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

Sponsor

Xuanwu Hospital, Beijing (Other)

Overall Status

Completed

CT.gov ID

NCT05990894

Collaborator

(none)

248

Enrollment

Location

Actual Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebral Venous Thrombosis	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 Design

Study Type:

Observational

Actual Enrollment :

248 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2018

Actual Primary Completion Date :

Dec 31, 2021

Actual Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

modified Rankin score(mRS) [6 months after discharge]
mRS score >2 indicates poor prognosis and mRS score ≤2 indicates favorable outcome.

Secondary Outcome Measures

Recurrence of CVT [6 months after discharge]
Diagnosed by MRI/MRBTI/MRV, CTV, or DSA.
Serious steroids complications [6 months after discharge]
Lower extremity deep venous thrombosis. Pulmonary embolism Spontaneous fractures or osteonecrosis Infection gastroduodenal ulcer