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STA®-Liatest®D-Di-Exclusion of Venous Thromboembolism (DiET)

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.
ClinicalTrials.gov Identifier: NCT01221805
Recruitment Status : Completed
First Posted : October 15, 2010
Last Update Posted : August 5, 2016
University Hospital, Grenoble
Information provided by (Responsible Party):
Diagnostica Stago

Brief Summary:
The purpose of this study is to demonstrate the ability of STA® Liatest® D-Di combined with a clinical pretest probability (PTP) to safely exclude pulmonary embolism (PE) or Deep Venous Thrombosis (DVT) in a 3 month follow-up.

Condition or disease
Deep Venous Thrombosis Pulmonary Embolism D-dimer

Detailed Description:

The study population will be selected from prospective, consecutive ambulatory outpatients suspected of having venous thromboembolism.

These patients will first be evaluated using the Wells score:

  • patients with low or moderate pretest probability will be considered for D-dimer testing, those with D-dimer positive will be considered for an imaging procedure,
  • patients with high pretest probability will be considered for an imaging procedure.

Patients with "low or moderate" pretest probability and a negative D-Dimer result will be followed for 3 months to evaluate potential development of deep venous thrombosis and/or pulmonary embolism.

These patients will be contacted by phone 3 month after their first visit.

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Study Type : Observational
Actual Enrollment : 2040 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: STA®-Liatest®D-Di-Exclusion of Venous Thromboembolism
Study Start Date : November 2011
Actual Primary Completion Date : March 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. To demonstrate the ability of STA Liatest DDi combined with a clinical pretest probability (PTP) to safely exclude pulmonary embolism or deep venous thrombosis in a 3 month follow-up [ Time Frame: at 3 months ]
    Occurence of pulmonary embolism or deep venous thrombosis during the 3 month follow-up after negative diagnosis (i.e. patients with PTP low/moderate and negative STA Liatest D-Di test)

Secondary Outcome Measures :
  1. 1. To analyse results homogeneity (inter-centers) in the group "positive D-dimer result and negative diagnosis" (descriptive statistics only). 2. To determine prevalence of VTE in PTP high patients based on imaging results [ Time Frame: at 3 months ]
    1. Prevalence of VTE in PTP high patients based on imaging results.

Biospecimen Retention:   Samples Without DNA
plasma samples (at least 1 aliquot 0.5 ml) will be collected at the initial visit of patients with low or moderate PTP

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will be recruited from prospective, consecutive, ambulatory outpatients (presenting at the emergency unit or outpatient clinic) suspected of having venous thromboembolism


  1. Patient is < 80 years old.
  2. Patient presenting at least one of these symptoms indicative of proximal DVT or PE:

    • symptoms for proximal DVT: leg pain, tenderness (discomfort through palpation), leg swelling, and /or edema,
    • symptoms for PE: hemoptysis, lung related chest pain, dyspnea.
  3. Patient provides written informed consent to participate in the study (or verbal no-opposition, as allowed by local regulations)
  4. Patient is willing to comply with specified follow-up evaluation at 3 months and can be contacted by telephone


  1. Patient presenting with a condition that may be associated with increased D-dimer levels, even in the absence of VTE, such as:

    • Fibrinolytic therapy within the previous seven (7) days,
    • Bone fracture or surgery (with general anesthesia longer than thirty (30) minutes) within the previous one (1) month,
    • Deep hematoma diagnosed by imaging techniques within the previous one (1) month,
    • Disseminated malignancies and active cancer (active cancer defined as: cancer for which therapeutic or palliative treatment is either ongoing at the time of enrolment or has stopped less than six (6) months before enrolment),
    • Sepsis, severe infections, pneumonia within the previous 1 month,
    • Known liver cirrhosis,
    • Pregnancy or post-partum within the previous 1 month,
    • Atherosclerotic vascular disease thrombosis within the previous 1month (e.g. myocardial infarction, stroke, coronary syndrome, peripheral artery disease stage III or IV),
    • Sickle cell disease,
  2. Patients presenting with a suspect thrombotic event related to catheter implantation
  3. Ongoing therapeutic anticoagulants (curative and preventive treatment) starting twenty four (24) hours or more before the D-dimer is measured
  4. Previous anticoagulant therapy stopped less than three (3) months before the D-dimer is measured
  5. Patients with previous DVT/PE occurred less than three (3) months from screening.
  6. Suspect thrombotic events in other locations at screening, including distal to the knee and upper extremity DVT (based on standard of care examinations)
  7. Patients with known tissue plasminogen activator (tPA) deficiency
  8. Patient participating or who has participated within one month of enrollment in another investigational study
  9. Major co-morbid condition(s) or other reasons that could limit the patient's ability to participate in the study or to comply with follow-up requirements, or impact the scientific integrity of the 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 ClinicalTrials.gov identifier (NCT number): NCT01221805

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United States, Illinois
Northwestern Medical Center
Chicago, Illinois, United States, 60611
United States, Indiana
Indiana University Health
Indianapolis, Indiana, United States, 46202
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Brigham and Woman's Hosp
Boston, Massachusetts, United States, 02115
United States, North Carolina
Moses Cone Memorial Hospital
Greensboro, North Carolina, United States, 27401
United States, Ohio
Univeristy Medical Center
Colombus, Ohio, United States, 43210
United States, Oklahoma
Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Lehigh Valley Hospital Health Network
Allentown, Pennsylvania, United States, 18103
United States, South Carolina
Medical Center of South Carolina
Charleston, South Carolina, United States, 29403
United States, Texas
Texas Health Fort Worth Hospital
Fort Worth, Texas, United States, 76104
Maisonneuve Rosemont Hospital
Montréal, Canada
University Hospital
Dijon, France
University Hospital
Grenoble, France, 38043
University Hospital
Bologna, Italy
IRCCS H San Raffaele
Milan, Italy
University Hospital
Alicante, Spain
General Hospital
Soria, Spain
Sponsors and Collaborators
Diagnostica Stago
University Hospital, Grenoble
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Principal Investigator: GILLES PERNOD, MD PhD University Hospital, Grenoble

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Diagnostica Stago
ClinicalTrials.gov Identifier: NCT01221805    
Other Study ID Numbers: DCIC 10 18
First Posted: October 15, 2010    Key Record Dates
Last Update Posted: August 5, 2016
Last Verified: August 2016
Keywords provided by Diagnostica Stago:
deep venous thrombosis
pulmonary embolism
venous thromboembolism
Wells score
Wells clinical pretest probability
Additional relevant MeSH terms:
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Pulmonary Embolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases