Clinical trial NCT02078154: Measurement of D-Dimer Levels in Patients With Confirmed Deep Vein Thrombosis
Official title: Measurement of D-Dimer Levels in Patients With Confirmed Deep Vein Thrombosis
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Deep Venous Thrombosis
Keywords: D-Dimer
DVT
Wells score
Lead sponsor: Diagnostica Stago
Sponsor class: INDUSTRY
First posted: 2014-03-05
Enrollment: 6
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with proximal DVT diagnosed by imaging technique and with a low and moderate Wells score

Brief summary: 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,


Eligibility criteria: 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

Primary outcomes:
measure: STA Liatest DDi results in DVT positive cases
timeFrame: At the initial visit (up to 24 hours)
Secondary outcomes:
measure: STA Liatest DDi Versus STA Liatest DDi Plus
timeFrame: At the initial visit (up to 24 hours)
Other outcomes:
measure: Plasma bank for DDi measurements
timeFrame: At the initial visit (up to 24 hours)
Locations:
city: Oklahoma City
country: United States
facility: The University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma Health Sciences
name: Suman Wasan Rathbun, MD
role: PRINCIPAL_INVESTIGATOR
References: