脑卒中)、日常生活活动自理能力(改良Rankin量表评分≤2)、住院期间总费用、治疗费用。本注册研究将为脑血舒口服液预防和治疗脑出血的有效性和安全性提供有力的证据,特别是早期使用(发病后72小时)。它将提供证据证明脑血舒口服液对出血性中风患者的潜在优势,包括医疗费用。
更新日期:2024-02-25
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