Clinical Deterioration in Cerebral Venous Thrombosis: A Predictive Study

Completed

• Conditions: Cerebral Venous Thrombosis

• Registration Number: NCT06266585
• Lead Sponsor: Beijing Tiantan Hospital

Brief Summary

The objective of this retrospective, prospective, multicenter cohort study is to determine the risk factors for deterioration of CVT patients after admission and establish a scoring model for risk stratification of patients. This study included two stages, the first stage was to enroll CVT patients from a single center from 2017 to 2022 for modeling, and the second stage was to enroll CVT patients from three centers in 2023 for external validation

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Primary Completion: 2023-12-31
• Study Completion: 2024-01-01
• Study First Submitted: 2024-01-05
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-16
• Last Update Submitted: 2024-02-16
• Study First Posted: 2024-02-20
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 273

Inclusion Criteria

• Age≥ 18 years old
• Patients were diagnosed with cerebral venous thrombosis (CVT) through imaging techniques such as Computed Tomography Venography (CTV), Magnetic Resonance Venography (MRV), or Digital Subtraction Angiography (DSA)
• The diagnostic algorithm for CVT conformed to the current guideline criteria

Exclusion Criteria

• Patients who had performed endovascular treatment (EVT) or decompressive craniectomy (DC) before admission and those whose primary treatment was EVT or DC rather than conservative treatment after admission
• Patients with severe hepatic or renal insufficiency
• Patients with intracranial tumors
• Patients with other cerebrovascular diseases

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants with CVT deteriorated on radiology	After admission until discharge, a maximum of 30 days	One of the following situations occurs: new or progressive bleeding or infarction, midline displacement (\>3mm), increased cerebral edema, and placeholder effect by comparing the CT before and after; mRS and/or GCS decreased due to decreased consciousness, increased focal neurological impairment, new focal neurological impairment or death.
Number of Participants with altered neurological function	After admission until discharge, a maximum of 30 days	mRS Score decreased due to decreased consciousness, increased focal neurological impairment, new focal neurological impairment or death.
Number of Participants with altered consciousness	After admission until discharge, a maximum of 30 days	GCS Score decreased

Secondary Outcome Measures

Name	Time	Method
Emergency surgery rates	After admission until discharge, a maximum of 30 days	Rate of patients receiving emergency surgery for severe brain edema or hernia (including endovascular treatment and bone flap decompression).
Neurological function at 30th day after onset (mRS)	30th day after onset	MRS was used to evaluate the neurological function of patients at 30th day after onset.

Trial Locations

Locations (1)

Capital Medical University Affiliated Beijing Tiantan Hospital; 🇨🇳 Beijing, Beijing, China