Clinical trial NCT03477968: ThRombosis ExclUsion STudy
Official title: ThRombosis ExclUsion STudy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Deep Venous Thromboses
Pulmonary Embolism
Venous Thromboembolism
Lead sponsor: Diagnostica Stago
Sponsor class: INDUSTRY
First posted: 2018-03-27
Enrollment: 5935
Sex: ALL
Maximum age (years): 79
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will be recruited from prospective, consecutive, ambulatory outpatients (presenting at the emergency unit or outpatient clinic) suspected of having VTE. Patients with DVT and PE will be analyzed as separate groups.

Brief summary: Primary objective: To demonstrate the ability of STA® - Liatest® D-Di XL combined with a clinical PreTest Probability (PTP) to safely exclude pulmonary embolism (PE) and deep venous thrombosis (DVT) as measured by Negative Predictive Value (NPV) and sensitivity.

Secondary objectives:

1. To estimate additional STA® - Liatest® D-Di XL accuracy parameters, including specificity and positive predictive value (PPV)
2. To constitute a plasma bank to be used for future studies with other DDi assays under development by Stago.

Detailed description: The study population will be selected from prospective, consecutive ambulatory outpatients suspected of having venous thromboembolism. Patients will be diagnosed for VTE (PE or DVT) based on local standard of care. Samples will be collected (additional blood draw or additional volume during blood draw) for future testing with new D-Dimer assay.

In case of Low/Moderate PTP score and negative VTE diagnosis, patients will be followed for 3 months to evaluate potential development of deep venous thrombosis and/or pulmonary embolism.

Eligibility criteria: Inclusion Criteria:

1. Patient is \< 80 years old.
2. Patient presents 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.
3. Patient provides written informed consent to participate in the study
4. Patient is willing to comply with specified follow-up evaluation at 3 months and can be contacted by telephone.

Exclusion Criteria:

1. 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,
   * Disseminated intravascular coagulation
   * 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 having delivered 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,
2. Patients presenting with a suspect thrombotic event related to catheter implantation
3. Ongoing therapeutic anticoagulants (curative and preventive regimen) started twenty four (24) hours or more before blood draw (except aspirin and platelet inhibitors)
4. Previous anticoagulant therapy stopped less than three (3) months before blood draw (except aspirin and platelet inhibitors)
5. Patients with previous DVT/PE occurred less than three (3) months from screening.
6. Suspect thrombotic events in other locations at screening, including distal to the knee and upper extremity DVT (based on standard of care examinations)
7. Patients with known tissue plasminogen activator (tPA) deficiency
8. Patient participating or who has participated within one month of enrolment in another investigational study
9. 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.

Primary outcomes:
measure: VTE Exclusion
timeFrame: Initially, we planned to enroll subjects suspected of PE/DVT to constitute a plasmabank, then perform testing of STA- Liatest D-Di XL for on this latter on 48 months. However due to plasmabank unstability, Stago decided to not perform the testing phase.
Secondary outcomes:
measure: VTE Exclusion
timeFrame: Initially, we planned to enroll subjects suspected of PE/DVT to constitute a plasmabank, then perform testing of STA- Liatest D-Di XL. Due to plasmabank unstability, Stago decided to not perform the testing phase for the STA-D-Di XL and future DDi assays.
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Chicago
country: United States
facility: Northwestern Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Health
state: Indiana
city: Campbellsville
country: United States
facility: Taylor regional Hospital
state: Kentucky
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Durham
country: United States
facility: Duke Hemostasis and Thrombosis Research Center
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Allentown
country: United States
facility: Lehigh Hospital
state: Pennsylvania
city: Bethlehem
country: United States
facility: St Luke's University Health Network
state: Pennsylvania
city: Philadelphia
country: United States
facility: Jefferson University Hospital
state: Pennsylvania
city: Dallas
country: United States
facility: UT Southwestern
state: Texas
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires St Luc
city: Angers
country: France
facility: CHU
city: Dijon
country: France
facility: CHU
city: Grenoble
country: France
facility: CHU
city: Rouen
country: France
facility: CHU
city: Bologna
country: Italy
facility: University Hospital S. Orsola-Mapighi
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Soria
country: Spain
facility: General Hospital
Study officials:
References: