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CompletedNCT05487066Updated May 8, 2024

Efficacy of ICU-VTE Scale in ICU Patients

An observational study in Venous Thromboembolism, sponsored by Lijuan Zhang. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-08.

Sponsored by Lijuan Zhang · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
269
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Venous Thromboembolism

Keywords

  • Venous thromboembolism
  • Deep vein thrombosis
  • ICU
  • Critically ill
03

In context

Thromboembolism

818 studies on the registry are indexed under Thromboembolism; 98 are open to participants now.

This study's enrollment of 269 is below the median of 500 across 344 observational studies indexed under Thromboembolism.

Browse Thromboembolism studies →

Lead sponsor

This is the only study on the registry with Lijuan Zhang as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Inpatient in intensive care unit department of Wuhan Central Hospital

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
269 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. incidence of VTE

    inhospital venous thromboembolism occurrence

    Time frame: 28-day

Secondary outcomes

  1. all-cause mortality

    Death from all causes during hospitalization

    Time frame: 28-day

07

Study locations

1 site
  • The Central Hospital of Wuhan
    Wuhan, Hubei 430014, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05487066
Lead sponsor
Lijuan Zhang
Responsible party
Lijuan Zhang (physician, Wuhan Central Hospital) — Sponsor-investigator
First posted
Aug 4, 2022
Start date
May 1, 2022
Primary completion
Dec 10, 2023
Completion
Dec 10, 2023
Last update
May 8, 2024

Study contacts

Juan Li Zhang, Master
principal investigator · Intensive Care Unit, the Central Hospital of Wuhan

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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