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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Embolism; Deep Venous Thrombosis; 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.

• Study Type: Observational
• Enrollment (Actual): 2040

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	at 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at 3 months

Collaborators and Investigators

• Sponsor: Diagnostica Stago
• Collaborators: University Hospital, Grenoble
• Investigators: Principal Investigator: GILLES PERNOD, MD PhD, University Hospital, Grenoble

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: October 12, 2010
• First Submitted That Met QC Criteria: October 14, 2010
• First Posted (Estimate): October 15, 2010

Study Record Updates

• Last Update Posted (Estimate): August 5, 2016
• Last Update Submitted That Met QC Criteria: August 4, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: D-dimer; venous thromboembolism; pulmonary embolism; deep venous thrombosis; Wells score; Wells clinical pretest probability
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Thrombosis; Venous Thrombosis; Thromboembolism; Venous Thromboembolism; Pulmonary Embolism
• Other Study ID Numbers: DCIC 10 18