Deep Venous Thromboses, Pulmonary Embolism, Venous Thromboembolism
Conditions
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.
Interventions
DIAGNOSTIC_TESTDDimer test
Measuring the level of DDimer in blood sample
Sponsors
Diagnostica Stago
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 79 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Belgium, France, Italy, Spain, United States
Participant flow
Pre-assignment details
As STA® - Liatest® D-Di XL was not available for testing before the end of the collection, it was not possible to anticipate the number of samples that might be lost during thawing due to stability. We decided to apply a 15% increase to the number of positives. Taking into account the decision to enroll N = 115 evaluable reference-positive subjects for each indication, sample size had to be recalculated. At study end, a total of 3,584 PE and 2,351 DVT subjects had been enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Pulmonary Embolism (PE) 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
DDimer test: Measuring the level of DDimer in blood sample | 2,778 |
| Deep Venous Thrombosis (DVT) 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 completed for this group : 29th March 2023
DDimer test: Measuring the level of DDimer in blood sample | 1,622 |
| Total | 4,400 |
Baseline characteristics
| Characteristic | Deep Venous Thrombosis (DVT) | Total | Pulmonary Embolism (PE) |
|---|---|---|---|
| Age, Continuous Deep Venous Thrombosis (DVT) Participants | 51.9 years STANDARD_DEVIATION 14.7 | 51.9 years STANDARD_DEVIATION 14.7 | — |
| Age, Continuous Pulmonary Embolism (PE) Participants | — | 45.8 years STANDARD_DEVIATION 15.2 | 45.8 years STANDARD_DEVIATION 15.2 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Sex: Female, Male Female | 994 Participants | 2669 Participants | 1675 Participants |
| Sex: Female, Male Male | 628 Participants | 1731 Participants | 1103 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
VTE Exclusion
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.
Time frame: 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.
Population: As described in the Protocol Section, the study was halted prematurely, therefore there is no Outcome Measure data.
Secondary
VTE Exclusion
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.
Time frame: 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.
Population: As described in the Protocol Section, the study was halted prematurely, therefore there is no Outcome Measure data.