STA®-Liatest®D-Di-Exclusion of Venous Thromboembolism (DiET)

D

Diagnostica Stago

Status

Completed

Conditions

Pulmonary Embolism
Deep Venous Thrombosis
D-dimer

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT01221805
DCIC 10 18

Details and patient eligibility

About

The purpose of this study is to demonstrate the ability of STA® Liatest® D-Di combined with a clinical pretest probability (PTP) to safely exclude pulmonary embolism (PE) or Deep Venous Thrombosis (DVT) in a 3 month follow-up.

Full description

The study population will be selected from prospective, consecutive ambulatory outpatients suspected of having venous thromboembolism. These patients will first be evaluated using the Wells score: patients with low or moderate pretest probability will be considered for D-dimer testing, those with D-dimer positive will be considered for an imaging procedure, patients with high pretest probability will be considered for an imaging procedure. Patients with "low or moderate" pretest probability and a negative D-Dimer result will be followed for 3 months to evaluate potential development of deep venous thrombosis and/or pulmonary embolism. These patients will be contacted by phone 3 month after their first visit.

Enrollment

2,040 patients

Sex

All

Ages

Under 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

INCLUSION CRITERIA

Patient is < 80 years old.

Patient presenting at least one of these symptoms indicative of proximal DVT or PE:

  • symptoms for proximal DVT: leg pain, tenderness (discomfort through palpation), leg swelling, and /or edema,
  • symptoms for PE: hemoptysis, lung related chest pain, dyspnea.
  • Patient provides written informed consent to participate in the study (or verbal no-opposition, as allowed by local regulations)
  • Patient is willing to comply with specified follow-up evaluation at 3 months and can be contacted by telephone

EXCLUSION CRITERIA

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 D-dimer is measured
  • Previous anticoagulant therapy stopped less than three (3) months before the D-dimer is measured
  • Patients with previous DVT/PE occurred less than three (3) months from screening.
  • Suspect thrombotic events in other locations at screening, including distal to the knee and upper extremity DVT (based on standard of care examinations)
  • Patients with known tissue plasminogen activator (tPA) deficiency
  • Patient participating or who has participated within one month of enrollment in another investigational study
  • Major co-morbid condition(s) or other reasons that could limit the patient's ability to participate in the study or to comply with follow-up requirements, or impact the scientific integrity of the study

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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