Cerebral Venous Thrombosis Cohort Study in China Mainland

Not yet recruiting

• Conditions: Cerebral Venous Sinus Thrombosis; Cortical Vein Thrombosis; Deep Cerebral Vein Thrombosis

• Registration Number: NCT03919305
• Lead Sponsor: Capital Medical University

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.

Study Timeline

• Status Verified: 2019-04
• Study First Submitted: 2019-04-03
• Study First Submitted QC: 2019-04-16
• Last Update Submitted: 2019-04-16
• Study First Posted: 2019-04-18
• Last Update Posted: 2019-04-18
• Study Start: 2019-06-01
• Primary Completion: 2028-05-31
• Study Completion: 2029-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 3000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Incidence of epilepsy	1 year from baseline
Incidence of allergic reaction	1 year from baseline