Clinical Deterioration in Cerebral Venous Thrombosis: A Predictive Study

Risk Factor Analysis and Development of a Predictive Model for Clinical Deterioration During Hospitalization in Patients With Cerebral Venous Thrombosis

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 Overview

• Status: Completed
• Conditions: Cerebral Venous Thrombosis

• Study Type: Observational
• Enrollment (Actual): 273

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Capital Medical University Affiliated Beijing Tiantan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with cerebral venous thrombosis (CVT)

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with CVT deteriorated on radiology	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.	After admission until discharge, a maximum of 30 days
Number of Participants with altered neurological function	mRS Score decreased due to decreased consciousness, increased focal neurological impairment, new focal neurological impairment or death.	After admission until discharge, a maximum of 30 days
Number of Participants with altered consciousness	GCS Score decreased	After admission until discharge, a maximum of 30 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Collaborators: Beijing Friendship Hospital; Beijing Chao Yang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): January 1, 2024

Study Registration Dates

• First Submitted: January 5, 2024
• First Submitted That Met QC Criteria: February 16, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Disease Attributes; Embolism and Thrombosis; Disease Progression; Thrombosis; Venous Thrombosis; Clinical Deterioration
• Other Study ID Numbers: HX-B-2023090

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No