Status:
TERMINATED
ThRombosis ExclUsion STudy
Lead Sponsor:
Diagnostica Stago
Conditions:
Deep Venous Thromboses
Pulmonary Embolism
Eligibility:
All Genders
Up to 79 years
Brief Summary
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) a...
Detailed Description
The study population will be selected from prospective, consecutive ambulatory outpatients suspected of having venous thromboembolism. Patients will be diagnosed for VTE (PE or DVT) based on local sta...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 25 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 5 2024
Estimated Enrollment :
5935 Patients enrolled
Trial Details
Trial ID
NCT03477968
Start Date
June 25 2018
End Date
September 5 2024
Last Update
February 25 2025
Active Locations (20)
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1
Yale New Haven Hospital
New Haven, Connecticut, United States, 06510
2
Northwestern Medical Center
Chicago, Illinois, United States, 60611
3
Indiana University Health
Indianapolis, Indiana, United States, 46202
4
Taylor regional Hospital
Campbellsville, Kentucky, United States, 42718