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ICU Venous Thromboembolism Incidence Study in a Chinese Population

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01504087
Recruitment Status : Unknown
Verified July 2011 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : January 5, 2012
Last Update Posted : January 5, 2012
Information provided by (Responsible Party):
National Taiwan University Hospital

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

Condition or disease
Venous Thromboembolism

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Using Inflammatory Markers to Predict the Development and Outcome of Venous Thromboembolism in an Intensive Care Unit
Study Start Date : May 2011

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. deep venous thrombosis by ultrasound [ Time Frame: day 14 after ICU admission ]

Secondary Outcome Measures :
  1. any clinical thromboembolic event [ Time Frame: day 14 ]

Biospecimen Retention:   Samples Without DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients admitted to ICU with age over 18 y/o are eligible

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01504087

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Contact: Chi-sheng Hung, MD 886-972-655354

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National Taiwan University Hospital Yunlin branch Recruiting
Douliu, Taiwan, 640
Contact: Chi-sheng Hung, MD         
Principal Investigator: Yung-Wei Chen, MD         
Sponsors and Collaborators
National Taiwan University Hospital
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Principal Investigator: Yung-Wei Chen, MD National Taiwan University Hospital Yunlin Branch
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Responsible Party: National Taiwan University Hospital Identifier: NCT01504087    
Other Study ID Numbers: 201011022RC
First Posted: January 5, 2012    Key Record Dates
Last Update Posted: January 5, 2012
Last Verified: July 2011
Keywords provided by National Taiwan University Hospital:
patient in critical care
Additional relevant MeSH terms:
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Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases