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

NCT01221805 | Completed

• 1 other identifier: DCIC 10 18
• Study Type: observational
• Target: 2,040
• Locations: 5 countries
• Sites: 18

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.

Conditions

Deep Venous Thrombosis; Pulmonary Embolism; D-dimer

Keywords

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

Outcome Measures

Primary Outcomes (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)

  at 3 months

Secondary Outcomes (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

  at 3 months

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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,
• 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)

Sponsors & Collaborators

• Diagnostica Stago: lead
• University Hospital, Grenoble: collaborator

Study Sites (18)

Northwestern Medical Center

Chicago, Illinois, 60611, United States

Location

Indiana University Health

Indianapolis, Indiana, 46202, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Woman's Hosp

Boston, Massachusetts, 02115, United States

Location

Moses Cone Memorial Hospital

Greensboro, North Carolina, 27401, United States

Location

Univeristy Medical Center

Colombus, Ohio, 43210, United States

Location

Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Lehigh Valley Hospital Health Network

Allentown, Pennsylvania, 18103, United States

Location

Medical Center of South Carolina

Charleston, South Carolina, 29403, United States

Location

Texas Health Fort Worth Hospital

Fort Worth, Texas, 76104, United States

Location

Maisonneuve Rosemont Hospital

Montreal, Canada

Location

University Hospital

Dijon, France

Location

University Hospital

Grenoble, 38043, France

Location

University Hospital

Bologna, Italy

Location

IRCCS H San Raffaele

Milan, Italy

Location

University Hospital

Alicante, Spain

Location

General Hospital

Soria, Spain

Location

Related Publications (7)

• 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.

  PMID: 14675404 BACKGROUND

• 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.

  PMID: 17200782 BACKGROUND

• 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.

  PMID: 12970044 BACKGROUND

• 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.

  PMID: 19942258 BACKGROUND

• 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.

  PMID: 9279229 BACKGROUND

• 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.

  PMID: 14507948 BACKGROUND

• 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.

  PMID: 28085911 DERIVED

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

MeSH Terms

Conditions

Venous Thrombosis; Pulmonary Embolism; Venous Thromboembolism

Condition Hierarchy (Ancestors)

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

Study Officials

• GILLES PERNOD, MD PhD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2010
• First Posted: October 15, 2010
• Study Start: November 1, 2011
• Primary Completion: March 1, 2016
• Study Completion: April 1, 2016
• Last Updated: August 5, 2016

Record last verified: 2016-08

Locations

ES (2); FR (2); US (11); IT (2); CA (1)