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

Cerebral Venous Thrombosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05990894
• Other study ID #: [2020]098
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: August 2023
• Source: Xuanwu Hospital, Beijing
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 248
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Acute (within 7 days after symptom onset) or subacute (8-15 days since symptom onset) severe CVT diagnosed by MRI+MRV, CT+CTV, or DSA.

Exclusion Criteria:

• Patients with malignancies

• Patients with incomplete follow-up data.

Related Conditions & MeSH terms

• Cerebral Venous Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

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.

Locations

Country	Name	City	State
China	Xuanwu Hospital, Capital Medical University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Residual symptoms	Including headaches, visual disturbances, epilepsy, and current work status.	6 months after discharge
Primary	modified Rankin score(mRS)	mRS score >2 indicates poor prognosis and mRS score =2 indicates favorable outcome.	6 months after discharge
Secondary	Recurrence of CVT	Diagnosed by MRI/MRBTI/MRV, CTV, or DSA.	6 months after discharge
Secondary	Serious steroids complications	Lower extremity deep venous thrombosis.; Pulmonary embolism; Spontaneous fractures or osteonecrosis; Infection; gastroduodenal ulcer	6 months after discharge