Risk Factor Analysis and Development of a Predictive Model for Clinical Deterioration During Hospitalization in Patients With Cerebral Venous Thrombosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 273
- Locations
- 1
- Primary Endpoint
- Number of Participants with CVT deteriorated on radiology
Study Overview
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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Number of Participants with CVT deteriorated on radiology
Time Frame: 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
Time Frame: 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
Time Frame: After admission until discharge, a maximum of 30 days
GCS Score decreased
Secondary Outcomes
- Emergency surgery rates(After admission until discharge, a maximum of 30 days)
- Neurological function at 30th day after onset (mRS)(30th day after onset)
Investigators
Wang Shuo
Director of Department of cerebrovascular Neurosurgery
Beijing Tiantan Hospital