Statistical analysis plan for the Chinese Herbal medicine in Acute INtracerebral haemorrhage (CHAIN) trial.

IF 2.2 3区医学 Q3 CLINICAL NEUROLOGY

Cerebrovascular Diseases Pub Date : 2024-07-23 DOI:10.1159/000540444

Qiang Li, Craig S Anderson, Rustam Al-Shahi Salman, Graeme J Hankey, Laurent Billot, Yang Zhao, Guanghai Tang, Jianwen Guo, Lili Song

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引用次数: 0

Abstract

Introduction: The traditional Chinese medicine (TCM) herbal compound FYTF-919 (Zhong Feng Xing Nao prescription) may improve outcome from acute intracerebral hemorrhage (ICH) by reducing brain edema, hematoma absorption, and enhancement of the immune system. We outline the statistical analysis plan (SAP) for the Chinese Herbal medicine in Acute INtracerebral haemorrhage (CHAIN) study.

Design: CHAIN is a multicenter, prospective, randomized, double-blind, placebo-controlled trial being undertaken at 20-30 hospitals in China. After the completion of eligibility checks, patients are randomly allocated to FYTF-919 (100 mL per day, oral) or matching placebo over 28 days. A sample size of 1504 patients is estimated to provide 90% power (α 0.05) for a 0.06 absolute improvement in the primary outcome of utility-weighted modified Rankin scale scores at 90 days, analyzed by general linear regression.

Methods: The statistical analysis plan was developed by the study statistician, principal investigators, international experts, and the study project manager. The plan provides details for analyzing baseline characteristics, patient management, and outcomes. It includes provisions for covariate adjustments, subgroup analysis, the handling missing data, and in the conduct of sensitivity analyzes.

Results: A predefined statistical analysis plan was established for CHAIN, facilitating transparent and verifiable analysis.

Conclusions: The CHAIN statistical analysis plan was prospectively developed with a focus on maintaining high-quality standards of internal validity to minimise potential analysis biases.

Trial registration: ClinicalTrials.gov (NCT05066620).

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中药治疗急性脑出血（CHAIN）试验的统计分析计划。

简介：中药复方FYTF-919（中风行脑方）可通过减轻脑水肿、血肿吸收和增强免疫系统改善急性脑出血（ICH）的预后。我们概述了中药治疗急性脑出血（CHAIN）研究的统计分析计划（SAP）：CHAIN是一项多中心、前瞻性、随机、双盲、安慰剂对照试验，目前正在中国的20-30家医院进行。在完成资格审查后，患者被随机分配到FYTF-919（每天100毫升，口服）或匹配的安慰剂中，为期28天。根据一般线性回归分析，1504名患者的样本量估计可提供90%的力量（α 0.05），使90天后的主要结果--效用加权改良Rankin量表评分--绝对值提高0.06：统计分析计划由研究统计员、主要研究人员、国际专家和研究项目经理共同制定。该计划提供了分析基线特征、患者管理和结果的详细信息。其中包括协变量调整、亚组分析、缺失数据处理以及敏感性分析的规定：为 CHAIN 制定了预定义的统计分析计划，有助于进行透明、可验证的分析：CHAIN统计分析计划是前瞻性制定的，重点是保持高质量的内部有效性标准，以最大限度地减少潜在的分析偏差：试验注册：ClinicalTrials.gov (NCT05066620)。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Cerebrovascular Diseases 医学-临床神经学

CiteScore

4.50

自引率

0.00%

发文量

审稿时长

1 months

期刊介绍： A rapidly-growing field, stroke and cerebrovascular research is unique in that it involves a variety of specialties such as neurology, internal medicine, surgery, radiology, epidemiology, cardiology, hematology, psychology and rehabilitation. ''Cerebrovascular Diseases'' is an international forum which meets the growing need for sophisticated, up-to-date scientific information on clinical data, diagnostic testing, and therapeutic issues, dealing with all aspects of stroke and cerebrovascular diseases. It contains original contributions, reviews of selected topics and clinical investigative studies, recent meeting reports and work-in-progress as well as discussions on controversial issues. All aspects related to clinical advances are considered, while purely experimental work appears if directly relevant to clinical issues.