Clinical Deterioration in Cerebral Venous Thrombosis: A Predictive Study

NCT06266585 | Completed

• 1 other identifier: HX-B-2023090
• Study Type: observational
• Target: 273
• Locations: 1 country
• Sites: 1

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

Conditions

Cerebral Venous Thrombosis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Neurological function at 30th day after onset (mRS)

  30th day after onset

• Emergency surgery rates

  After admission until discharge, a maximum of 30 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with cerebral venous thrombosis (CVT)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead
• Beijing Chao Yang Hospital: collaborator
• Beijing Friendship Hospital: collaborator

Study Sites (1)

Capital Medical University Affiliated Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Location

Related Publications (1)

• Feng Y, Mo S, Li X, Jiang P, Wu J, Li J, Liu P, Wang S, Liu Q, Tong X. Development and validation of a score for clinical deterioration in patients with cerebral venous thrombosis. Neurosurg Rev. 2025 Jan 16;48(1):56. doi: 10.1007/s10143-025-03224-7.

  PMID: 39815140 DERIVED

MeSH Terms

Conditions

Intracranial Thrombosis

Condition Hierarchy (Ancestors)

Intracranial Embolism and Thrombosis; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Thromboembolism; Embolism and Thrombosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of cerebrovascular Neurosurgery

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: February 20, 2024
• Study Start: January 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: January 1, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

CN (1)