ABSTRACT NUMBER: ESOC2026OT24 STEROID ADJUNCTIVE THERAPY IN ACUTE/ SUBACUTE SEVERE CEREBRAL VENOUS THROMBOSIS (SAVER-CVT): MULTICENTRE RCT PROTOCOL (SAVER-CVT)

Abstract Background and aims Inflammation contributes to severe cerebral venous thrombosis (CVT) pathophysiology and correlates with disease occurrence, severity, and poor prognosis. Cohort data suggest steroid pulse therapy may improve functional outcomes. Methods To determine whether steroids adjunctive therapy improves functional outcomes and is safe in patients with acute/subacute severe CVT. Results This is a multicentre, randomized controlled trial with blinded endpoint assessment. We plan to enroll 310 patients (December 2025–December 2027), randomizing 1:1 to steroid plus anticoagulation or anticoagulation alone. All receive immediate anticoagulation; the intervention group additionally receives a 12–14 day methylprednisolone pulse course (≈2040 mg total) within 2 days post-randomization. Other treatments are unrestricted. The primary outcome is the distribution of 90-day mRS scores. Secondary outcomes include 14-day mRS and NIHSS scores, hormone-related adverse events, and all-cause mortality. An exploratory biomarker sub-study will be conducted in a pre-defined subgroup of patients from both arms, involving serial measurements of intracranial pressure, serum high-sensitivity C-reactive protein (hs-CRP), and interleukin 6 (IL-6) during hospitalisation, with papilloedema (graded by the Frisén scale) assessed at baseline and at the 90-day follow-up. Conclusions The glucocorticoid group is expected to demonstrate a shift towards better (lower) scores on the 90-day mRS, without increased safety events. In the exploratory subgroup, the glucocorticoid group is also anticipated to show greater reductions in intracranial pressure and inflammatory markers during hospitalization, and a greater reduction in Frisén scores from baseline to the 90-day follow-up. Conflict of interest