Clinical trial NCT03919305: Cerebral Venous Thrombosis Cohort Study in China Mainland
Official title: Cerebral Venous Thrombosis Cohort Study in China Mainland
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cerebral Venous Sinus Thrombosis
Deep Cerebral Vein Thrombosis
Cortical Vein Thrombosis
Keywords: Cerebral venous sinus thrombosis
Deep cerebral vein thrombosis
Cortical vein thrombosis
Cohort study
Real world evidence
Observational study
China mainland
Cerebral venous system thrombosis
Lead sponsor: Capital Medical University
Sponsor class: OTHER
Collaborators: name: Beijing Municipal Science & Technology Commission
First posted: 2019-04-18
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with cerebral venous sinus thrombosis, deep cerebral vein thrombosis and cortical vein thrombosis.

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.

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.

Primary outcomes:
measure: Death rate
timeFrame: 1 year from baseline
measure: Functional independence
timeFrame: 1 year from baseline
measure: Recurrence of cerebral venous sinus thrombosis, deep cerebral venous thrombosis and cortical vein thrombosis
timeFrame: 1 year from baseline
measure: Incidence of hemorrhagic complication
timeFrame: 1 year from baseline
measure: Incidence of sinus wall rupture
timeFrame: 1 year from baseline
measure: Incidence of acute ischemic stroke
timeFrame: 1 year from baseline
measure: Incidence of acute myocardial infarction
timeFrame: 1 year from baseline
measure: Incidence of pulmonary embolism
timeFrame: 1 year from baseline
measure: Incidence of deep venous thrombosis
timeFrame: 1 year from baseline
Secondary outcomes:
measure: Incidence of epilepsy
timeFrame: 1 year from baseline
measure: Incidence of allergic reaction
timeFrame: 1 year from baseline
Other outcomes:
Locations:
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Xunming Ji, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: