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

Completed

• Conditions: Cerebral Venous Thrombosis
• Interventions: Drug: Methylprednisolone

• Registration Number: NCT05990894
• Lead Sponsor: Xuanwu Hospital, Beijing

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.

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 Timeline

• Study Start: 2020-07-01
• Study First Submitted: 2023-08-06
• Study First Submitted QC: 2023-08-06
• Study First Posted: 2023-08-14
• Primary Completion: 2024-07-31
• Study Completion: 2024-07-31
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-17
• Last Update Posted: 2024-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Steroid therapy group	Methylprednisolone	Patients in the steroid therapy group received short-term steroids in addition to standard anticoagulant therapy.

Primary Outcome Measures

Name	Time	Method
favorable functional outcome.	6 months after discharge	mRS score ≤2 indicates favorable functional outcome.

Secondary Outcome Measures

Name	Time	Method
Serious steroid complications during hospitalization	from admission to discharge (up to 4 weeks after admission)	new-onset of the following conditions: * lower extremity deep vein thrombosis; * pulmonary embolism; * gastric or duodenal ulcers; * spontaneous fractures, osteonecrosis; * infections or worsening of existing infections
Serious steroids complications within 6 months after discharge	6 months after discharge	new-onset of the following conditions: * Deep vein thrombosis; * pulmonary embolism; * gastric or duodenal ulcers; * spontaneous fractures, osteonecrosis; * recurrent CVT

Trial Locations

Locations (1)

Xuanwu Hospital, Capital Medical University; 🇨🇳 Beijing, China