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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 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: September 8, 2014
Last verified: September 2014

October 12, 2010
September 8, 2014
November 2011
February 2015   (final data collection date for primary outcome measure)
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)
to demonstrate the ability of STA Liatest DDi combined with the Wells'pretest probability to safety exclude pulmonary embolism or deep venous thrombosis in a 3 months 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
Complete list of historical versions of study NCT01221805 on ClinicalTrials.gov Archive Site
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.
  • to determine the prognostic value of D-Dimer in patient for who venous thromboembolism was exclude [ Time Frame: at 3 months ] [ Designated as safety issue: Yes ]
    occurence of death, cardiovascular event and carcinoma during the 3 month follow-up
  • to determine the rate of distal deep venous thrombosis depending patient received a complete compression ultrasonography or a partial compression ultrasonography [ Time Frame: at 3 months ] [ Designated as safety issue: Yes ]
    occurence of distal deep venous thrombosis during the 3 month follow-up in patient with results imaging technique negative
  • To analyse results homogeneity in the group "positive D-dimer result and negative imaging result". [ Time Frame: at 3 months ] [ Designated as safety issue: Yes ]
    results homogeneity in the group "positive D-dimer result and negative imaging result".
Not Provided
Not Provided
 
STA®-Liatest®D-Di-Exclusion of Venous Thromboembolism
STA®-Liatest®D-Di-Exclusion of Venous Thromboembolism

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

plasma samples (at least 1 aliquot 0.5 ml) will be collected at the initial visit of patients with low or moderate PTP

Non-Probability Sample

The study population will be recruited from prospective, consecutive, ambulatory outpatients (presenting at the emergency unit or outpatient clinic) suspected of having venous thromboembolism

  • Deep Venous Thrombosis
  • Pulmonary Embolism
  • D-dimer
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2612
February 2015
February 2015   (final data collection date for primary outcome measure)

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
Both
up to 80 Years
No
Contact: Gilles PERNOD, MD PHD +33476765717 GPernod@chu-grenoble.fr
United States,   Canada,   France,   Italy,   Spain
 
NCT01221805
DCIC 10 18
No
Diagnostica Stago
Diagnostica Stago
University Hospital, Grenoble
Principal Investigator: GILLES PERNOD, MD PhD University Hospital, Grenoble
Diagnostica Stago
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP