NCT05487066

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
269

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 4, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2023

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

1.6 years

First QC Date

July 26, 2022

Last Update Submit

May 7, 2024

Conditions

Keywords

Venous thromboembolismDeep vein thrombosisICUCritically ill

Outcome Measures

Primary Outcomes (1)

  • incidence of VTE

    inhospital venous thromboembolism occurrence

    28-day

Secondary Outcomes (1)

  • all-cause mortality

    28-day

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Inpatient in intensive care unit department of Wuhan Central Hospital

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Central Hospital of Wuhan

Wuhan, Hubei, 430014, China

Location

MeSH Terms

Conditions

Venous ThromboembolismVenous ThrombosisCritical Illness

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesThrombosisDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Juan Li Zhang, Master

    Intensive Care Unit, the Central Hospital of Wuhan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
physician

Study Record Dates

First Submitted

July 26, 2022

First Posted

August 4, 2022

Study Start

May 1, 2022

Primary Completion

December 10, 2023

Study Completion

December 10, 2023

Last Updated

May 8, 2024

Record last verified: 2024-05

Locations