An observational study in Cerebral Venous Sinus Thrombosis, Stroke and Cerebral Venous Thrombosis, sponsored by Da Nang Hospital. Recruiting at 1 site in Vietnam. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Da Nang Hospital · Observational
Cerebral venous thrombosis (CVT) is an uncommon but potentially life-threatening type of stroke, predominantly affecting young adults and women. Although prompt diagnosis and anticoagulant therapy can lead to favorable outcomes, data regarding the clinical spectrum, neuroimaging patterns, risk factors, and long-term functional recovery of CVT patients in central Vietnam remain limited.
This prospective observational study aims to establish a hospital-based registry to investigate the clinical characteristics, neuroimaging features, etiology, and treatment outcomes of patients diagnosed with cerebral venous thrombosis at Danang Hospital.
All consecutive patients with confirmed CVT admitted to Danang Hospital are enrolled and managed according to standard clinical protocols. Participants are monitored throughout their hospital stay to assess acute manifestations, imaging abnormalities (on CT/CTV or MRI/MRV), and inpatient complications. Functional outcomes and recovery are evaluated at hospital discharge and during follow-up using the modified Rankin Scale (mRS).
This is a single-center, prospective observational cohort registry conducted at Danang Hospital to comprehensively evaluate adult patients with cerebral venous thrombosis (CVT).
Upon admission, all patients with suspected CVT undergo confirmed diagnostic neuroimaging via computed tomography venography (CTV) or magnetic resonance venography (MRV). Standardized case report forms are utilized to collect baseline demographics, predisposing risk factors (such as oral contraceptive use, puerperium, thrombophilia, autoimmune markers, and local head/neck infections), and clinical presentation (headache, seizures, focal neurological deficits, and altered consciousness).
Baseline laboratory evaluations include complete blood counts, coagulation profiles (PT, aPTT, fibrinogen, D-dimer), biochemical panels, and specialized hypercoagulable workups when indicated (protein C, protein S, antithrombin III, antiphospholipid antibodies, and autoimmune serologies). Neuroimaging characteristics are systematically recorded, identifying the involved sinuses/veins (superior sagittal sinus, transverse sinus, sigmoid sinus, straight sinus, internal jugular vein, or cortical veins) and associated parenchymal lesions, including venous infarction, cerebral hemorrhage, and subarachnoid hemorrhage.
Inpatient management follows current clinical practice guidelines, primarily utilizing therapeutic anticoagulation (low-molecular-weight heparin or unfractionated heparin, transitioned to oral anticoagulants) and endovascular interventions when clinically indicated. In-hospital complications, length of stay, and functional status at discharge are documented. Following discharge, patients are scheduled for clinical and neuroimaging follow-up to evaluate functional recovery via the modified Rankin Scale (mRS), venous recanalization rates, and bleeding or thrombotic recurrences.
7,441 studies on the registry are indexed under Stroke; 2,012 are open to participants now.
This study's planned enrollment of 110 is below the median of 160 across 1,729 observational studies indexed under Stroke.
Browse Stroke studies →Da Nang Hospital is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All consecutive adult patients (aged 18 years or older) diagnosed with cerebral venous thrombosis (CVT) admitted to the Stroke and Neurointensive Care Department at Danang Hospital. The diagnosis of CVT must be objectively confirmed by definitive neuroimaging, including magnetic resonance venography (MRV), computed tomography venography (CTV), or digital subtraction angiography (DSA). Patients are enrolled irrespective of clinical presentation (acute, subacute, or chronic onset) and are managed according to standard clinical protocols.
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Exclusion Criteria:
All consecutive adult patients diagnosed with cerebral venous thrombosis (confirmed by CTV or MRV) admitted to Danang Hospital and followed up for clinical characteristics, neuroimaging features, and functional outcomes.
Drug: Standard Anticoagulant Therapy
Patients receive therapeutic anticoagulation according to standard clinical guidelines (low-molecular-weight heparin or unfractionated heparin in the acute phase, followed by oral anticoagulants including vitamin K antagonists or direct oral anticoagulants), along with supportive medical care and endovascular treatment when indicated.
Favorable Functional Outcome Assessed by the Modified Rankin Scale (mRS)
Functional status is evaluated using the modified Rankin Scale (mRS), a standardized clinical tool measuring the degree of disability or dependence in daily activities. The scale ranges from 0 (no symptoms) to 6 (death). A favorable functional outcome is defined as an mRS score of 0 to 1 (complete recovery or no significant disability despite symptoms)
Time frame: At 6 months post-diagnosis
Venous Recanalization Rate at 6 Months
Venous recanalization status of the occluded cerebral venous sinuses and veins will be assessed by follow-up magnetic resonance venography (MRV) or computed tomography venography (CTV) at 6 months. Recanalization is categorized into complete recanalization, partial recanalization, or no recanalization.
Time frame: At 6 months post-diagnosis
All-Cause Mortality at 6 Months
The proportion of patient deaths from any cause occurring within 6 months following diagnosis.
Time frame: At 6 months post-diagnosis
Health-Related Quality of Life Assessed by the EuroQol 5-Dimension (EQ-5D-5L) Questionnaire
Quality of life is evaluated using the EQ-5D-5L questionnaire, which assesses 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 or 5 response levels. In addition, the EQ Visual Analogue Scale (EQ-VAS) records the patient's self-rated health on a vertical visual analogue scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.
Time frame: At 6 months post-diagnosis
Plan to share: No — Individual participant data will not be made publicly available due to patient confidentiality and institutional data governance policies. However, de-identified data may be considered for sharing with qualified researchers upon reasonable scientific request to the corresponding author, subject to formal approval by the Institutional Review Board of Danang Hospital.
No publications or documents are linked to this record.
Started Oct 2025 (actual). Primary completion is estimated for Oct 2028, 36 months after the start.
Of 787 non-industry observational studies under Stroke, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 101. This study's planned 36 months is below that.
Counting every sponsor, half of 833 studies reached it within 41 months; a quarter within 18 and three quarters within 92.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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