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Deep Venous ThrombosisDiETNCT01221805

STA®-Liatest®D-Di-Exclusion of Venous Thromboembolism

An observational study of Deep Venous Thrombosis and Pulmonary Embolism, run by Diagnostica Stago at 18 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 80 years
How many people
2,040 participants
Where
18 sitesin 5 countries
Study dates
Nov 2011to Apr 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • Patient is < 80 years old.
  • 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.
  • Patient provides written informed consent to participate in the study (or verbal no-opposition, as allowed by local regulations)
  • Patient is willing to comply with specified follow-up evaluation at 3 months and can be contacted by telephone

Who cannot join

  • 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,
Show all 18Show fewer
  • 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,
  • Patients presenting with a suspect thrombotic event related to catheter implantation
  • Ongoing therapeutic anticoagulants (curative and preventive treatment) starting twenty four (24) hours or more before the D-dimer is measured
  • Previous anticoagulant therapy stopped less than three (3) months before the D-dimer is measured
  • Patients with previous DVT/PE occurred less than three (3) months from screening.
  • Suspect thrombotic events in other locations at screening, including distal to the knee and upper extremity DVT (based on standard of care examinations)
  • Patients with known tissue plasminogen activator (tPA) deficiency
  • Patient participating or who has participated within one month of enrollment in another investigational study
  • 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

Trial locations and contacts

18 sites in 5 countries.

18 sites in 5 countries

United States11 sites

  • Lehigh Valley Hospital Health Network

    Allentown, Pennsylvania, 18103

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Brigham and Woman's Hosp

    Boston, Massachusetts, 02115

  • Medical Center of South Carolina

    Charleston, South Carolina, 29403

  • Northwestern Medical Center

    Chicago, Illinois, 60611

  • Univeristy Medical Center

    Colombus, Ohio, 43210

  • Texas Health Fort Worth Hospital

    Fort Worth, Texas, 76104

  • Moses Cone Memorial Hospital

    Greensboro, North Carolina, 27401

  • Indiana University Health

    Indianapolis, Indiana, 46202

  • University of Iowa

    Iowa City, Iowa, 52242

  • Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

Other trials in United States

France2 sites

  • University Hospital

    Dijon

  • University Hospital

    Grenoble, 38043

Other trials in France

Italy2 sites

  • University Hospital

    Bologna

  • IRCCS H San Raffaele

    Milan

Other trials in Italy

Spain2 sites

  • University Hospital

    Alicante

  • General Hospital

    Soria

Other trials in Spain

Canada1 site

  • Maisonneuve Rosemont Hospital

    Montreal

Other trials in Canada

About this study

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.

Read the 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.

Keywords
deep venous thrombosis, pulmonary embolism, venous thromboembolism, D-dimer, Wells score, Wells clinical pretest probability
Medical subject headings
Venous Thrombosis, Pulmonary Embolism, Venous Thromboembolism

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    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)

    Measured: at 3 months

Secondary outcomes (1)

  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

    1. Prevalence of VTE in PTP high patients based on imaging results.

    Measured: at 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2010 (estimated)
  2. Study startNov 2011
  3. Primary completionMar 2016
  4. Study completionApr 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,040 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01221805
Sponsor's protocol ID
DCIC 10 18
Acronym
DiET
Status last verified
Aug 2016
First submitted
12 Oct 2010
Last updated
5 Aug 2016
Results posted
No
Data monitoring committee
No

Publications

  • Keeling DM, Mackie IJ, Moody A, Watson HG; Haemostasis and Thrombosis Task Force of the British Committee for Standards in Haematology. The diagnosis of deep vein thrombosis in symptomatic outpatients and the potential for clinical assessment and D-dimer assays to reduce the need for diagnostic imaging. Br J Haematol. 2004 Jan;124(1):15-25. doi: 10.1046/j.1365-2141.2003.04723.x. No abstract available.

    PubMed 14675404

  • Goekoop RJ, Steeghs N, Niessen RW, Jonkers GJ, Dik H, Castel A, Werker-van Gelder L, Vlasveld LT, van Klink RC, Planken EV, Huisman MV. Simple and safe exclusion of pulmonary embolism in outpatients using quantitative D-dimer and Wells' simplified decision rule. Thromb Haemost. 2007 Jan;97(1):146-50.

    PubMed 17200782

  • Kelly J, Hunt BJ. A clinical probability assessment and D-dimer measurement should be the initial step in the investigation of suspected venous thromboembolism. Chest. 2003 Sep;124(3):1116-9. No abstract available.

    PubMed 12970044

  • Pasha SM, Klok FA, Snoep JD, Mos IC, Goekoop RJ, Rodger MA, Huisman MV. Safety of excluding acute pulmonary embolism based on an unlikely clinical probability by the Wells rule and normal D-dimer concentration: a meta-analysis. Thromb Res. 2010 Apr;125(4):e123-7. doi: 10.1016/j.thromres.2009.11.009. Epub 2009 Nov 26.

    PubMed 19942258

  • Perrier A, Desmarais S, Goehring C, de Moerloose P, Morabia A, Unger PF, Slosman D, Junod A, Bounameaux H. D-dimer testing for suspected pulmonary embolism in outpatients. Am J Respir Crit Care Med. 1997 Aug;156(2 Pt 1):492-6. doi: 10.1164/ajrccm.156.2.9702032.

    PubMed 9279229

  • Wells PS, Anderson DR, Rodger M, Forgie M, Kearon C, Dreyer J, Kovacs G, Mitchell M, Lewandowski B, Kovacs MJ. Evaluation of D-dimer in the diagnosis of suspected deep-vein thrombosis. N Engl J Med. 2003 Sep 25;349(13):1227-35. doi: 10.1056/NEJMoa023153.

    PubMed 14507948

  • Pernod G, Caterino J, Maignan M, Tissier C, Kassis J, Lazarchick J; DIET study group. D-Dimer Use and Pulmonary Embolism Diagnosis in Emergency Units: Why Is There Such a Difference in Pulmonary Embolism Prevalence between the United States of America and Countries Outside USA? PLoS One. 2017 Jan 13;12(1):e0169268. doi: 10.1371/journal.pone.0169268. eCollection 2017.

    PubMed 28085911

Questions about this trial

What is this clinical trial studying?

An observational study of Deep Venous Thrombosis and Pulmonary Embolism, run by Diagnostica Stago at 18 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States, France, Italy, Spain, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01221805, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2016.

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