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

Pulmonary Embolism Clinical Trial

— DiET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01221805
• Other study ID #: DCIC 10 18
• Status: Completed
• Phase: Phase 4
• First received: October 12, 2010
• Last updated: August 4, 2016
• Start date: November 2011
• Est. completion date: April 2016

Study information

• Verified date: August 2016
• Source: Diagnostica Stago
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2040
• Est. completion date: April 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 80 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• D-dimer
• Deep Venous Thrombosis
• Embolism
• Pulmonary Embolism
• Thromboembolism
• Thrombosis
• Venous Thromboembolism
• Venous Thrombosis

Locations

Country	Name	City	State
Canada	Maisonneuve Rosemont Hospital	Montréal
France	University Hospital	Dijon
France	University Hospital	Grenoble
Italy	University Hospital	Bologna
Italy	IRCCS H San Raffaele	Milan
Spain	University Hospital	Alicante
Spain	General Hospital	Soria
United States	Lehigh Valley Hospital Health Network	Allentown	Pennsylvania
United States	Brigham and Woman's Hosp	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Medical Center of South Carolina	Charleston	South Carolina
United States	Northwestern Medical Center	Chicago	Illinois
United States	Univeristy Medical Center	Colombus	Ohio
United States	Texas Health Fort Worth Hospital	Fort Worth	Texas
United States	Moses Cone Memorial Hospital	Greensboro	North Carolina
United States	Indiana University Health	Indianapolis	Indiana
United States	University of Iowa	Iowa City	Iowa
United States	Oklahoma Health Sciences Center	Oklahoma City	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
Diagnostica Stago	University Hospital, Grenoble

Countries where clinical trial is conducted

United States,  Canada,  France,  Italy,  Spain, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes