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Cerebral Venous Thrombosis Cohort Study in China Mainland

  • Clinicaltrials.gov identifier

    NCT03919305

  • Recruitment Status

    Not yet recruiting

  • First Posted

    April 18, 2019

  • Last update posted

    April 18, 2019

Study Description

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.

  • Condition or Disease:Deep Cerebral Vein Thrombosis
    Cortical Vein Thrombosis
    Cerebral Venous Sinus Thrombosis
  • Intervention/Treatment:
  • Phase: N/A

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 Design

  • Study Type: Observational
  • Estimated Enrollment: 3000 participants
  • Observational Model: Cohort
  • Time Perspective: Prospective
  • Official Title: Cerebral Venous Thrombosis Cohort Study in China Mainland
  • Estimated Study Start Date: June 2019
  • Estimated Primary Completion Date: May 2028
  • Estimated Study Completion Date: May 2029

Outcome Measures

  • Primary Outcome Measures: 1. Death rate [ Time Frame: 1 year from baseline ]
    A combination of death form of all causes
  • 2. Functional independence [ Time Frame: 1 year from baseline ]
    Defined as modified Rankin score (0-5) equal to or lower than 2
  • 3. Recurrence of cerebral venous sinus thrombosis, deep cerebral venous thrombosis and cortical vein thrombosis [ Time Frame: 1 year from baseline ]
    Diagnosed by DSA, MRV, CTV or HR-MRI
  • 4. Incidence of hemorrhagic complication [ Time Frame: 1 year from baseline ]
    Extracranial hemorrhage (fall in hemoglobin of 2 gram/dl or more within 48 hours) or intracranial hemorrhage
  • 5. Incidence of sinus wall rupture [ Time Frame: 1 year from baseline ]
  • 6. Incidence of acute ischemic stroke [ Time Frame: 1 year from baseline ]
  • 7. Incidence of acute myocardial infarction [ Time Frame: 1 year from baseline ]
  • 8. Incidence of pulmonary embolism [ Time Frame: 1 year from baseline ]
  • 9. Incidence of deep venous thrombosis [ Time Frame: 1 year from baseline ]
  • Secondary Outcome Measures: 1. Incidence of epilepsy [ Time Frame: 1 year from baseline ]
  • 2. Incidence of allergic reaction [ Time Frame: 1 year from baseline ]
  • Biospecimen Retention: Samples With DNA

    DNA detection will be conducted in a ramdom selection of 300 blood samples.

Eligibility Criteria

  • Ages Eligible for Study: (Child, Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • Sampling Method: Probability Sample
  • Study Population: Patients with cerebral venous sinus thrombosis, deep cerebral vein thrombosis and cortical vein thrombosis.

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.

Contacts and Locations

Contacts

Contact: Min Li, MD, PhD +86-18701519698 812879698@qq.com

Locations

Sponsors and Collaborators

Capital Medical University

Beijing Municipal Science & Technology Commission

Investigators

Principal Investigator: Xunming Ji, MD, PhD Xuanwu Hospital, Beijing

More Information

  • Responsible Party: Capital Medical University
  • ClinicalTrials.gov Identifier: NCT03919305 History of Changes
  • Other Study ID Numbers: CVT-China
  • First Posted: April 18, 2019 Key Record Dates
  • Last Update Posted: April 18, 2019
  • Last Verified: April 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Capital Medical University: Cerebral venous sinus thrombosis
    Deep cerebral vein thrombosis
    Cortical vein thrombosis
    Cohort study
    Real world evidence
    Observational study
    China mainland
    Cerebral venous system thrombosis
  • Additional relevant MeSH terms: Sinus Thrombosis, Intracranial
    Venous Thrombosis
    Thrombosis