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

Xuanwu Hospital, Beijing170 enrolled

Overview

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.

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

170

Conditions

Cerebral Venous Thrombosis

Interventions

MethylprednisoloneDRUG

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.

Eligibility

Sex: ALLMin age: 14 Years

Medical Language ↔ Plain English

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

Locations (1)

Xuanwu Hospital, Capital Medical University

Beijing, China

Outcomes

Primary Outcomes

favorable functional outcome.

mRS score ≤2 indicates favorable functional outcome.

Time frame: 6 months after discharge

Secondary Outcomes

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

Time frame: 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

Time frame: 6 months after discharge

Data from ClinicalTrials.gov

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