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Completed

NCT Number: NCT06266585

Clinical Deterioration in Cerebral Venous Thrombosis: A Predictive Study

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Capital Medical University Affiliated Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. Number of Participants with altered consciousness

    Time frame: After admission until discharge, a maximum of 30 days

    GCS Score decreased

Secondary outcomes

  1. Neurological function at 30th day after onset (mRS)

    Time frame: 30th day after onset

    MRS was used to evaluate the neurological function of patients at 30th day after onset.

  2. Emergency surgery rates

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Collaborators

  • Beijing Chao Yang Hospital
  • Beijing Friendship Hospital

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Feb 20, 2024
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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