Steroid for Treatment of Acute/Subacute Severe Cerebral Venous Thrombosis.

NCT05990894 | Completed FDA Drug

• 1 other identifier: [2020]098
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cerebral Venous Thrombosis

Keywords

Cerebral venous thrombosis; Severe cerebral venous thrombosis; Steroid therapy

Outcome Measures

Primary Outcomes (1)

• favorable functional outcome.

  mRS score ≤2 indicates favorable functional outcome.

  6 months after discharge

Secondary Outcomes (2)

• Serious steroid complications during hospitalization

  from admission to discharge (up to 4 weeks after admission)

• Serious steroids complications within 6 months after discharge

  6 months after discharge

Study Arms (2)

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.

Drug: Methylprednisolone

Interventions

Methylprednisolone DRUG

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.

Steroid therapy group

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, China

Location

Related Publications (1)

• 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.

  PMID: 40033789 DERIVED

MeSH Terms

Conditions

Intracranial Thrombosis

Interventions

Methylprednisolone

Condition Hierarchy (Ancestors)

Intracranial Embolism and Thrombosis; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Thromboembolism; Embolism and Thrombosis

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Jiangang Duan, MD, PhD

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: August 6, 2023
• First Posted: August 14, 2023
• Study Start: July 1, 2020
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)