ThRombosis ExclUsion STudy

Pulmonary Embolism Clinical Trial

— TRUST  

Official title:

ThRombosis ExclUsion STudy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03477968
• Other study ID #: TRUST study
• Status: Active, not recruiting
• Start date: June 25, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Diagnostica Stago
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 5000
• Est. completion date: December 31, 2024
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 80 Years

Eligibility

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 patients ability to participate in the study or to comply with follow-up requirements, or impact the scientific integrity of the study.

Related Conditions & MeSH terms

• Deep Venous Thromboses
• Embolism
• Pulmonary Embolism
• Thromboembolism
• Thrombosis
• Venous Thromboembolism
• Venous Thrombosis

Intervention

Diagnostic Test:
• DDimer test
Measuring the level of DDimer in blood sample

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires St Luc	Bruxelles
France	CHU	Angers
France	CHU	Dijon
France	CHU	Grenoble
France	CHU	Rouen
Italy	University Hospital S. Orsola-Mapighi	Bologna
Spain	Hospital Universitario Virgen del Rocio	Sevilla
Spain	General Hospital	Soria
United States	Lehigh Hospital	Allentown	Pennsylvania
United States	St Luke's University Health Network	Bethlehem	Pennsylvania
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Taylor regional Hospital	Campbellsville	Kentucky
United States	Northwestern Medical Center	Chicago	Illinois
United States	Ohio State University	Columbus	Ohio
United States	UT Southwestern	Dallas	Texas
United States	Duke Hemostasis and Thrombosis Research Center	Durham	North Carolina
United States	Indiana University Health	Indianapolis	Indiana
United States	Yale New Haven Hospital	New Haven	Connecticut
United States	Jefferson University Hospital	Philadelphia	Pennsylvania
United States	Washington University	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Diagnostica Stago

Countries where clinical trial is conducted

United States,  Belgium,  France,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VTE Exclusion	To demonstrate the ability of new D-Dimer assay combined with a clinical pretest probability (PTP) to safely exclude pulmonary embolism or deep venous thrombosis as measured by Negative Predictive Value and sensitivity	Up to 4 months for patients with 3 months follow-up