Efficacy of ICU-VTE Scale in ICU Patients

May 7, 2024 updated by: Lijuan Zhang

Efficacy of ICU-VTE Scale in Predicting Venous Thromboembolism in ICU Patients

Venous thromboembolism (VTE) is a common cause of morbidity and mortality among critically ill patients. No uniform standard model of VTE risk for critically ill patients was formatted by now. In 2020, Viarasilpa et al. developed the ICU⁃VTE rating table, mainly for ICU patients. However, it lacks validation. We examined and compared how well the ICU-VTE score predict and stratify VTE risk in comprehensive ICU patients.

Study Overview

Status

Completed

Detailed Description

Venous thromboembolism (VTE) is a group of thromboembolic diseases including deep vein thrombosis (DVT) and pulmonary thromboembolism (PE), which is a systemic disease caused by a combination of risk factors. The risk of venous thromboembolism can be greatly reduced by the preventive treatment of it in hospitalized patients according to their risk level. The common risk assessment tools for inpatient VTE include the Padua score for medical patients and the Caprini score for surgical patients, but there is no clinical basis for implementing risk assessment for critically ill patients. The question of how to perform VTE risk assessment in ICU patients to prevent and treat the occurrence of VTE is worth exploring.

This study was designed according to a prospective study method. Data and information were collected from the time the patients were admitted to the ICU to the time the patients were discharged from the ICU.There are three purposes for this study. First, to observe the predictive effect and evaluate the value of the ICU-VTE scoring scale in comprehensive ICU patients; Second, to compare the advantages and disadvantages of the ICU-VTE scoring tool with the Padua score (internal medicine) and Caprini score tool (surgery); To analyze the risk factors for VTE in comprehensive ICU patients and to optimize the VTE risk prediction model; Third, to look into the prevention and treatment of VTE in critically ill ICU patients.

Study Type

Observational

Enrollment (Actual)

269

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Hubei
      • Wuhan, Hubei, China, 430014
        • The Central Hospital of Wuhan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Inpatient in intensive care unit department of Wuhan Central Hospital

Description

Inclusion Criteria:

  • patients age greater than or equal to 18 years;
  • Patients or their family members agreed to the study and signed informed consent.

Exclusion Criteria:

  • Patients admitted to ICU with VTE diagnosis or diagnosed with VTE within 24 hours of admission to ICU;
  • Use the therapeutic dose of anticoagulation before admission to ICU or within 24 hours in ICU;
  • Expected ICU stay of less than 48 hours;
  • Patients cannot obtain imaging data to confirm the presence of VTE during ICU admission

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of VTE
Time Frame: 28-day
inhospital venous thromboembolism occurrence
28-day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
all-cause mortality
Time Frame: 28-day
Death from all causes during hospitalization
28-day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Juan Li Zhang, Master, Intensive Care Unit, the Central Hospital of Wuhan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Actual)

December 10, 2023

Study Completion (Actual)

December 10, 2023

Study Registration Dates

First Submitted

July 26, 2022

First Submitted That Met QC Criteria

August 2, 2022

First Posted (Actual)

August 4, 2022

Study Record Updates

Last Update Posted (Actual)

May 8, 2024

Last Update Submitted That Met QC Criteria

May 7, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Venous Thromboembolism

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