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Completed

NCT Number: NCT05990894

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.

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Key information

Age range

14 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Xuanwu Hospital, Capital Medical University

Beijing, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. favorable functional outcome.

    Time frame: 6 months after discharge

    mRS score ≤2 indicates favorable functional outcome.

Secondary outcomes

  1. Serious steroid complications during hospitalization

    Time frame: from admission to discharge (up to 4 weeks after admission)

    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
  2. Serious steroids complications within 6 months after discharge

    Time frame: 6 months after discharge

    new-onset of the following conditions:

    • Deep vein thrombosis
    • pulmonary embolism
    • gastric or duodenal ulcers
    • spontaneous fractures, osteonecrosis
    • recurrent CVT

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Aug 14, 2023
Registry last updated
Jul 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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