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

Completed

Conditions studied: Deep Venous Thrombosis, Pulmonary Embolism, D-dimer

In brief

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.

Key facts

Study ID

NCT01221805

Run by

Diagnostica Stago

People needed

2040

Starts

2011-11-01

Expected to finish

2016-04-01

Last updated by the study team

2016-08-05

Who can join

Age: any, up to 80. Sex: any. Healthy volunteers: not accepted.

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)
• Patients with known tissue plasminogen activator (tPA) deficiency
• Patient participating or who has participated within one month of enrollment in another investigational study
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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