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



Status:Completed
Conditions:Cardiology, Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any - 80
Updated:7/11/2015
Start Date:April 2014
End Date:April 2015
Contact:SUMAN WASAN RATHBUN, MD
Email:suman-rathbun@ouhsc.edu
Phone:405-271-4742

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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,


Inclusion Criteria:

- 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

Exclusion Criteria:

- Patient presenting with a condition that may be associated with increased D-dimer
levels, even in the absence of VTE, such as:

1. Fibrinolytic therapy within the previous seven (7) days,

2. Bone fracture or surgery (with general anesthesia longer than thirty (30)
minutes) within the previous one (1) month,

3. Deep hematoma diagnosed by imaging techniques within the previous one (1) month,

4. 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),

5. Sepsis, severe infections, pneumonia within the previous 1 month,

6. Known liver cirrhosis,

7. Pregnancy or post-partum within the previous 1 month,

8. Atherosclerotic vascular disease thrombosis within the previous 1month (e.g.
myocardial infarction, stroke, coronary syndrome, peripheral artery disease
stage III or IV),

9. 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
We found this trial at
1
site
940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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Oklahoma City, OK
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