Cerebral Venous Thrombosis Cohort Study in China Mainland

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03919305

Acronym

CCC

Enrollment

3000

Registered

2019-04-18

Start date

2019-01-01

Completion date

2026-12-31

Last updated

2026-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Venous Sinus Thrombosis, Cortical Vein Thrombosis, Deep Cerebral 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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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 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

Measure	Time frame
Incidence of epilepsy	1 year from baseline
Incidence of allergic reaction	1 year from baseline

Countries

China

Contacts

CONTACTMin Li, MD, PhD

812879698@qq.com+86-18701519698

PRINCIPAL_INVESTIGATORXunming Ji, MD, PhD

Xuanwu Hospital, Beijing

Outcome results