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

Terminated

• Conditions: Deep Venous Thrombosis

• Registration Number: NCT02078154
• Lead Sponsor: Diagnostica Stago

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,

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-26
• Study First Submitted QC: 2014-03-04
• Study First Posted: 2014-03-05
• Study Start: 2014-04
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-02
• Last Update Posted: 2015-06-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
STA Liatest DDi results in DVT positive cases	At the initial visit (up to 24 hours)	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.

Secondary Outcome Measures

Name	Time	Method
STA Liatest DDi Versus STA Liatest DDi Plus	At the initial visit (up to 24 hours)	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

Trial Locations

Locations (1)

The University of Oklahoma Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States