ICU Venous Thromboembolism Incidence Study in a Chinese Population

Using Inflammatory Markers to Predict the Development and Outcome of Venous Thromboembolism in an Intensive Care Unit

Venous thromboembolism (VTE) is one of the major public health problems in Western country. More than 100,000 Americans die each year from VTE. VTE is also a common complication of critical illness,1-2 and probably related to poor outcome in this patient group. Although there are guidelines about VTE prophylaxis in acutely ill medical patients and patients in medical ICU3, they are overlooked in our daily practice frequently in our country. There are many reasons for our common practice, including inadequate knowledge for the ICU physicians, more patients with bleeding tendency in ICU and low prevalence of VTE in our (eastern) country. However, the true prevalence of VTE in ICU and if thromboprophylaxis still needed in certain high risk patients are not unknown. Besides, if there is a difference in the VTE rate between western and eastern patients, what is the underlying mechanism? The major objective of this application is to answer the first part of the problem, i.e. to delineate the scope of this problem.

The specific aims of this application are as follows:

• prevalence of venous thromboembolism in ICU in Taiwan
• specific risk in subgroups of ICU patients
• prevalence and risk factors for silent pulmonary embolism

Study Overview

• Status: Unknown
• Conditions: Venous Thromboembolism

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Taiwan
  • Douliu, Taiwan, 640
    • Recruiting
    • National Taiwan University Hospital Yunlin Branch
    • Contact: Chi-sheng Hung, MD
    • Principal Investigator: Yung-Wei Chen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients admitted to ICU with age over 18 y/o are eligible

Description

Inclusion Criteria:

• All patients admitted to medical ICU with age over 18 y/o are eligible

Exclusion Criteria:

• Patients who do not sign the informed consent will be excluded from this study

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
patinet with deep venous thrombosis; patient with deep venous thrombosis by ultrasonography as case; patient with no deep venous thrombosis by ultrasonography as control
patient without deep venous thrombosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
deep venous thrombosis by ultrasound	day 14 after ICU admission

Secondary Outcome Measures

Outcome Measure	Time Frame
any clinical thromboembolic event	day 14

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Yung-Wei Chen, MD, National Taiwan University Hospital Yunlin Branch

Study record dates

Study Major Dates

• Study Start: May 1, 2011

Study Registration Dates

• First Submitted: July 19, 2011
• First Submitted That Met QC Criteria: January 4, 2012
• First Posted (ESTIMATE): January 5, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): January 5, 2012
• Last Update Submitted That Met QC Criteria: January 4, 2012
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: patient in critical care
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thromboembolism; Venous Thromboembolism
• Other Study ID Numbers: 201011022RC