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ICU Venous Thromboembolism Incidence Study in a Chinese Population

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ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Tracking Information
First Submitted Date July 19, 2011
First Posted Date January 5, 2012
Last Update Posted Date January 5, 2012
Study Start Date May 2011
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: January 4, 2012)
deep venous thrombosis by ultrasound [ Time Frame: day 14 after ICU admission ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: January 4, 2012)
any clinical thromboembolic event [ Time Frame: day 14 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title ICU Venous Thromboembolism Incidence Study in a Chinese Population
Official Title Using Inflammatory Markers to Predict the Development and Outcome of Venous Thromboembolism in an Intensive Care Unit
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
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
blood
Sampling Method Non-Probability Sample
Study Population All patients admitted to ICU with age over 18 y/o are eligible
Condition Venous Thromboembolism
Intervention Not Provided
Study 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: January 4, 2012)
200
Original Estimated Enrollment Same as current
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT01504087
Other Study ID Numbers 201011022RC
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Taiwan University Hospital
Study Sponsor National Taiwan University Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Yung-Wei Chen, MD National Taiwan University Hospital Yunlin Branch
PRS Account National Taiwan University Hospital
Verification Date July 2011