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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05448248
Other study ID # RETAIN-CH
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 20, 2022
Est. completion date December 20, 2023

Study information

Verified date February 2024
Source Capital Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 3276
Est. completion date December 20, 2023
Est. primary completion date December 20, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design


Locations

Country Name City State
China Xuan Wu Hospital,Capital Medical University Beijing Beijing

Sponsors (5)

Lead Sponsor Collaborator
Capital Medical University Brain Hospital of Hunan Provincial, Guizhou Provincial People's Hospital, The Affiliated Hospital of Xuzhou Medical University, The First Affiliated Hospital of Zhengzhou University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Favorable clinical outcome (modified Rankin score 0-1) Baseline to three years
Primary All-cause mortality A combination of death form of all causes Baseline to three years
Secondary Recurrence of cerebral venous thrombosis Diagnosed by DSA, MRV, CTV or HR-MRI Baseline to three years
Secondary Favorable clinical outcome (modified Rankin score 0-2) Baseline to three years
Secondary Headache after CVT Headache Impact Test - 6 score Baseline to three years
Secondary Incidence of hemorrhagic complication Extracranial hemorrhage (fall in hemoglobin of 2 gram/dl or more within 48 hours) or intracranial hemorrhage Baseline to three years
Secondary Recanalization rate of cerebral venous system Baseline to three years
Secondary Incidence of epilepsy Baseline to three years
Secondary Incidence of acute ischemic stroke Baseline to three years
Secondary Incidence of pulmonary embolism Baseline to three years
Secondary Psychological distress after CVT Population Health Questionnaire (PHQ)-9 score Baseline to three years
See also
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