Cerebral Vein Thrombosis Clinical Trial
Official title:
A Registry Study of Cerebral Venous Sinus Thrombosis in China
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 |
Verified date | February 2024 |
Source | Capital Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study will investigate the epidemiology, risk factors, diagnostics, treatment, and the long-term prognosis of cerebral venous thrombosis in China.
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. |
Country | Name | City | State |
---|---|---|---|
China | Xuan Wu Hospital,Capital Medical University | Beijing | Beijing |
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 |
China,
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 |
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