ThRombosis ExclUsion STudy

Stopped early

Conditions studied: Deep Venous Thromboses, Pulmonary Embolism, Venous Thromboembolism

In brief

Primary objective: To demonstrate the ability of STA® - Liatest® D-Di XL combined with a clinical PreTest Probability (PTP) to safely exclude pulmonary embolism (PE) and deep venous thrombosis (DVT) as measured by Negative Predictive Value (NPV) and sensitivity. Secondary objectives: 1. To estimate additional STA® - Liatest® D-Di XL accuracy parameters, including specificity and positive predictive value (PPV) 2. To constitute a plasma bank to be used for future studies with other DDi assays under development by Stago.

Key facts

Study ID

NCT03477968

Run by

Diagnostica Stago

People needed

5935

Starts

2018-06-25

Expected to finish

2024-09-05

Last updated by the study team

2025-02-25

Who can join

Age: any, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient is < 80 years old.
• Patient presents 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
• 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,
• Disseminated intravascular coagulation
• 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 having delivered 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 regimen) started twenty four (24) hours or more before blood draw (except aspirin and platelet inhibitors)
• Previous anticoagulant therapy stopped less than three (3) months before blood draw (except aspirin and platelet inhibitors)
• 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 enrolment 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

• Yale New Haven Hospital — New Haven, Connecticut, United States
• Northwestern Medical Center — Chicago, Illinois, United States
• Indiana University Health — Indianapolis, Indiana, United States
• Taylor regional Hospital — Campbellsville, Kentucky, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Washington University — St Louis, Missouri, United States
• Duke Hemostasis and Thrombosis Research Center — Durham, North Carolina, United States
• Ohio State University — Columbus, Ohio, United States
• Lehigh Hospital — Allentown, Pennsylvania, United States
• St Luke's University Health Network — Bethlehem, Pennsylvania, United States
• Jefferson University Hospital — Philadelphia, Pennsylvania, United States
• UT Southwestern — Dallas, Texas, United States
• Cliniques Universitaires St Luc — Brussels, Belgium
• CHU — Angers, France
• CHU — Dijon, France
• CHU — Grenoble, France
• CHU — Rouen, France
• University Hospital S. Orsola-Mapighi — Bologna, Italy
• Hospital Universitario Virgen del Rocio — Seville, Spain
• General Hospital — Soria, Spain

Full record on ClinicalTrials.gov

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