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

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

Study Description

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.

Study Design

• 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

Groups and Cohorts

Outcome Measures

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

Eligibility Criteria

• 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

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

Locations

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

Canada

Maisonneuve Rosemont Hospital

Montréal, Canada

France

University Hospital

Dijon, France

University Hospital

Grenoble, France, 38043

Italy

University Hospital

Bologna, Italy

IRCCS H San Raffaele

Milan, Italy

Spain

University Hospital

Alicante, Spain

General Hospital

Soria, Spain

Sponsors and Collaborators

Diagnostica Stago

University Hospital, Grenoble

Investigators

• Principal Investigator: GILLES PERNOD, MD PhD; University Hospital, Grenoble

More Information

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Diagnostica Stago
• ClinicalTrials.gov Identifier: NCT01221805
• Other Study ID Numbers: DCIC 10 18
• First Posted: October 15, 2010
• Last Update Posted: August 5, 2016
• Last Verified: August 2016

Keywords provided by Diagnostica Stago:

deep venous thrombosis; pulmonary embolism; venous thromboembolism; D-dimer; Wells score; Wells clinical pretest probability

Additional relevant MeSH terms:

Pulmonary Embolism; Thrombosis; Embolism; Thromboembolism; Venous Thromboembolism; Venous Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases