Cerebral Vein ThrombosisNCT05448248
Multicenter Registry Study Of Cerebral Venous Thrombosis In China (RETAIN-CH)
An observational study of Cerebral Vein Thrombosis and Cerebral Venous Sinus Thrombosis, run by Capital Medical University at 1 site in China.
Trial summary
This study will investigate the epidemiology, risk factors, diagnostics, treatment, and the long-term prognosis of cerebral venous thrombosis in China. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cerebral Vein Thrombosis, Cerebral Venous Sinus Thrombosis
- How many people
- 3,276 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2022to 20 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with cerebral venous sinus thrombosis, deep cerebral vein thrombosis and cortical vein thrombosis.
Who may be able to join
- 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).
Who cannot join
- None of the patient, trustee or immediate family members signed the informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site
Xuan Wu Hospital，Capital Medical University
Beijing, Beijing Municipality, 100069
About this study
Official title: A Registry Study of Cerebral Venous Sinus Thrombosis in China
This study will investigate the epidemiology, risk factors, diagnostics, treatment, and the long-term prognosis of cerebral venous thrombosis in China.
Read the detailed description
The epidemiology, risk factors, diagnosis and treatment of Cerebral Venous Thrombosis (CVT) in China are still unclear. A retrospective hospital-based study will be conducted at fifty different hospitals across 31 provinces in China. This study will use ICD-10 to search patients diagnosed with CVT between January 1, 2018 and June 15, 2022 across 31 provinces and municipalities of 104 hospitals in China. Risk factors, clinical and radiological findings, treatment and short-term outcomes will be recorded from the hospital record system. Finally, a prospective follow-up will be conducted for all of the patients enrolled above. By combining data collected from retrospective hospital records with the new follow-up, it will be possible to better understand the epidemiology, risk factors, diagnosis, treatment and the long-term prognosis of CVT in China.
- Keywords
- Cerebral Venous Sinus Thrombosis
- Medical subject headings
- Intracranial Thrombosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Favorable clinical outcome (modified Rankin score 0-1)
Measured: Baseline to three years
All-cause mortality
A combination of death form of all causes
Measured: Baseline to three years
Secondary outcomes (9)
Recurrence of cerebral venous thrombosis
Diagnosed by DSA, MRV, CTV or HR-MRI
Measured: Baseline to three years
Favorable clinical outcome (modified Rankin score 0-2)
Measured: Baseline to three years
Headache after CVT
Headache Impact Test - 6 score
Measured: Baseline to three years
Incidence of hemorrhagic complication
Extracranial hemorrhage (fall in hemoglobin of 2 gram/dl or more within 48 hours) or intracranial hemorrhage
Measured: Baseline to three years
Recanalization rate of cerebral venous system
Measured: Baseline to three years
Incidence of epilepsy
Measured: Baseline to three years
Incidence of acute ischemic stroke
Measured: Baseline to three years
Incidence of pulmonary embolism
Measured: Baseline to three years
Psychological distress after CVT
Population Health Questionnaire (PHQ)-9 score
Measured: Baseline to three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start20 Aug 2022
- Primary completion20 Dec 2023
- Study completion20 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral Vein ThrombosisStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 3,276 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Brain Hospital of Hunan Provincial, The First Affiliated Hospital of Zhengzhou University, The Affiliated Hospital of Xuzhou Medical University, Guizhou Provincial People's Hospital
- Responsible party
- Principal investigator, Ji Xunming,MD,PhD, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05448248
- Sponsor's protocol ID
- RETAIN-CH
- Status last verified
- Feb 2024
- First submitted
- 2 Jul 2022
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bian H, Wang X, Liu L, Yan F, Lu S, Hui W, Zhou C, Duan J, Li M, Chen J, Meng R, Cao L, Wang L, Ji X. Multicenter registry study of cerebral venous thrombosis in china (RETAIN-CH): Rationale and design. Brain Behav. 2024 Apr;14(4):e3353. doi: 10.1002/brb3.3353.
PubMed 38622893
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Registry Study of Cerebral Venous Sinus Thrombosis in China
- ClinicalTrials.gov ID
- NCT05448248
- Acronym / sponsor ID
- RETAIN-CH
- Keywords
- Cerebral Venous Sinus Thrombosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,276 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Collaborators
- Brain Hospital of Hunan Provincial, The First Affiliated Hospital of Zhengzhou University, The Affiliated Hospital of Xuzhou Medical University, Guizhou Provincial People's Hospital
- Study start
- 20 Aug 2022 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 7 Jul 2022 (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.
This study will investigate the epidemiology, risk factors, diagnostics, treatment, and the long-term prognosis of cerebral venous thrombosis in China.
Detailed description
The epidemiology, risk factors, diagnosis and treatment of Cerebral Venous Thrombosis (CVT) in China are still unclear. A retrospective hospital-based study will be conducted at fifty different hospitals across 31 provinces in China. This study will use ICD-10 to search patients diagnosed with CVT between January 1, 2018 and June 15, 2022 across 31 provinces and municipalities of 104 hospitals in China. Risk factors, clinical and radiological findings, treatment and short-term outcomes will be recorded from the hospital record system. Finally, a prospective follow-up will be conducted for all of the patients enrolled above. By combining data collected from retrospective hospital records with the new follow-up, it will be possible to better understand the epidemiology, risk factors, diagnosis, treatment and the long-term prognosis of CVT in China.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with cerebral venous sinus thrombosis, deep cerebral vein thrombosis and cortical vein thrombosis.
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- None of the patient, trustee or immediate family members signed the 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.
Primary outcome
Favorable clinical outcome (modified Rankin score 0-1)
Time frame: Baseline to three years
All-cause mortality
Time frame: Baseline to three years
A combination of death form of all causes
9 secondary outcomes
Recurrence of cerebral venous thrombosis
Time frame: Baseline to three years
Favorable clinical outcome (modified Rankin score 0-2)
Time frame: Baseline to three years
Headache after CVT
Time frame: Baseline to three years
Incidence of hemorrhagic complication
Time frame: Baseline to three years
Recanalization rate of cerebral venous system
Time frame: Baseline to three years
Incidence of epilepsy
Time frame: Baseline to three years
Incidence of acute ischemic stroke
Time frame: Baseline to three years
Incidence of pulmonary embolism
Time frame: Baseline to three years
Psychological distress after CVT
Time frame: Baseline to three years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Derived from this study: PubMed 38622893Bian H, Wang X, Liu L, Yan F, Lu S, Hui W, Zhou C, Duan J, Li M, Chen J, Meng R, Cao L, Wang L, Ji X. Multicenter registry study of cerebral venous thrombosis in china (RETAIN-CH): Rationale and design. Brain Behav. 2024 Apr;14(4):e3353. doi: 10.1002/brb3.3353.
Related trials for Cerebral Vein Thrombosis
RecruitingObservational study
Danang Cerebral Venous Thrombosis Registry
Cerebral Venous Sinus Thrombosis, Stroke
Not yet recruitingObservational study
TOF-MRV Versus Post-Contrast 3D T1 MRI in Dural Venous Sinus Thrombosis
Cerebral Thrombosis, Venous Thrombosis
Recruiting
MENA Regional Endovascular Intervention for Venous Cerebral Venous Sinus Thrombosis
Cerebral Venous Sinus Thrombosis
RecruitingPhase 3
Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation for Whom Oral Anticoagulation is Unsuitable
Atrial Fibrillation (AF)
RecruitingObservational study
Treatment Outcomes of Direct Oral Anticoagulants in Cerebral Venous Thrombosis in Vietnam
Cerebral Venous Thrombosis
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Vein Thrombosis and Cerebral Venous Sinus Thrombosis, run by Capital Medical University at 1 site in China.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 26 Feb 2024. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Favorable clinical outcome (modified Rankin score 0-1) (time frame: Baseline to three years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05448248, which also lists 1 linked publication.
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 Feb 2024.