ThRombosis ExclUsion STudy (TRUST)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Venous Thromboembolism; Pulmonary Embolism; Deep Venous Thromboses
• Intervention / Treatment: Diagnostic test: DDimer test

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 Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles, Belgium
    • Cliniques Universitaires St Luc
• France
  • Angers, France
    • CHU
  • Dijon, France
    • CHU
  • Grenoble, France
    • CHU
  • Rouen, France
    • CHU
• Italy
  • Bologna, Italy
    • University Hospital S. Orsola-Mapighi
• Spain
  • Sevilla, Spain
    • Hospital Universitario Virgen del Rocio
  • Soria, Spain
    • General Hospital
• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale New Haven Hospital
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Medical Center
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Health
  • Kentucky
    • Campbellsville, Kentucky, United States, 42718
      • Taylor regional Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Hemostasis and Thrombosis Research Center
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Lehigh Hospital
    • Bethlehem, Pennsylvania, United States, 18015
      • St Luke's University Health Network
    • Philadelphia, Pennsylvania, United States, 19107
      • Jefferson University Hospital
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 78 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Measuring the level of DDimer in blood sample
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 on going	Diagnostic test: DDimer test; Measuring the level of DDimer in blood sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Diagnostica Stago

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2018
• Primary Completion (Actual): March 31, 2023
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: March 20, 2018
• First Submitted That Met QC Criteria: March 20, 2018
• First Posted (Actual): March 27, 2018

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Thrombosis; Venous Thrombosis; Thromboembolism; Venous Thromboembolism; Pulmonary Embolism
• Other Study ID Numbers: TRUST study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No