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Predicting the Risk of Venous Thromboembolism in Critically Ill Patients

NCT05498142 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 7600

Last updated 2022-08-15

No results posted yet for this study

Summary

Introduction: Venous thrombosis (VTE), including both deep vein thrombosis (DVT) and pulmonary embolism (PE) remains a frequent complication in patients admitted to the Intensive Care Unit (ICU). Multiple prediction models for estimating the risk of VTE have been developed. However, many models have not been externally validated. The aim of this study is to perform a comprehensive external validation of pre-existing prediction models for predicting the risk of in-hospital VTE in critically ill patients. In case current risk assessment models fail, the investigators aim to additionally develop and internally validate a new risk prediction model.

Methods: During the first phase of the study the investigators will perform external validation of existing prediction models. The performance, discrimination, calibration and clinical usefulness of the models will be evaluated. In the second phase of the study, in case performance of current risk assessment models is deemed insufficient for clinical application, the investigators will develop a model for predicting the risk of in-hospital VTE in critically ill patients. A multivariable prediction model will be constructed using a combination of predefined candidate predictors. This model will be internally validated and performance will be compared with performance of existing VTE risk prediction models.

Dissemination: This protocol will be published online. This study will be reported according to the Transparent reporting of a multivariable prediction model for individual prognosis or diagnosis (TRIPOD) statement and this study will be submitted to a peer-reviewed journal for publication.

Conditions

  • Venous Thromboembolism
  • Critical Illness

Sponsors & Collaborators

  • University Medical Center Groningen

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2023-08-31
Completion
2023-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05498142 on ClinicalTrials.gov