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中国颅内静脉血栓形成多中心登记研究(RETAIN-CH):研究目的和设计。

Multicenter registry study of cerebral venous thrombosis in china (RETAIN-CH): Rationale and design.

机构信息

Beijing Institute for Brain Disorders, Capital Medical University, Beijing, China.

The George Institute for Global Health, University of New South Wales, Sydney, Australia.

出版信息

Brain Behav. 2024 Apr;14(4):e3353. doi: 10.1002/brb3.3353.

Abstract

BACKGROUND AND RATIONALE

Cerebral venous thrombosis (CVT) is a rare cerebrovascular disorder that mainly affects young and middle-aged adults. Epidemiological data on the incidence, risk factors, diagnosis, treatment, and prognosis of CVT are lacking in China. In addition, there is a lack of evidence from large, multicenter, real-world studies on the efficacy and safety of endovascular.

AIM

To understand the incidence, diagnosis and treatment status of CVT in China and to estimate the effectiveness and safety of endovascular treatment in the real-world.

METHODS

A multicenter, retrospective observational cohort study will be conducted on CVT patient records from 104 hospitals, between January 1, 2018 and June 30, 2022, identified using a 2-stage cluster sampling design based on per capita gross domestic product. Each enrolled participant is required to complete a further follow-up, which includes the current situation and the assessment at 3 and 12 months after discharge.

STUDY OUTCOMES

The outcomes of this study will include the current status of the incidence, pathogenesis, etiology, clinical symptoms, diagnosis, and treatment of CVT in China, as well as the effectiveness and safety of endovascular treatment in the real-world.

DISCUSSION

Results from this study will provide evidence on the incidence, specific risk factors, symptomatic and imaging features, and clinical outcomes of CVT in China as well as indicate whether endovascular treatment is superior to medical management alone for patients with acute CVT in the real-world.

TRIAL REGISTRATION

http://www.

CLINICALTRIALS

gov.

IDENTIFIER

NCT05448248.

摘要

背景与理由

脑静脉血栓形成(CVT)是一种罕见的脑血管疾病,主要影响中青年人群。中国缺乏关于 CVT 的发病率、危险因素、诊断、治疗和预后的流行病学数据。此外,关于血管内治疗的疗效和安全性的大样本、多中心、真实世界研究证据也不足。

目的

了解中国 CVT 的发病、诊断和治疗现状,并评估血管内治疗在真实世界中的疗效和安全性。

方法

采用两阶段聚类抽样设计,根据人均国内生产总值,对 2018 年 1 月 1 日至 2022 年 6 月 30 日期间 104 家医院的 CVT 患者病历进行多中心、回顾性观察队列研究。每个入组患者都需要完成进一步随访,包括出院后 3 个月和 12 个月的现状和评估。

研究结果

本研究的结果将包括中国 CVT 的发病现状、发病机制、病因、临床症状、诊断和治疗,以及血管内治疗在真实世界中的疗效和安全性。

讨论

本研究的结果将为中国 CVT 的发病率、具体危险因素、症状和影像学特征以及临床结局提供证据,并表明血管内治疗是否优于急性 CVT 患者的单纯药物治疗。

试验注册

http://www.

临床试验

gov.

标识符

NCT05448248。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fa6d/11019244/c1b9aa4f012c/BRB3-14-e3353-g001.jpg

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