Deep Venous ThrombosesTRUSTNCT03477968
ThRombosis ExclUsion STudy
An observational study of Deep Venous Thromboses and Pulmonary Embolism, run by Diagnostica Stago at 20 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 79 years
- Conditions the study is for
- Deep Venous Thromboses, Pulmonary Embolism, Venous Thromboembolism
- What is being tested?
- DDimer test
- How many people
- 5,935 participants
- Where
- 20 sitesin 5 countries
- Study dates
- 25 Jun 2018to 5 Sep 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 79 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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),
Show all 19Show fewer
- 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.
Trial locations and contacts
20 sites in 5 countries.
20 sites in 5 countries
United States12 sites
Lehigh Hospital
Allentown, Pennsylvania, 18103
St Luke's University Health Network
Bethlehem, Pennsylvania, 18015
Massachusetts General Hospital
Boston, Massachusetts, 02114
Taylor regional Hospital
Campbellsville, Kentucky, 42718
Northwestern Medical Center
Chicago, Illinois, 60611
Ohio State University
Columbus, Ohio, 43210
UT Southwestern
Dallas, Texas, 75390
Duke Hemostasis and Thrombosis Research Center
Durham, North Carolina, 27710
Indiana University Health
Indianapolis, Indiana, 46202
Yale New Haven Hospital
New Haven, Connecticut, 06510
Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Washington University
St Louis, Missouri, 63110
Spain2 sites
Hospital Universitario Virgen del Rocio
Seville
General Hospital
Soria
About this study
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:
- To estimate additional STA® - Liatest® D-Di XL accuracy parameters, including specificity and positive predictive value (PPV)
- To constitute a plasma bank to be used for future studies with other DDi assays under development by Stago.
Read the 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.
- Being tested
- DDimer test
- Medical subject headings
- Venous Thrombosis, Pulmonary Embolism, Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DDimer testDiagnostic test
Measuring the level of DDimer in blood sample
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: DDimer test | |
| 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 Receives: Diagnostic Test: DDimer test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (1)
VTE Exclusion
According to the ThRombosis ExclUsion STudy (TRUST) protocol, the secondary objectives of the study were:
- To estimate additional STA® - Liatest® D-Di XL accuracy parameters, including specificity and positive predictive value (PPV)
- 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start25 Jun 2018
- Primary completion29 Mar 2023
- Study completion5 Sep 2024
Why it stopped: Due to the unstability of samples included in the plasmabank using the reference method: VIDAS system, Stago decided to not use the plasmabank to assess the pre-specified primary objective. Therefore, this study was halted prematurely.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Deep Venous ThrombosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,935 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diagnostica Stago
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03477968
- Sponsor's protocol ID
- TRUST study
- Acronym
- TRUST
- Status last verified
- Feb 2025
- First submitted
- 20 Mar 2018
- Last updated
- 25 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ThRombosis ExclUsion STudy
- ClinicalTrials.gov ID
- NCT03477968
- Acronym / sponsor ID
- TRUST / TRUST study
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Due to the unstability of samples included in the plasmabank using the reference method: VIDAS system, Stago decided to not use the plasmabank to assess the pre-specified primary objective. Therefore, this study was halted prematurely.
- Enrolment
- 5,935 participants (actual)
- Lead sponsor
- Diagnostica StagoIndustry (pharma, biotech, devices)
- Study start
- 25 Jun 2018 (actual)
- Primary completion
- 29 Mar 2023 (actual)
- Study completion
- 5 Sep 2024 (actual)
- First posted
- 27 Mar 2018 (actual)
- Results
- Posted 27 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To estimate additional STA® - Liatest® D-Di XL accuracy parameters, including specificity and positive predictive value (PPV)
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Embolism (PE) | – | Diagnostic Test: DDimer testPatients 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 |
| Deep Venous Thrombosis (DVT) | – | Diagnostic Test: DDimer testPatients 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 |
Who may qualify
- Ages
- Up to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- Patient is < 80 years old.
- Patient presents at least one of these symptoms indicative of proximal DVT or PE:
- 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.
Key exclusion criteria (19 listed)
- Patient presenting with a condition that may be associated with increased D-dimer levels, even in the absence of VTE, such as:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DDimer testMeasuring the level of DDimer in blood sample | Diagnostic test | Deep Venous Thrombosis (DVT), Pulmonary Embolism (PE) |
Primary outcome
VTE Exclusion
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.
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.
1 secondary outcome
VTE Exclusion
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deep Venous Thromboses and Pulmonary Embolism, run by Diagnostica Stago at 20 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, France, Spain, Belgium, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VTE Exclusion (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.