Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.
Beijing Institute for Brain Disorders, Capital Medical University, Beijing, China.
Cerebrovasc Dis. 2023;52(2):130-136. doi: 10.1159/000526028. Epub 2022 Aug 18.
Epidemiological data on cerebral venous thrombosis in China are still lacking at present on the aspects of incidence, recurrence, risk factors, and so on. Herein, we aimed to fill the gap, based on the result of this multicenter prospective cohort study. A total of 26 top tertiary hospitals distributed in China Mainland will take part in this study. For the first time, a dataset of cerebral venous thrombosis cohort (including multiethnic patients of all ages in almost all regions of Mainland China, regardless of gender) will be built. Inclusion criteria were as follows: (1) aged ≥14 years, (2) neuroimaging-confirmed cerebral venous thrombosis, (3) symptom onset was within 30 days prior to enrollment, (4) signed the informed consent form. Demographic data, risk factors, clinical and neuroimaging features, ophthalmologic and aural results, blood tests, cerebrospinal fluid examination, therapeutic strategies, and adverse events were analyzed. Two milliliters of fasting venous blood and 2 mL of cerebrospinal fluid will be collected and stored. Furthermore, patients will be followed up at months 1, 3, 6, and 12 after baseline assessment. Primary outcome will be all-cause mortality. Secondary outcomes: (1) cerebrospinal fluid pressure and Frisen grade; (2) recanalization rate on imaging; (3) rating scales such as GCS, NIHSS, mRS, Mini-Mental State Examination, Montreal Cognitive Assessment, Patient Health Questionnaire 9-item, HIT-6, and Tinnitus Handicap Index. This study will for the first time provide strong evidence on the incidence rate, recurrence rate, and demographic data, as well as special risk factors, clinical outcomes, symptomatic and imaging features of cerebral venous thrombosis in Chinese population. The results of this study will also provide an important reference on prevention, early diagnosis, and customized treatment of cerebral venous thrombosis in Chinese patients.
目前，中国关于脑静脉血栓形成的流行病学数据在发病率、复发率、危险因素等方面仍存在不足。在此，我们旨在基于这项多中心前瞻性队列研究的结果填补这一空白。中国大陆的 26 家顶级三甲医院将参与这项研究。这将首次建立一个脑静脉血栓形成队列数据集（包括中国大陆几乎所有地区、所有年龄段的多民族患者，无论性别）。纳入标准如下：（1）年龄≥14 岁；（2）神经影像学证实的脑静脉血栓形成；（3）症状发作在入组前 30 天内；（4）签署知情同意书。分析人口统计学数据、危险因素、临床和神经影像学特征、眼科和耳部结果、血液检查、脑脊液检查、治疗策略和不良事件。将采集并储存 2 毫升空腹静脉血和 2 毫升脑脊液。此外，患者将在基线评估后 1、3、6 和 12 个月进行随访。主要结局为全因死亡率。次要结局：（1）脑脊液压力和 Frisen 分级；（2）影像学再通率；（3）GCS、NIHSS、mRS、简易精神状态检查、蒙特利尔认知评估、患者健康问卷 9 项、HIT-6 和耳鸣残疾指数等评分量表。这项研究将首次为中国人群脑静脉血栓形成的发病率、复发率和人口统计学数据，以及特殊危险因素、临床结局、症状和影像学特征提供有力证据。该研究结果还将为中国患者脑静脉血栓形成的预防、早期诊断和个体化治疗提供重要参考。
