ICU Venous Thromboembolism Incidence Study in a Chinese Population

Venous Thromboembolism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01504087
• Other study ID #: 201011022RC
• Status: Recruiting
• Phase: N/A
• First received: July 19, 2011
• Last updated: January 4, 2012
• Start date: May 2011

Study information

• Verified date: July 2011
• Source: National Taiwan University Hospital
• Contact: Chi-sheng Hung, MD
• Phone: 886-972-655354
• Email: dtmed186[@]yahoo.com.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital Yunlin branch	Douliu

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	deep venous thrombosis by ultrasound		day 14 after ICU admission	No
Secondary	any clinical thromboembolic event		day 14	No