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

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,

Study Overview

• Status: Terminated
• Conditions: Deep Venous Thrombosis

• Study Type: Observational
• Enrollment (Actual): 6

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • The University of Oklahoma Health Sciences Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with proximal DVT diagnosed by imaging technique and with a low and moderate Wells score

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Deep Venous Thrombosis (DVT); DVT diagnosed by imaging technique with a low or moderate Wells score

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
STA Liatest DDi results in DVT positive cases	Prospective, ambulatory outpatients (presenting to the emergency unit or outpatient clinic) suspected of having DVT, with a proximal positive imaging results, will be screened for eligibility using the inclusion and exclusion criteria (see Section above). Then the eligible patients will be evaluated using the Wells score and only patient with Low or moderate Pre-Test Probability (PTP) will receive full explanation concerning nature, objectives and risks associated to the participation in this study. Written informed consent will be obtained from each participating subject prior blood drawing, processing, plasma aliquoting and freezing at -80°C for D-Dimer testing (STA Liatest DDi). The whole process, starting from the moment the patient is diagnosed with DVT, should not exceed 24 hours.	At the initial visit (up to 24 hours)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
STA Liatest DDi Versus STA Liatest DDi Plus	Prospective, ambulatory outpatients (presenting to the emergency unit or outpatient clinic) suspected of having DVT, with a proximal positive imaging results, will be screened for eligibility using the inclusion and exclusion criteria (see Section above). Then the eligible patients will be evaluated using the Wells score and only patient with Low or moderate PTP will receive full explanation concerning nature, objectives and risks associated to the participation in this study. Written informed consent will be obtained from each participating subject prior blood drawing, processing, plasma aliquoting and freezing at -80°C for D-Dimer testing (STA Liatest DDi Plus). The whole process, starting from the moment the patient is diagnosed with DVT, should not exceed 24 hours	At the initial visit (up to 24 hours)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma bank for DDi measurements	Prospective, ambulatory outpatients (presenting to the emergency unit or outpatient clinic) suspected of having DVT, with a proximal positive imaging results, will be screened for eligibility using the inclusion and exclusion criteria (see Section above). Then the eligible patients will be evaluated using the Wells score and only patient with Low or moderate PTP will receive full explanation concerning nature, objectives and risks associated to the participation in this study. Written informed consent will be obtained from each participating subject prior blood drawing, processing, plasma aliquoting and freezing at -80°C for D-Dimer testing (STA Liatest DDi or STA Liatest DDi Plus to investigate unmatched results). The whole process, starting from the moment the patient is diagnosed with DVT, should not exceed 24 hours	At the initial visit (up to 24 hours)

Collaborators and Investigators

• Sponsor: Diagnostica Stago
• Investigators: Principal Investigator: Suman Wasan Rathbun, MD, University of Oklahoma Health Sciences

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: February 26, 2014
• First Submitted That Met QC Criteria: March 4, 2014
• First Posted (Estimate): March 5, 2014

Study Record Updates

• Last Update Posted (Estimate): June 3, 2015
• Last Update Submitted That Met QC Criteria: June 2, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: D-Dimer; DVT; Wells score
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis
• Other Study ID Numbers: D-Dimer DVT