Protocol of a Multicenter Cohort Observational Study of Cerebral Venous Thrombosis in China Mainland

Abstract

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.