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

Capital Medical University

Status: Completed

Conditions: Cerebral Venous Thrombosis

Treatments: Drug: Methylprednisolone

Study type: Observational

Funder types: Other

Identifiers

NCT05990894

[2020]098

Details and patient eligibility

About

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.

Full 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.

Enrollment: 170 patients

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

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

Trial design

170 participants in 2 patient groups

Standard treatment group

Description:

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

Description:

Patients in the steroid therapy group received short-term steroids in addition to standard anticoagulant therapy.

Treatment:

Drug: Methylprednisolone