Clinical Deterioration in Cerebral Venous Thrombosis: A Predictive Study

Cerebral Venous Thrombosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06266585
• Other study ID #: HX-B-2023090
• Status: Completed
• Start date: January 1, 2023
• Est. completion date: January 1, 2024

Study information

• Verified date: February 2024
• Source: Beijing Tiantan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 273
• Est. completion date: January 1, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Venous Thrombosis
• Clinical Deterioration
• Thrombosis
• Venous Thrombosis

Locations

Country	Name	City	State
China	Capital Medical University Affiliated Beijing Tiantan Hospital	Beijing	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital	Beijing Chao Yang Hospital, Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Number of Participants with altered consciousness	GCS Score decreased	After admission until discharge, a maximum of 30 days
Secondary	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
Secondary	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