ThRombosis ExclUsion STudy

Terminated

Conditions: Pulmonary Embolism
Deep Venous Thromboses
Venous Thromboembolism

Interventions: Diagnostic Test: DDimer test

Registration Number: NCT03477968

Lead Sponsor: Diagnostica Stago

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 5935

Inclusion Criteria

Patient is < 80 years old.
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.
Patient provides written informed consent to participate in the study
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,
- 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,
Patients presenting with a suspect thrombotic event related to catheter implantation
Ongoing therapeutic anticoagulants (curative and preventive regimen) started twenty four (24) hours or more before blood draw (except aspirin and platelet inhibitors)
Previous anticoagulant therapy stopped less than three (3) months before blood draw (except aspirin and platelet inhibitors)
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 enrolment 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.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PE	DDimer test	Patients presenting with PE suspicion. Diagnosis will be performed according to Standard of Care. Plasma samples will be collected if PTP score is Low or Moderate. If diagnosis is negative, patients will be followed for 3 months to evaluate potential VTE development. Enrolment completed for this group : 13th February 2020
DVT	DDimer test	Patients presenting with DVT suspicion. Diagnosis will be performed according to Standard of Care. Plasma samples will be collected if PTP score is Low or Moderate. If diagnosis is negative, patients will be followed for 3 months to evaluate potential VTE development. Enrolment on going

Primary Outcome Measures

Name	Time	Method
VTE Exclusion	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.	According to the ThRombosis ExclUsion STudy (TRUST) protocol, the primary objective of the study was to demonstrate the ability of STA® - Liatest® D-Di XL combined with a clinical PreTest Probability to safely exclude pulmonary embolism (PE) and deep venous thrombosis (DVT) as measured by Negative Predictive Value (NPV) and sensitivity. The first step was to evaluate the stability of the plasmabank using VIDAS system. The preliminary results showed that the plasmabank was unusable with a high rate of unstable samples. Stago, decided to not use this plasmabank to assess the ability of STA® - Liatest® D-Di XL to safely exclude PE and DVT.

Secondary Outcome Measures

Name	Time	Method
VTE Exclusion	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.	According to the ThRombosis ExclUsion STudy (TRUST) protocol, the secondary objectives of the study were: 1. To estimate additional STA® - Liatest® D-Di XL accuracy parameters, including specificity and positive predictive value (PPV) 2. To constitute a plasmabank to be used for future studies with other DDi assays under development by Stago. The first step was to evaluate the stability of the plasmabank using VIDAS system. The preliminary results showed that the plasmabank was unusable with a high rate of unstable samples. Stago, decided to not use this plasmabank to assess the ability of STA® - Liatest® D-Di XL to safely exclude PE and DVT and to not use this plasmabank for future studies with other DDi assays under development by Stago.

Trial Locations

Locations (17): Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
Northwestern Medical Center
🇺🇸
Chicago, Illinois, United States
Washington University
🇺🇸
Saint Louis, Missouri, United States
Taylor regional Hospital
🇺🇸
Campbellsville, Kentucky, United States
Ohio State University
🇺🇸
Columbus, Ohio, United States
Lehigh Hospital
🇺🇸
Allentown, Pennsylvania, United States
Jefferson University Hospital
🇺🇸
Philadelphia, Pennsylvania, United States
St Luke's University Health Network
🇺🇸
Bethlehem, Pennsylvania, United States
UT Southwestern
🇺🇸
Dallas, Texas, United States
Cliniques Universitaires St Luc
🇧🇪
Bruxelles, Belgium
CHU
🇫🇷
Rouen, France
Hospital Universitario Virgen del Rocio
🇪🇸
Sevilla, Spain
University Hospital S. Orsola-Mapighi
🇮🇹
Bologna, Italy
General Hospital
🇪🇸
Soria, Spain
Indiana University Health
🇺🇸
Indianapolis, Indiana, United States
Duke Hemostasis and Thrombosis Research Center
🇺🇸
Durham, North Carolina, United States
Yale New Haven Hospital
🇺🇸
New Haven, Connecticut, United States