Cerebral Venous Thrombosis
Conditions
Keywords
cerebral venous thrombosis, direct oral anticoagulants, rivaroxaban, dabigatran, major bleeding, recurrent VTE, modified Rankin Scale, quality of life, prospective cohort, observational study
Brief summary
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.
Detailed description
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.
Interventions
DRUGDabigatran
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.
DRUGRivaroxaban
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.
Sponsors
Hieu Trung Dinh
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed informed consent (ICF) to participate in the study * Age ≥ 18 years * Confirmed diagnosis of cerebral venous thrombosis (CVT) based on clinical presentation and neuroimaging, including one or more of the following: MRI and MRV, AND/OR CT and CTV, AND/OR MRI or CT combined with DSA * Initiation of DOACs within 5 to 15 days after starting treatment with heparin
Exclusion criteria
* CVT accompanied by antiphospholipid syndrome with all three positive laboratory criteria: lupus anticoagulant, anticardiolipin antibodies, and anti-β2-glycoprotein antibodies * CVT in pregnant patients requiring continuous anticoagulation throughout pregnancy * CVT with coexisting bleeding disorders, including immune thrombocytopenia with platelet count \<100,000/mL, hemophilia A or B, von Willebrand disease, or a history of prolonged bleeding after surgery or invasive procedures * CVT in patients with mechanical heart valves, atrial fibrillation, and moderate to severe mitral stenosis * CVT in patients with a glomerular filtration rate (GFR) \<15 mL/min * CVT with severe hepatic impairment * Patients already receiving anticoagulation therapy for another underlying condition at the time of CVT diagnosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite of major bleeding or recurrent venous thromboembolism | Within 6 months after CVT diagnosis | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality Rate | At 6 months after CVT diagnosis | All-cause mortality |
| Functional outcome | At 3 and 6 months after after CVT diagnosis | 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. |
| Number of participants with major bleeding events | At 3 and 6 months after CVT diagnosis | Number of major bleeding events, defined according to the criteria established by the International Society on Thrombosis and Haemostasis (ISTH). |
| Number of participants with clinically relevant non-major bleeding (CRNMB) events | At 3 and 6 months after CVT diagnosis | Number of CRNMB events, defined according to the criteria established by the International Society on Thrombosis and Haemostasis (ISTH) |
| Number of participants who discontinued anticoagulant therapy early | At 6 months after CVT diagnosis | 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. |
| Number of participants with symptomatic recurrent venous thromboembolism (VTE) | At 3 and 6 months after CVT diagnosis | Number of participants who experience symptomatic recurrent venous thromboembolism (VTE), including cerebral venous thrombosis, deep vein thrombosis, pulmonary embolism, or splanchnic thrombosis. |
| Health-related quality of life (EQ-5D-5L utility index score) | At 3 and 6 months after CVT diagnosis | 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. |
| Serial D-dimer measurements after CVT | At 3 and 6 months after CVT diagnosis | 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. |
| Venous recanalization | At 6 months after CVT diagnosis | 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 |
| Frequency of chronic headache after CVT | At 6 months after CVT diagnosis | 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 |
| Number of participants with arterial thrombotic events | At 6 months after CVT diagnosis | 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. |
Countries
Vietnam
Contacts
Primary ContactHieu T. Dinh, MD
Outcome results
None listed