Cerebral Venous Sinus ThrombosisDANANG-CVTNCT07890675
Danang Cerebral Venous Thrombosis Registry
An observational study of Cerebral Venous Sinus Thrombosis and Stroke, run by Da Nang Hospital at 1 site in Vietnam.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Venous Sinus Thrombosis, Stroke, Cerebral Venous Thrombosis
- What is being tested?
- Standard Anticoagulant Therapy
- Type of treatment
- Pill or oral medicine
- How many people
- 110 participants
- Where
- 1 siteVietnam
- Study dates
- 9 Oct 2025to 1 Jul 2029
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Age 18 years or older.
- Definite diagnosis of cerebral venous thrombosis (CVT) confirmed by neuroimaging, including computed tomography venography (CTV), magnetic resonance venography (MRV), or digital subtraction angiography (DSA).
- Admitted to Danang Hospital for acute or subacute management.
- Patient or legally authorized representative provides written informed consent to participate in the registry.
Who cannot join
- Non-thrombotic occlusion of cerebral veins or sinuses (e.g., direct tumor invasion, vascular malformation, or extrinsic mechanical compression without thrombosis).
- Pre-existing advanced terminal illness or severe co-morbid condition with a life expectancy of less than 6 months prior to CVT presentation (e.g., end-stage malignancy, advanced organ failure).
- pre-stroke modified Rankin Scale (mRS) score ≥ 2
- Inability or refusal of the patient or their legal representative to complete the 6-month follow-up assessment.
- Refusal to provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
Da Nang Hospital
Da Nang, Da Nang, 50000
Son V. D. Nguyen, MD, MSc, +84934995168, dangsonnguyen1892@gmail.com
About this study
Official title: A Prospective Registry of Patients With Cerebral Venous Thrombosis at Da Nang Hospital: Clinical Characteristics, Imaging Manifestations, and Functional Outcomes
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 computed tomography (CT), computed tomography venography (CTV), magnetic resonance imaging (MRI), or magnetic resonance venography (MRV), and inpatient complications. Functional outcomes and recovery are evaluated at hospital discharge and during follow-up using the modified Rankin Scale (mRS).
Read the detailed description
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 and coagulation profiles, including prothrombin time (PT), activated partial thromboplastin time (aPTT), fibrinogen, and 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.
- Being tested
- Standard Anticoagulant Therapy
- Keywords
- Cerebral venous sinus thrombosis, CVST, Stroke, Cerebral venous thrombosis, Vietnam, Da Nang, Registry, Danang Hospital, CVT
- Medical subject headings
- Stroke, Intracranial Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Anticoagulant TherapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Cerebral venous thrombosis (CVT) cohort | 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. Receives: Drug: Standard Anticoagulant Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: At 6 months post-diagnosis
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: At 6 months post-diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start9 Oct 2025
- Primary completion9 Oct 2028 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Venous Sinus ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Da Nang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Son V. D. Nguyen, MD, MSc, Principal investigator, Da Nang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07890675
- Sponsor's protocol ID
- 1650/BVDN-HDDD
- Acronym
- DANANG-CVT
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Registry of Patients With Cerebral Venous Thrombosis at Da Nang Hospital: Clinical Characteristics, Imaging Manifestations, and Functional Outcomes
- ClinicalTrials.gov ID
- NCT07890675
- Acronym / sponsor ID
- DANANG-CVT / 1650/BVDN-HDDD
- Keywords
- Cerebral venous sinus thrombosis, CVST, Stroke, Cerebral venous thrombosis, Vietnam, Da Nang, Registry, Danang Hospital
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Da Nang HospitalUniversity, hospital or other
- Study start
- 9 Oct 2025 (actual)
- Primary completion
- 9 Oct 2028 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 22 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 computed tomography (CT), computed tomography venography (CTV), magnetic resonance imaging (MRI), or magnetic resonance venography (MRV), and inpatient complications. Functional outcomes and recovery are evaluated at hospital discharge and during follow-up using the modified Rankin Scale (mRS).
Detailed description
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 and coagulation profiles, including prothrombin time (PT), activated partial thromboplastin time (aPTT), fibrinogen, and 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cerebral venous thrombosis (CVT) cohort | – | Drug: Standard Anticoagulant TherapyAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- Age 18 years or older.
- Definite diagnosis of cerebral venous thrombosis (CVT) confirmed by neuroimaging, including computed tomography venography (CTV), magnetic resonance venography (MRV), or digital subtraction angiography (DSA).
- Admitted to Danang Hospital for acute or subacute management.
- Patient or legally authorized representative provides written informed consent to participate in the registry.
Key exclusion criteria (5 listed)
- Non-thrombotic occlusion of cerebral veins or sinuses (e.g., direct tumor invasion, vascular malformation, or extrinsic mechanical compression without thrombosis).
- Pre-existing advanced terminal illness or severe co-morbid condition with a life expectancy of less than 6 months prior to CVT presentation (e.g., end-stage malignancy, advanced organ failure).
- pre-stroke modified Rankin Scale (mRS) score ≥ 2
- Inability or refusal of the patient or their legal representative to complete the 6-month follow-up assessment.
- Refusal to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Anticoagulant TherapyPatients 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. | Drug | Cerebral venous thrombosis (CVT) cohort |
Primary outcome
Favorable Functional Outcome Assessed by the Modified Rankin Scale (mRS)
Time frame: At 6 months post-diagnosis
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)
3 secondary outcomes
Venous Recanalization Rate at 6 Months
Time frame: At 6 months post-diagnosis
All-Cause Mortality at 6 Months
Time frame: At 6 months post-diagnosis
Health-Related Quality of Life Assessed by the EuroQol 5-Dimension (EQ-5D-5L) Questionnaire
Time frame: At 6 months post-diagnosis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Son V. D. Nguyen, MD, MSc principal investigator
Da Nang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Venous Sinus Thrombosis and Stroke, run by Da Nang Hospital at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Son V. D. Nguyen, MD, MSc (+84 934995168, dangsonnguyen1892@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Favorable Functional Outcome Assessed by the Modified Rankin Scale (mRS) (time frame: At 6 months post-diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.