This prospective, single-arm observational cohort study aims to evaluate the real-world effectiveness and safety of direct oral anticoagulants (DOACs), specifically dabigatran or rivaroxaban, in patients with cerebral venous thrombosis (CVT). The study will be conducted at Bach Mai Hospital, a national tertiary stroke referral center in Hanoi, Vietnam. A minimum of 69 adults with radiologically confirmed CVT will be enrolled between June 2025 and June 2027. All participants must have received therapeutic-dose heparin during the acute phase and will be transitioned to a DOAC within 5 to 15 days, per physician judgment. All treatments are part of routine care; no investigational drugs are used. The primary outcome is a composite of major bleeding (per ISTH criteria) or recurrent venous thromboembolism (VTE) within 6 months. Secondary outcomes include: functional outcome (Modified Rankin Scale), venous sinus recanalization, all-cause mortality, serial D-dimer levels, post-CVT chronic headache, health-related quality of life (EQ-5D-5L), clinically relevant non-major bleeding (CRNMB), symptomatic recurrent VTE, arterial thrombotic events, and early treatment discontinuation. This study aims to generate real-world data supporting DOAC use in CVT, particularly in Asian populations where prospective evidence is limited.
Cerebral venous thrombosis (CVT) is an uncommon yet potentially life-threatening cerebrovascular condition. Direct oral anticoagulants (DOACs) are increasingly adopted for CVT management, supported by recent trials (e.g., RESPECT-CVT, CHOICE-CVT, SECRET) and observational cohorts. However, prospective real-world data, especially in low- and middle-income countries like Vietnam, remain scarce. This single-center, prospective, single-arm observational study aims to assess the safety and effectiveness of DOACs (dabigatran or rivaroxaban) in routine clinical practice among CVT patients at Bach Mai Hospital-a leading tertiary referral center in northern Vietnam. Eligible participants are adults (≥18 years) with radiologically confirmed CVT who received therapeutic-dose heparin during the acute phase and are transitioned to a DOAC between days 5 and 15. Patients will be followed for 6 months, with scheduled evaluations of: Clinical outcomes D-dimer levels Neuroimaging for venous sinus recanalization Functional status (Modified Rankin Scale) Health-related quality of life (EQ-5D-5L) Safety outcomes including major bleeding, CRNMB, symptomatic recurrent VTE, arterial events, and chronic headache Early treatment discontinuation and its causes (e.g., adverse events, patient decision) Findings from this study will contribute important real-world evidence to guide clinical practice, especially in Asian populations underrepresented in existing prospective research.
Study Type
OBSERVATIONAL
Enrollment
69
Dabigatran will be initiated between 5 and 15 days after therapeutic-dose heparin in patients with cerebral venous thrombosis (CVT), based on clinical judgment. It is administered as part of routine clinical care.
Rivaroxaban will be initiated between 5 and 15 days after therapeutic-dose heparin in patients with cerebral venous thrombosis (CVT), based on clinical judgment. It is administered as part of routine clinical care.
Bach Mai Hospital
Hanoi, Vietnam
RECRUITINGComposite of major bleeding or recurrent venous thromboembolism
A composite endpoint including: (1) the occurrence of VTE, defined as recurrent CVT, deep vein thrombosis of any limb, pulmonary embolism, or thrombosis involving the splanchnic, jugular, caval, renal, or catheter-related veins; and (2) major bleeding events, defined according to the criteria established by the International Society on Thrombosis and Haemostasis (ISTH)
Time frame: Within 6 months after CVT diagnosis
Mortality Rate
All-cause mortality
Time frame: At 6 months after CVT diagnosis
Functional outcome
Proportion of patients with good functional outcome, defined as a score of 0-1 on the Modified Rankin Scale (mRS). The Modified Rankin Scale ranges from 0 to 6, where 0 indicates no symptoms and 6 indicates death. Lower scores reflect better functional recovery.
Time frame: At 3 and 6 months after after CVT diagnosis
Number of participants with major bleeding events
Number of major bleeding events, defined according to the criteria established by the International Society on Thrombosis and Haemostasis (ISTH).
Time frame: At 3 and 6 months after CVT diagnosis
Number of participants with clinically relevant non-major bleeding (CRNMB) events
Number of CRNMB events, defined according to the criteria established by the International Society on Thrombosis and Haemostasis (ISTH)
Time frame: At 3 and 6 months after CVT diagnosis
Number of participants with symptomatic recurrent venous thromboembolism (VTE)
Number of participants who experience symptomatic recurrent venous thromboembolism (VTE), including cerebral venous thrombosis, deep vein thrombosis, pulmonary embolism, or splanchnic thrombosis.
Time frame: At 3 and 6 months after CVT diagnosis
Number of participants who discontinued anticoagulant therapy early
Number of participants who discontinued DOAC therapy before the duration recommended by their treating physician, and documented reasons for discontinuation (e.g., adverse events, patient decision, or clinical judgment). Reasons will be collected from clinical records and follow-up interviews.
Time frame: At 6 months after CVT diagnosis
Number of participants with arterial thrombotic events
Number of participants who experience arterial thrombotic events, including ischemic stroke, myocardial infarction, or other objectively confirmed arterial thromboses. Events will be confirmed by clinical assessment and/or imaging as appropriate.
Time frame: At 6 months after CVT diagnosis
Health-related quality of life (EQ-5D-5L utility index score)
Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) instrument. This tool evaluates five domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with five levels of severity. A utility index score will be calculated using the Vietnamese EQ-5D-5L value set, ranging from -0.511 to 1.000, where: 1.000 indicates perfect health, 0.000 corresponds to death, scores below 0 indicate health states considered worse than death by the general Vietnamese population.
Time frame: At 3 and 6 months after CVT diagnosis
Serial D-dimer measurements after CVT
Plasma D-dimer levels will be measured at 3 and 6 months using a standardized quantitative assay. Values will be reported in ng/mL and interpreted in the context of post-CVT coagulation activity.
Time frame: At 3 and 6 months after CVT diagnosis
Venous recanalization
Degree of venous sinus recanalization assessed on follow-up neuroimaging (MRI/MRV or CT/CTV) at 6 months. Recanalization will be categorized as complete, partial, or absent, based on standardized radiological criteria
Time frame: At 6 months after CVT diagnosis
Frequency of chronic headache after CVT
Presence and frequency of persistent or recurrent headache fulfilling the International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria for chronic post-CVT headache. Assessment will be based on patient-reported symptoms and clinical evaluation
Time frame: At 6 months after CVT diagnosis
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