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

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Venous Thrombosis
• Intervention / Treatment: Drug: Methylprednisolone

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 Type: Observational
• Enrollment (Actual): 170

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Xuanwu Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
favorable functional outcome.	mRS score ≤2 indicates favorable functional outcome.	6 months after discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	6 months after discharge

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Residual symptoms	Including headaches, visual disturbances, epilepsy, and current work status.	6 months after discharge

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing
• Investigators: Principal Investigator: Jiangang Duan, MD, PhD, Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): July 31, 2024
• Study Completion (Actual): July 31, 2024

Study Registration Dates

• First Submitted: August 6, 2023
• First Submitted That Met QC Criteria: August 6, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): July 11, 2025
• Last Update Submitted That Met QC Criteria: July 9, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Steroid therapy; Cerebral venous thrombosis; Severe cerebral venous thrombosis
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis; Antineoplastic Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protective Agents; Neuroprotective Agents; Methylprednisolone Acetate; Prednisolone; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
• Other Study ID Numbers: [2020]098

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No