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

NCT ID: NCT01221805

Last Updated: 2016-08-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2040 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2016-04-30

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.

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.

Conditions

Deep Venous Thrombosis; Pulmonary Embolism; D-dimer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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

• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Grenoble

OTHER

Sponsor Role: collaborator

Diagnostica Stago

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GILLES PERNOD, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

Northwestern Medical Center

Chicago, Illinois, United States

Indiana University Health

Indianapolis, Indiana, United States

University of Iowa

Iowa City, Iowa, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Brigham and Woman's Hosp

Boston, Massachusetts, United States

Moses Cone Memorial Hospital

Greensboro, North Carolina, United States

Univeristy Medical Center

Colombus, Ohio, United States

Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Lehigh Valley Hospital Health Network

Allentown, Pennsylvania, United States

Medical Center of South Carolina

Charleston, South Carolina, United States

Texas Health Fort Worth Hospital

Fort Worth, Texas, United States

Maisonneuve Rosemont Hospital

Montreal, , Canada

University Hospital

Dijon, , France

University Hospital

Grenoble, , France

University Hospital

Bologna, , Italy

IRCCS H San Raffaele

Milan, , Italy

University Hospital

Alicante, , Spain

General Hospital

Soria, , Spain

Countries

United States; Canada; France; Italy; Spain

References

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.

Reference Type: BACKGROUND

PMID: 14675404 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17200782 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12970044 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19942258 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9279229 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14507948 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28085911 (View on PubMed)

Other Identifiers

DCIC 10 18

Identifier Type: -

Identifier Source: org_study_id