Cerebral Venous Thrombosis Cohort Study in China Mainland (CCC)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cerebral Venous Sinus Thrombosis; Deep Cerebral Vein Thrombosis; Cortical Vein Thrombosis

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 Type: Observational
• Enrollment (Anticipated): 3000

Contacts and Locations

• Study Contact: Name: Min Li, MD, PhD; Phone Number: +86-18701519698; Email: 812879698@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with cerebral venous sinus thrombosis, deep cerebral vein thrombosis and cortical vein thrombosis.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

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	Time Frame
Incidence of epilepsy	1 year from baseline
Incidence of allergic reaction	1 year from baseline

Collaborators and Investigators

• Sponsor: Capital Medical University
• Collaborators: Beijing Municipal Science & Technology Commission
• Investigators: Principal Investigator: Xunming Ji, MD, PhD, Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2019
• Primary Completion (Anticipated): May 31, 2028
• Study Completion (Anticipated): May 31, 2029

Study Registration Dates

• First Submitted: April 3, 2019
• First Submitted That Met QC Criteria: April 16, 2019
• First Posted (Actual): April 18, 2019

Study Record Updates

• Last Update Posted (Actual): April 18, 2019
• Last Update Submitted That Met QC Criteria: April 16, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Cohort study; Observational study; Cerebral venous sinus thrombosis; Deep cerebral vein thrombosis; Cortical vein thrombosis; Real world evidence; China mainland; Cerebral venous system thrombosis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Embolism and Thrombosis; Intracranial Thrombosis; Intracranial Embolism and Thrombosis; Thromboembolism; Thrombosis; Venous Thrombosis; Sinus Thrombosis, Intracranial
• Other Study ID Numbers: CVT-China

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No