Status:
COMPLETED
STA®-Liatest®D-Di-Exclusion of Venous Thromboembolism
Lead Sponsor:
Diagnostica Stago
Collaborating Sponsors:
University Hospital, Grenoble
Conditions:
Deep Venous Thrombosis
Pulmonary Embolism
Eligibility:
All Genders
Up to 80 years
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 (DV...
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: *...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- 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
- EXCLUSION CRITERIA
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
2040 Patients enrolled
Trial Details
Trial ID
NCT01221805
Start Date
November 1 2011
End Date
April 1 2016
Last Update
August 5 2016
Active Locations (18)
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1
Northwestern Medical Center
Chicago, Illinois, United States, 60611
2
Indiana University Health
Indianapolis, Indiana, United States, 46202
3
University of Iowa
Iowa City, Iowa, United States, 52242
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114