ICU Venous Thromboembolism Incidence Study in a Chinese Population

NCT01504087 | Unknown

• 1 other identifier: 201011022RC
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Venous Thromboembolism

Keywords

patient in critical care

Outcome Measures

Primary Outcomes (1)

• deep venous thrombosis by ultrasound

  day 14 after ICU admission

Secondary Outcomes (1)

• any clinical thromboembolic event

  day 14

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital Yunlin branch

Douliu, Taiwan, 640, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood

MeSH Terms

Conditions

Venous Thromboembolism

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yung-Wei Chen, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chi-sheng Hung, MD

CONTACT

886-972-655354; dtmed186@yahoo.com.tw

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2011
• First Posted: January 5, 2012
• Study Start: May 1, 2011
• Last Updated: January 5, 2012

Record last verified: 2011-07

Locations

TW (1)