Cerebral Venous ThrombosisNCT06266585
Clinical Deterioration in Cerebral Venous Thrombosis: A Predictive Study
An observational study of Cerebral Venous Thrombosis, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
The objective of this retrospective, prospective, multicenter cohort study is to determine the risk factors for deterioration of CVT patients after admission and establish a scoring model for risk stratification of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Venous Thrombosis
- How many people
- 273 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 1 Jan 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with cerebral venous thrombosis (CVT)
Who may be able to join
- Age≥ 18 years old
- Patients were diagnosed with cerebral venous thrombosis (CVT) through imaging techniques such as Computed Tomography Venography (CTV), Magnetic Resonance Venography (MRV), or Digital Subtraction Angiography (DSA)
- The diagnostic algorithm for CVT conformed to the current guideline criteria
Who cannot join
- Patients who had performed endovascular treatment (EVT) or decompressive craniectomy (DC) before admission and those whose primary treatment was EVT or DC rather than conservative treatment after admission
- Patients with severe hepatic or renal insufficiency
- Patients with intracranial tumors
- Patients with other cerebrovascular diseases
Trial locations and contacts
1 site in 1 country.
China1 site
Capital Medical University Affiliated Beijing Tiantan Hospital
Beijing, Beijing Municipality
About this study
Official title: Risk Factor Analysis and Development of a Predictive Model for Clinical Deterioration During Hospitalization in Patients With Cerebral Venous Thrombosis
The objective of this retrospective, prospective, multicenter cohort study is to determine the risk factors for deterioration of CVT patients after admission and establish a scoring model for risk stratification of patients. This study included two stages, the first stage was to enroll CVT patients from a single center from 2017 to 2022 for modeling, and the second stage was to enroll CVT patients from three centers in 2023 for external validation
- Conditions
- Cerebral Venous Thrombosis
- Medical subject headings
- Intracranial Thrombosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with CVT deteriorated on radiology
One of the following situations occurs: new or progressive bleeding or infarction, midline displacement (>3mm), increased cerebral edema, and placeholder effect by comparing the CT before and after; mRS and/or GCS decreased due to decreased consciousness, increased focal neurological impairment, new focal neurological impairment or death.
Measured: After admission until discharge, a maximum of 30 days
Number of Participants with altered neurological function
mRS Score decreased due to decreased consciousness, increased focal neurological impairment, new focal neurological impairment or death.
Measured: After admission until discharge, a maximum of 30 days
Number of Participants with altered consciousness
GCS Score decreased
Measured: After admission until discharge, a maximum of 30 days
Secondary outcomes (2)
Neurological function at 30th day after onset (mRS)
MRS was used to evaluate the neurological function of patients at 30th day after onset.
Measured: 30th day after onset
Emergency surgery rates
Rate of patients receiving emergency surgery for severe brain edema or hernia (including endovascular treatment and bone flap decompression).
Measured: After admission until discharge, a maximum of 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start1 Jan 2023
- Primary completion31 Dec 2023
- Study completion1 Jan 2024
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 Venous ThrombosisStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe 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
- 273 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Chao Yang Hospital, Beijing Friendship Hospital
- Responsible party
- Principal investigator, Wang Shuo, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06266585
- Sponsor's protocol ID
- HX-B-2023090
- Status last verified
- Feb 2024
- First submitted
- 5 Jan 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Feng Y, Mo S, Li X, Jiang P, Wu J, Li J, Liu P, Wang S, Liu Q, Tong X. Development and validation of a score for clinical deterioration in patients with cerebral venous thrombosis. Neurosurg Rev. 2025 Jan 16;48(1):56. doi: 10.1007/s10143-025-03224-7.
PubMed 39815140
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factor Analysis and Development of a Predictive Model for Clinical Deterioration During Hospitalization in Patients With Cerebral Venous Thrombosis
- ClinicalTrials.gov ID
- NCT06266585
- Acronym / sponsor ID
- HX-B-2023090
- Conditions
- Cerebral Venous Thrombosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 273 participants (actual)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- Beijing Chao Yang Hospital, Beijing Friendship Hospital
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 20 Feb 2024 (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.
The objective of this retrospective, prospective, multicenter cohort study is to determine the risk factors for deterioration of CVT patients after admission and establish a scoring model for risk stratification of patients. This study included two stages, the first stage was to enroll CVT patients from a single center from 2017 to 2022 for modeling, and the second stage was to enroll CVT patients from three centers in 2023 for external validation
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cerebral venous thrombosis (CVT)
Key inclusion criteria (3 listed)
- Age≥ 18 years old
- Patients were diagnosed with cerebral venous thrombosis (CVT) through imaging techniques such as Computed Tomography Venography (CTV), Magnetic Resonance Venography (MRV), or Digital Subtraction Angiography (DSA)
- The diagnostic algorithm for CVT conformed to the current guideline criteria
Key exclusion criteria (4 listed)
- Patients who had performed endovascular treatment (EVT) or decompressive craniectomy (DC) before admission and those whose primary treatment was EVT or DC rather than conservative treatment after admission
- Patients with severe hepatic or renal insufficiency
- Patients with intracranial tumors
- Patients with other cerebrovascular diseases
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
Number of Participants with CVT deteriorated on radiology
Time frame: After admission until discharge, a maximum of 30 days
One of the following situations occurs: new or progressive bleeding or infarction, midline displacement (>3mm), increased cerebral edema, and placeholder effect by comparing the CT before and after; mRS and/or GCS decreased due to decreased consciousness, increased focal neurological impairment, new focal neurological impairment or death.
Number of Participants with altered neurological function
Time frame: After admission until discharge, a maximum of 30 days
mRS Score decreased due to decreased consciousness, increased focal neurological impairment, new focal neurological impairment or death.
Number of Participants with altered consciousness
Time frame: After admission until discharge, a maximum of 30 days
GCS Score decreased
2 secondary outcomes
Neurological function at 30th day after onset (mRS)
Time frame: 30th day after onset
Emergency surgery rates
Time frame: After admission until discharge, a maximum of 30 days
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 20 Feb 2024.
- Derived from this study: PubMed 39815140Feng Y, Mo S, Li X, Jiang P, Wu J, Li J, Liu P, Wang S, Liu Q, Tong X. Development and validation of a score for clinical deterioration in patients with cerebral venous thrombosis. Neurosurg Rev. 2025 Jan 16;48(1):56. doi: 10.1007/s10143-025-03224-7.
- Individual participant dataSharing planned: Undecided
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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. 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 Venous Thrombosis, run by Beijing Tiantan Hospital 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 3 inclusion and 4 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 20 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?
Number of Participants with CVT deteriorated on radiology (time frame: After admission until discharge, a maximum of 30 days). The study lists 3 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 NCT06266585, 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 20 Feb 2024.