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Completed

NCT Number: NCT05448248

Multicenter Registry Study Of Cerebral Venous Thrombosis In China (RETAIN-CH)

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

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Key information

Conditions

Cerebral Vein Thrombosis Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Venous Sinus Thrombosis Cerebrovascular Disorders Embolism and Thrombosis Intracranial Embolism and Thrombosis Intracranial Thrombosis Nervous System Diseases Thromboembolism Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Xuan Wu Hospital，Capital Medical University

Beijing, Beijing Municipality, 100069, China

About this study

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 104 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Favorable clinical outcome (modified Rankin score 0-1)

    Time frame: Baseline to three years

  2. All-cause mortality

    Time frame: Baseline to three years

    A combination of death form of all causes

Secondary outcomes

  1. Recurrence of cerebral venous thrombosis

    Time frame: Baseline to three years

    Diagnosed by DSA, MRV, CTV or HR-MRI

  2. Favorable clinical outcome (modified Rankin score 0-2)

    Time frame: Baseline to three years

  3. Headache after CVT

    Time frame: Baseline to three years

    Headache Impact Test - 6 score

  4. Incidence of hemorrhagic complication

    Time frame: 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

    Time frame: Baseline to three years

  6. Incidence of epilepsy

    Time frame: Baseline to three years

  7. Incidence of acute ischemic stroke

    Time frame: Baseline to three years

  8. Incidence of pulmonary embolism

    Time frame: Baseline to three years

  9. Psychological distress after CVT

    Time frame: Baseline to three years

    Population Health Questionnaire (PHQ)-9 score

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Collaborators

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

Registry information

Official study title

A Registry Study of Cerebral Venous Sinus Thrombosis in China

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 7, 2022
Registry last updated
Feb 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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