Cerebral Venous Thrombosis Cohort Study in China Mainland

Cerebral Venous Sinus Thrombosis Clinical Trial

— CCC  

Official title:

Cerebral Venous Thrombosis Cohort Study in China Mainland

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03919305
• Other study ID #: CVT-China
• Status: Not yet recruiting
• Start date: June 1, 2019
• Est. completion date: May 31, 2029

Study information

• Verified date: April 2019
• Source: Capital Medical University
• Contact: Min Li, MD, PhD
• Phone: +86-18701519698
• Email: 812879698[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3000
• Est. completion date: May 31, 2029
• Est. primary completion date: May 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Venous Sinus Thrombosis
• Cortical Vein Thrombosis
• Deep Cerebral Vein Thrombosis
• Sinus Thrombosis, Intracranial
• Thrombosis
• Venous Thrombosis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Capital Medical University	Beijing Municipal Science & Technology Commission

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death rate	A combination of death form of all causes	1 year from baseline
Primary	Functional independence	Defined as modified Rankin score (0-5) equal to or lower than 2	1 year from baseline
Primary	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
Primary	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
Primary	Incidence of sinus wall rupture		1 year from baseline
Primary	Incidence of acute ischemic stroke		1 year from baseline
Primary	Incidence of acute myocardial infarction		1 year from baseline
Primary	Incidence of pulmonary embolism		1 year from baseline
Primary	Incidence of deep venous thrombosis		1 year from baseline
Secondary	Incidence of epilepsy		1 year from baseline
Secondary	Incidence of allergic reaction		1 year from baseline