Cerebral Venous ThrombosisNCT05990894
Steroid for Treatment of Acute/Subacute Severe Cerebral Venous Thrombosis.
An observational study of Cerebral Venous Thrombosis, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
The cohort study aims to evaluate the efficacy and safety of steroids combined with anticoagulant therapy compared to standard anticoagulant therapy in acute/subacute severe cerebral venous thrombosis. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Cerebral Venous Thrombosis
- What is being tested?
- Methylprednisolone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 170 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2020to 31 Jul 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult patients with acute/subacute severe CVT were enrolled in a prospective cohort at Xuanwu Hospital, Capital Medical University, between July 2020 and January 2024.
Who may be able to join
- Acute or subacute severe CVT, determined by the onset-to-admission time (≤ 15 days) or symptom aggravation-to-admission time (≤ 15 days) and MRI+MRV/MRBTI (MR Black-Blood Thrombus Imaging), or CT+CTV
Who cannot join
- younger than 14 years；
- foreign nationality；
- receiving steroids before the onset of CVT；
- patients with other serious diseases；
- Presenting with neurological deficits before the onset of CVT；
- lack of baseline data before treatment；
- receiving steroids during hospitalization for other reasons but the dosage did not reach pulsed-therapy level
- brain herniation but refusing to undergo decompressive craniectomy, or pupillary light reflex did not recover after decompressive craniectomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Steroid for Treatment of Acute/Subacute Severe Cerebral Venous Thrombosis.
The cohort study aims to evaluate the efficacy and safety of steroids combined with anticoagulant therapy compared to standard anticoagulant therapy in acute/subacute severe cerebral venous thrombosis.
Read the detailed description
Background: Evidence suggests that the inflammatory response plays a crucial role in regulating severe CVT pathogenesis. However, whether CVT patients can benefit from anti-inflammatory therapy has been debated.
Objective: The objective of this cohort study is to explore the efficacy and safety of steroids combined with anticoagulant therapy compared to standard anticoagulant therapy in acute/subacute severe cerebral venous thrombosis (CVT) patients.
Method: We reviewed the data of patients with acute/subacute severe CVT treated with a short-term application of steroid or not from a prospective stroke registry of our center. We compared functional outcomes and major adverse events at 6 months follow-up after discharge.
- Conditions
- Cerebral Venous Thrombosis
- Being tested
- Methylprednisolone
- Keywords
- Cerebral venous thrombosis, Severe cerebral venous thrombosis, Steroid therapy
- Medical subject headings
- Intracranial Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In the steroid therapy group, patients received standard treatment plus steroid therapy. Steroid therapy protocol is as follows: 500 mg methylprednisolone once a day, intravenous drip for 3 days, then reduced to 80 mg once a day, intravenous drip for 5 days, and changed to oral methylprednisolone/prednisone 1 mg per kilogram body weight, gradually tapered off by a dose of 10 mg per week.
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment group | Each patient received subcutaneous low-molecular-weight heparin in adjusted doses for 10 to 14 days, followed by oral anticoagulants (warfarin or dabigatran or rivaroxaban, if warfarin was used, PT-INR was maintained between 2.0 and 3.0) for 6 months or more. The use of endovascular treatment (local thrombectomy/thrombolysis) was reserved for patients who are still progressing with adequate anticoagulant therapy. | |
| Steroid therapy group | Patients in the steroid therapy group received short-term steroids in addition to standard anticoagulant therapy. Receives: Drug: Methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
favorable functional outcome.
mRS score ≤2 indicates favorable functional outcome.
Measured: 6 months after discharge
Secondary outcomes (2)
Serious steroid complications during hospitalization
new-onset of the following conditions:
- lower extremity deep vein thrombosis
- pulmonary embolism
- gastric or duodenal ulcers
- spontaneous fractures, osteonecrosis
- infections or worsening of existing infections
Measured: from admission to discharge (up to 4 weeks after admission)
Serious steroids complications within 6 months after discharge
new-onset of the following conditions:
- Deep vein thrombosis
- pulmonary embolism
- gastric or duodenal ulcers
- spontaneous fractures, osteonecrosis
- recurrent CVT
Measured: 6 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Jul 2020
- Primary completion31 Jul 2024
- Study completion31 Jul 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 Xuanwu Hospital, BeijingThe 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
- Prospective
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JiangangDuan, Xuanwu Hospital, Beijing
- Investigators
- Jiangang Duan, MD, PhD, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05990894
- Sponsor's protocol ID
- [2020]098
- Status last verified
- Jul 2025
- First submitted
- 6 Aug 2023
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hu S, Gu Y, Zhao T, Zhang K, Li J, Zhou C, Song H, Liu Z, Ji X, Duan J. Steroids combined with anticoagulant in acute/subacute severe cerebral venous thrombosis. Chin Med J (Engl). 2025 Aug 5;138(15):1825-1834. doi: 10.1097/CM9.0000000000003502. Epub 2025 Mar 4.
PubMed 40033789
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Steroid for Treatment of Acute/Subacute Severe Cerebral Venous Thrombosis.
- ClinicalTrials.gov ID
- NCT05990894
- Acronym / sponsor ID
- [2020]098
- Conditions
- Cerebral Venous Thrombosis
- Keywords
- Cerebral venous thrombosis, Severe cerebral venous thrombosis, Steroid therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 14 Aug 2023 (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 cohort study aims to evaluate the efficacy and safety of steroids combined with anticoagulant therapy compared to standard anticoagulant therapy in acute/subacute severe cerebral venous thrombosis.
Detailed description
Background: Evidence suggests that the inflammatory response plays a crucial role in regulating severe CVT pathogenesis. However, whether CVT patients can benefit from anti-inflammatory therapy has been debated.
Objective: The objective of this cohort study is to explore the efficacy and safety of steroids combined with anticoagulant therapy compared to standard anticoagulant therapy in acute/subacute severe cerebral venous thrombosis (CVT) patients.
Method: We reviewed the data of patients with acute/subacute severe CVT treated with a short-term application of steroid or not from a prospective stroke registry of our center. We compared functional outcomes and major adverse events at 6 months follow-up after discharge.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard treatment group | – | –Each patient received subcutaneous low-molecular-weight heparin in adjusted doses for 10 to 14 days, followed by oral anticoagulants (warfarin or dabigatran or rivaroxaban, if warfarin was used, PT-INR was maintained between 2.0 and 3.0) for 6 months or more. The use of endovascular treatment (local thrombectomy/thrombolysis) was reserved for patients who are still progressing with adequate anticoagulant therapy. |
| Steroid therapy group | – | Drug: MethylprednisolonePatients in the steroid therapy group received short-term steroids in addition to standard anticoagulant therapy. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult patients with acute/subacute severe CVT were enrolled in a prospective cohort at Xuanwu Hospital, Capital Medical University, between July 2020 and January 2024.
Key inclusion criteria (1 listed)
- Acute or subacute severe CVT, determined by the onset-to-admission time (≤ 15 days) or symptom aggravation-to-admission time (≤ 15 days) and MRI+MRV/MRBTI (MR Black-Blood Thrombus Imaging), or CT+CTV
Key exclusion criteria (8 listed)
- younger than 14 years；
- foreign nationality；
- receiving steroids before the onset of CVT；
- patients with other serious diseases；
- Presenting with neurological deficits before the onset of CVT；
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 |
|---|---|---|
| MethylprednisoloneIn the steroid therapy group, patients received standard treatment plus steroid therapy. Steroid therapy protocol is as follows: 500 mg methylprednisolone once a day, intravenous drip for 3 days, then reduced to 80 mg once a day, intravenous drip for 5 days, and changed to oral methylprednisolone/prednisone 1 mg per kilogram body weight, gradually tapered off by a dose of 10 mg per week. | Drug | Steroid therapy group |
Primary outcome
favorable functional outcome.
Time frame: 6 months after discharge
mRS score ≤2 indicates favorable functional outcome.
2 secondary outcomes
Serious steroid complications during hospitalization
Time frame: from admission to discharge (up to 4 weeks after admission)
Serious steroids complications within 6 months after discharge
Time frame: 6 months after discharge
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 11 Jul 2025.
- Derived from this study: PubMed 40033789Hu S, Gu Y, Zhao T, Zhang K, Li J, Zhou C, Song H, Liu Z, Ji X, Duan J. Steroids combined with anticoagulant in acute/subacute severe cerebral venous thrombosis. Chin Med J (Engl). 2025 Aug 5;138(15):1825-1834. doi: 10.1097/CM9.0000000000003502. Epub 2025 Mar 4.
- Individual participant dataSharing planned: No
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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.
Jiangang Duan, MD, PhD principal investigator
Xuanwu Hospital, Beijing
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 Xuanwu Hospital, Beijing 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 8 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 11 Jul 2025. 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 functional outcome. (time frame: 6 months after discharge). 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 NCT05990894, 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 11 Jul 2025.