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

NCT02078154 | Terminated DMC

• 1 other identifier: D-Dimer DVT
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

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,

Conditions

Deep Venous Thrombosis

Keywords

D-Dimer; DVT; Wells score

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• STA Liatest DDi Versus STA Liatest DDi Plus

  At the initial visit (up to 24 hours)

Other Outcomes (1)

• Plasma bank for DDi measurements

  At the initial visit (up to 24 hours)

Study Arms (1)

Deep Venous Thrombosis (DVT)

DVT diagnosed by imaging technique with a low or moderate Wells score

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

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

Sponsors & Collaborators

• Diagnostica Stago: lead

Study Sites (1)

The University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples

MeSH Terms

Conditions

Venous Thrombosis

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Suman Wasan Rathbun, MD

  University of Oklahoma Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2014
• First Posted: March 5, 2014
• Study Start: April 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: June 3, 2015

Record last verified: 2015-06

Locations

US (1)