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Evaluation of the impact of short-term glucocorticoid pulse therapy on clinical outcome the patients with severe cerebral venous thrombosis: A randomized controlled trial integrating dynamic proteomics analysis

Evaluation of the impact of short-term glucocorticoid pulse therapy on clinical outcome the patients with severe cerebral venous thrombosis: A randomized controlled trial integrating dynamic proteomics analysis

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600124390
Enrollment
Unknown
Registered
2026-05-11
Start date
2026-05-15
Completion date
Unknown
Last updated
2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute/subacute severe cerebral venous thrombosis

Interventions

Standard anticoagulation group:Low molecular weight heparin followed by bridging to warfarin or other oral anticoagulants.
Corticosteroid?adjuvant plus standard anticoagulation group:Methylprednisolone pulse and sequential tapering therapy.

Sponsors

Xuanwu Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. The diagnosis of cerebral venous thrombosis (CVT) is established by an experienced neurologist based on comprehensive assessment of clinical presentation, medical history, physical examination, and ancillary examination results; among which, imaging confirmation must be obtained by conventional magnetic resonance imaging (MRI) or magnetic resonance black-blood thrombus imaging (MRBTI) sequences; 2. Patients with severe CVT (Note: Severity is defined as meeting any one of the following criteria: presence of complications including venous cerebral infarction, intracerebral hemorrhage, subarachnoid hemorrhage, epileptic seizures, or impaired consciousness); 3. Currently in the acute/subacute phase (Note: Acute/subacute phase is defined as time from symptom onset to admission <=15 days, OR time from symptom worsening to admission =15 days, AND imaging shows thrombus signal characteristics consistent with acute/subacute stage on T1/T2-weighted sequences, contrast-enhanced MRI, or MRBTI); 4. Aged 14–80 years; 5. Both sexes; 6. Provide written informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: 1. Age <14 years or foreign patients; 2. Pregnant women or postpartum women within 42 days after delivery; 3. Presence of any severe systemic disease with poor prognosis within 1 year, such as acute cerebral infarction, traumatic brain injury, cancer, unstable angina, uncontrolled asthma, etc; 4. Diagnosis of immune-related diseases (e.g., Behçet's disease, systemic lupus erythematosus, etc.) based on medical history and admission examination results; 5. Active progressive tuberculosis; 6. Patients with severe diseases of the circulatory, respiratory, urinary, digestive, or hematopoietic systems; 7. Absolute contraindications to corticosteroid use, such as uncontrolled infection, severe diabetes mellitus, etc; 8. Pre-onset modified Rankin Scale (mRS) score =3; 9. Cerebral herniation with refusal of decompressive craniectomy, or no recovery of pupillary light reflex after decompressive craniectomy.

Design outcomes

Primary

MeasureTime frame
Proportion of good functional outcome (defined as a modified Rankin Scale [mRS] score of 0–2).;

Secondary

MeasureTime frame
Incidence of adverse events related to corticosteroid use;National Institutes of Health Stroke Scale (NIHSS) score;Recurrence of cerebral venous thrombosis;Dynamic changes in serum and cerebrospinal fluid proteomics;All-cause mortality rate;A modified Rankin Scale (mRS) score;

Countries

China

Contacts

Public ContactDuan Jiangang

Xuanwu Hospital, Capital Medical University

duanjiangang@xwhosp.org+86 10 8319 8302

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 22, 2026