Measurement of D-Dimer Levels in Patients With Confirmed Deep Vein Thrombosis

Stopped early

Conditions studied: Deep Venous Thrombosis

In brief

Measurement of D-Di (D-Dimer) levels using the in-vitro diagnostic reagent STA® - Liatest® D-Di and STA® - Liatest® D-Di PLUS in plasma samples from patients diagnosed with Deep Vein Thrombosis (DVT) Data from this study may be used in conjunction with data from the prospective study entitled "STA® - Liatest® D-Di - Exclusion of Venous Thromboembolism (VTE)", NCT01221805, the DiET study,

Key facts

Study ID

NCT02078154

Run by

Diagnostica Stago

People needed

6

Starts

2014-04-01

Expected to finish

2015-01-01

Last updated by the study team

2015-06-03

Who can join

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

You may qualify if…

• The study population tested will be recruited from ambulatory outpatients (presenting at the emergency unit or outpatient clinic) suspected of having DVT.
• Patient is < 80 years old.
• Patient presenting at least one of these symptoms indicative of proximal DVT: leg pain, tenderness (discomfort through palpation), leg swelling and /or edema,
• Patient has confirmed proximal DVT by imaging
• Low or moderate Wells score
• Patient provides written informed consent to participate in the sample collection

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 blood drawing for D-dimer testing

Where it is running

• The University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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