Cerebral Venous Thrombosis Cohort Study in China Mainland

Study Overview
=================
Brief Summary
-----------------
This study was aimed to reveal the clinical features,natural history of the diseases and current therapeutic situations of cerebral venous thrombosis (CVT) in China mainland. Blood samples and cerebrospinal fluid samples will be collected after recruitment to reveal the pathological mechanisms of CVT and identify the biomarkers for CVT.

Detailed Description
-----------------
cerebral venous thrombosis (CVT) is caused by a clot in the cerebral vein, which resulted in an obstruction of the blood outflow. CVT mainly includes cerebral venous sinus thrombosis, deep cerebral vein thrombosis and cortical vein thrombosis. However, the epidemiological features of CVT in China mainland remained obscure. This study was aimed to establish a multicenter cohort recruiting patients with CVT across 31 provinces and municipalities in China mainland. Clinical features,natural history of the diseases and current therapeutic situations will be analyzed to reveal the epidemiological features of CVT. Blood samples and cerebrospinal fluid samples will be collected after recruitment to reveal the pathological mechanisms of CVT and identify the biomarkers for CVT. Patients will be followed-up at 1, 3, 6, 12 months from baseline to evaluate the clinical prognosis and therapeutic outcomes.

Official Title
-----------------
Cerebral Venous Thrombosis Cohort Study in China Mainland

Conditions
-----------------
Cerebral Venous Sinus Thrombosis, Deep Cerebral Vein Thrombosis, Cortical Vein Thrombosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Cerebral venous sinus thrombosis, deep cerebral vein thrombosis and cortical vein thrombosis diagnosed by digital subtraction angiography (DSA), magnetic resonance venography (MRV), computed tomography venography (CTV) or high-resolution magnetic resonance imaging (HR-MRI). Exclusion Criteria: • None of the patient, trustee or immediate family members signed the informed consent.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death rate | A combination of death form of all causes | 1 year from baseline | 
| Functional independence | Defined as modified Rankin score (0-5) equal to or lower than 2 | 1 year from baseline | 
| Recurrence of cerebral venous sinus thrombosis, deep cerebral venous thrombosis and cortical vein thrombosis | Diagnosed by DSA, MRV, CTV or HR-MRI | 1 year from baseline | 
| Incidence of hemorrhagic complication | Extracranial hemorrhage (fall in hemoglobin of 2 gram/dl or more within 48 hours) or intracranial hemorrhage | 1 year from baseline | 
| Incidence of sinus wall rupture |  | 1 year from baseline | 
| Incidence of acute ischemic stroke |  | 1 year from baseline | 
| Incidence of acute myocardial infarction |  | 1 year from baseline | 
| Incidence of pulmonary embolism |  | 1 year from baseline | 
| Incidence of deep venous thrombosis |  | 1 year from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of epilepsy |  | 1 year from baseline | 
| Incidence of allergic reaction |  | 1 year from baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cerebral venous sinus thrombosis, Deep cerebral vein thrombosis, Cortical vein thrombosis, Cohort study, Real world evidence, Observational study, China mainland, Cerebral venous system thrombosis