ThRombosis ExclUsion STudy

NCT03477968 | Terminated Results FDA Device

• 1 other identifier: TRUST study
• Study Type: observational
• Target: 5,935
• Locations: 5 countries
• Sites: 20

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

Conditions

Deep Venous Thromboses; Pulmonary Embolism; Venous Thromboembolism

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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.

Study Arms (2)

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

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

Diagnostic Test: DDimer test

Interventions

DDimer test DIAGNOSTIC_TEST

Measuring the level of DDimer in blood sample

Deep Venous Thrombosis (DVT); Pulmonary Embolism (PE)

Eligibility Criteria

• Age: Up to 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Diagnostica Stago: lead

Study Sites (20)

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Northwestern Medical Center

Chicago, Illinois, 60611, United States

Location

Indiana University Health

Indianapolis, Indiana, 46202, United States

Location

Taylor regional Hospital

Campbellsville, Kentucky, 42718, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Duke Hemostasis and Thrombosis Research Center

Durham, North Carolina, 27710, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Lehigh Hospital

Allentown, Pennsylvania, 18103, United States

Location

St Luke's University Health Network

Bethlehem, Pennsylvania, 18015, United States

Location

Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

UT Southwestern

Dallas, Texas, 75390, United States

Location

Cliniques Universitaires St Luc

Brussels, Belgium

Location

CHU

Angers, France

Location

CHU

Dijon, France

Location

CHU

Grenoble, France

Location

CHU

Rouen, France

Location

University Hospital S. Orsola-Mapighi

Bologna, Italy

Location

Hospital Universitario Virgen del Rocio

Seville, Spain

Location

General Hospital

Soria, Spain

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples

MeSH Terms

Conditions

Venous Thrombosis; Pulmonary Embolism; Venous Thromboembolism

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism; Thromboembolism

Results Point of Contact

• Title: Nathalie THUILLIER
• Organization: Diagnostica STAGO S.A.S

nathalie.thuillier@stago.com

+33 146 882 167

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2018
• First Posted: March 27, 2018
• Study Start: June 25, 2018
• Primary Completion: March 29, 2023
• Study Completion: September 5, 2024
• Last Updated: February 25, 2025
• Results First Posted: January 27, 2025

Record last verified: 2025-02

Locations

FR (4); ES (2); IT (1); BE (1); US (12)