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| Name | Class |
|---|---|
| Beijing Municipal Science & Technology Commission | OTHER |
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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.
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.
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| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of epilepsy | 1 year from baseline | |
| Incidence of allergic reaction | 1 year from baseline |
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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.
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Patients with cerebral venous sinus thrombosis, deep cerebral vein thrombosis and cortical vein thrombosis.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Min Li, MD, PhD | Contact | +86-18701519698 | 812879698@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Xunming Ji, MD, PhD | Xuanwu Hospital, Beijing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital, Capital Medical University | Recruiting | Beijing | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 16, 2019 | Apr 16, 2019 | SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 16, 2019 | Apr 16, 2019 | ICF_001.pdf |
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DNA detection will be conducted in a ramdom selection of 300 blood samples.