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ICU Venous Thromboembolism Incidence Study in a Chinese Population

This study is currently recruiting participants.
Verified July 2011 by National Taiwan University Hospital
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01504087
First received: July 19, 2011
Last updated: January 4, 2012
Last verified: July 2011
History of Changes
  Purpose

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
Venous Thromboembolism

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • deep venous thrombosis by ultrasound [ Time Frame: day 14 after ICU admission ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • any clinical thromboembolic event [ Time Frame: day 14 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

blood


Estimated Enrollment: 200
Study Start Date: May 2011
Groups/Cohorts
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01504087

Contacts
Contact: Chi-sheng Hung, MD 886-972-655354 dtmed186@yahoo.com.tw

Locations
Taiwan
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
Investigators
Principal Investigator: Yung-Wei Chen, MD National Taiwan University Hospital Yunlin branch
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01504087     History of Changes
Other Study ID Numbers: 201011022RC
Study First Received: July 19, 2011
Last Updated: January 4, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
patient in critical care

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
 Vascular Diseases
Cardiovascular Diseases
Thrombosis

ClinicalTrials.gov processed this record on June 18, 2013