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

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ClinicalTrials.gov Identifier: NCT02078154
Recruitment Status : Terminated (Decision to start a new study on DVT with another protocol)
First Posted : March 5, 2014
Last Update Posted : June 3, 2015
Sponsor:
Information provided by (Responsible Party):
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,

Condition or disease
Deep Venous Thrombosis

Study Type : Observational
Actual Enrollment : 6 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Measurement of D-Dimer Levels in Patients With Confirmed Deep Vein Thrombosis
Study Start Date : April 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. STA Liatest DDi results in DVT positive cases [ Time Frame: 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 :
  1. STA Liatest DDi Versus STA Liatest DDi Plus [ Time Frame: 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


Other Outcome Measures:
  1. Plasma bank for DDi measurements [ Time Frame: 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 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


Biospecimen Retention:   Samples Without DNA
Plasma samples


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Ages Eligible for Study:   up to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with proximal DVT diagnosed by imaging technique and with a low and moderate Wells score
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02078154


Locations
United States, Oklahoma
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
Diagnostica Stago
Investigators
Principal Investigator: Suman Wasan Rathbun, MD University of Oklahoma Health Sciences

Responsible Party: Diagnostica Stago
ClinicalTrials.gov Identifier: NCT02078154     History of Changes
Other Study ID Numbers: D-Dimer DVT
First Posted: March 5, 2014    Key Record Dates
Last Update Posted: June 3, 2015
Last Verified: June 2015

Keywords provided by Diagnostica Stago:
D-Dimer
DVT
Wells score

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Fibrin fragment D
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants