Clinical trial NCT05448248: Multicenter Registry Study Of Cerebral Venous Thrombosis In China (RETAIN-CH)
Official title: A Registry Study of Cerebral Venous Sinus Thrombosis in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Vein Thrombosis
Cerebral Venous Sinus Thrombosis
Keywords: Cerebral Venous Sinus Thrombosis
Lead sponsor: Capital Medical University
Sponsor class: OTHER
Collaborators: name: Brain Hospital of Hunan Provincial
name: The First Affiliated Hospital of Zhengzhou University
name: The Affiliated Hospital of Xuzhou Medical University
name: Guizhou Provincial People's Hospital
First posted: 2022-07-07
Enrollment: 3276
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with cerebral venous sinus thrombosis, deep cerebral vein thrombosis and cortical vein thrombosis.

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

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 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.

Eligibility 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.

Primary outcomes:
measure: Favorable clinical outcome (modified Rankin score 0-1)
timeFrame: Baseline to three years
measure: All-cause mortality
timeFrame: Baseline to three years
Secondary outcomes:
measure: Recurrence of cerebral venous thrombosis
timeFrame: Baseline to three years
measure: Favorable clinical outcome (modified Rankin score 0-2)
timeFrame: Baseline to three years
measure: Headache after CVT
timeFrame: Baseline to three years
measure: Incidence of hemorrhagic complication
timeFrame: Baseline to three years
measure: Recanalization rate of cerebral venous system
timeFrame: Baseline to three years
measure: Incidence of epilepsy
timeFrame: Baseline to three years
measure: Incidence of acute ischemic stroke
timeFrame: Baseline to three years
measure: Incidence of pulmonary embolism
timeFrame: Baseline to three years
measure: Psychological distress after CVT
timeFrame: Baseline to three years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuan Wu Hospital，Capital Medical University
state: Beijing
Study officials:
References: