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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Diagnostica Stago
Sponsor:
Collaborator:
University Hospital, Grenoble
Information provided by (Responsible Party):
Diagnostica Stago
ClinicalTrials.gov Identifier:
NCT01221805
First received: October 12, 2010
Last updated: February 28, 2014
Last verified: February 2014
  Purpose

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 Phase
Deep Venous Thrombosis
Pulmonary Embolism
D-dimer
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: STA®-Liatest®D-Di-Exclusion of Venous Thromboembolism

Resource links provided by NLM:


Further study details as provided by Diagnostica Stago:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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. 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 ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 2612
Study Start Date: November 2011
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   up to 80 Years
Genders Eligible for Study:   Both
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

Criteria

INCLUSION CRITERIA

  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

EXCLUSION CRITERIA

  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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01221805

Contacts
Contact: Gilles PERNOD, MD PHD +33476765717 GPernod@chu-grenoble.fr

Locations
United States, North Carolina
Moses Cone Memorial Hospital Recruiting
Greensboro, North Carolina, United States
Principal Investigator: Jay GROCE         
United States, Ohio
Univeristy Medical Center Completed
Colombus, Ohio, United States
United States, Pennsylvania
Lehigh Valley Hospital Health Network Recruiting
Allentown, Pennsylvania, United States
Principal Investigator: RICHARDSON David, MD         
United States, South Carolina
Medical Center of South Carolina Completed
Charleston, South Carolina, United States
Canada
Maisonneuve Rosemont Hospital Completed
Montréal, Canada
France
University Hospital Completed
Dijon, France
University Hospital Completed
Grenoble, France, 38043
Italy
University Hospital Completed
Bologna, Italy
IRCCS H San Raffaele Completed
Milan, Italy
Spain
University Hospital Completed
Alicante, Spain
General Hospital Completed
Soria, Spain
Sponsors and Collaborators
Diagnostica Stago
University Hospital, Grenoble
Investigators
Principal Investigator: GILLES PERNOD, MD PhD University Hospital, Grenoble
  More Information

Publications:

Responsible Party: Diagnostica Stago
ClinicalTrials.gov Identifier: NCT01221805     History of Changes
Other Study ID Numbers: DCIC 10 18
Study First Received: October 12, 2010
Last Updated: February 28, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Diagnostica Stago:
deep venous thrombosis
pulmonary embolism
venous thromboembolism
D-dimer
Wells score
Wells clinical pretest probability

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Thromboembolism
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 24, 2014