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National Real-world Study of Cerebral Venous Thrombosis in China

Sponsor
Capital Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05448248
Collaborator
Brain Hospital of Hunan Provincial (Other), The First Affiliated Hospital of Zhengzhou University (Other), The Affiliated Hospital of Xuzhou Medical University (Other), Guizhou Provincial People's Hospital (Other)
800
Enrollment
1
Location
12.3
Anticipated Duration (Months)
64.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will investigate the epidemiology, risk factors, diagnostics, treatment, and the long-term prognosis of cerebral venous thrombosis in China.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The epidemiology, risk factors, diagnosis and treatment of Cerebral Venous Thrombosis (CVT) in China are still unclear. A retrospective hospital-based study will be conducted at fifty different hospitals across 31 provinces in China. This study will use ICD-10 to search patients diagnosed with CVT between January 1, 2018 and June 15, 2022 across 31 provinces and municipalities of 50 hospitals in China. Risk factors, clinical and radiological findings, treatment and short-term outcomes will be recorded from the hospital record system. Finally, a prospective follow-up will be conducted for all of the patients enrolled above. By combining data collected from retrospective hospital records with the new follow-up, it will be possible to better understand the epidemiology, risk factors, diagnosis, treatment and the long-term prognosis of CVT in China.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    800 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    A Registry Study of Cerebral Venous Sinus Thrombosis in China
    Anticipated Study Start Date :
    Jul 20, 2022
    Anticipated Primary Completion Date :
    Mar 30, 2023
    Anticipated Study Completion Date :
    Jul 30, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Favorable clinical outcome (modified Rankin score 0-1) [Baseline to three years]

    2. All-cause mortality [Baseline to three years]

      A combination of death form of all causes

    Secondary Outcome Measures

    1. Recurrence of cerebral venous thrombosis [Baseline to three years]

      Diagnosed by DSA, MRV, CTV or HR-MRI

    2. Favorable clinical outcome (modified Rankin score 0-2) [Baseline to three years]

    3. Headache after CVT [Baseline to three years]

      Headache Impact Test - 6 score

    4. Incidence of hemorrhagic complication [Baseline to three years]

      Extracranial hemorrhage (fall in hemoglobin of 2 gram/dl or more within 48 hours) or intracranial hemorrhage

    5. Recanalization rate of cerebral venous system [Baseline to three years]

    6. Incidence of epilepsy [Baseline to three years]

    7. Incidence of acute ischemic stroke [Baseline to three years]

    8. Incidence of pulmonary embolism [Baseline to three years]

    9. Psychological distress after CVT [Baseline to three years]

      Population Health Questionnaire (PHQ)-9 score

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Xuan Wu Hospital，Capital Medical University Beijing Beijing China 100069

    Sponsors and Collaborators

    • Capital Medical University
    • Brain Hospital of Hunan Provincial
    • The First Affiliated Hospital of Zhengzhou University
    • The Affiliated Hospital of Xuzhou Medical University
    • Guizhou Provincial People's Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ji Xunming,MD,PhD, Capital Medical University, Capital Medical University
    ClinicalTrials.gov Identifier:
    NCT05448248
    Other Study ID Numbers:
    • Try- Fast
    First Posted:
    Jul 7, 2022
    Last Update Posted:
    Jul 7, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ji Xunming,MD,PhD, Capital Medical University, Capital Medical University
    Cerebral Venous Sinus Thrombosis
    Additional relevant MeSH terms:
    Sinus Thrombosis, Intracranial
    Thrombosis

    Study Results

    No Results Posted as of Jul 7, 2022