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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cerebral Venous Thrombosis

Intervention / Treatment
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* Drug: Methylprednisolone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute (within 7 days after symptom onset) or subacute (8-15 days since symptom onset) severe CVT diagnosed by MRI+MRV, CT+CTV, or DSA. Exclusion Criteria: Patients with malignancies Patients with incomplete follow-up data.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Standard treatment group<br>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<br>Patients in the steroid therapy group received short-term steroids in addition to standard anticoagulant therapy. | Drug: Methylprednisolone<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| modified Rankin score(mRS) | mRS score >2 indicates poor prognosis and mRS score ≤2 indicates favorable outcome. | 6 months after discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of CVT | Diagnosed by MRI/MRBTI/MRV, CTV, or DSA. | 6 months after discharge | 
| Serious steroids complications | Lower extremity deep venous thrombosis. Pulmonary embolism Spontaneous fractures or osteonecrosis Infection gastroduodenal ulcer | 6 months after discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cerebral venous thrombosis, Severe cerebral venous thrombosis, Steroid therapy