TRUST: ThRombosis ExclUsion STudy

Sponsor

Diagnostica Stago (Industry)

Overall Status

Recruiting

CT.gov ID

NCT03477968

Collaborator

(none)

5,000

Enrollment

Locations

41.2

Anticipated Duration (Months)

250

Patients Per Site

6.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Deep Venous Thromboses Pulmonary Embolism Venous Thromboembolism	Other: Plasma sampling

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 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

Study Type:

Observational

Anticipated Enrollment :

5000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

ThRombosis ExclUsion STudy

Actual Study Start Date :

Jun 25, 2018

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	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	Other: Plasma sampling Additional blood draw or additional volume during blood draw
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	Other: Plasma sampling Additional blood draw or additional volume during blood draw

Arm

Intervention/Treatment

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

Other: Plasma sampling

Additional blood draw or additional volume during blood draw

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

Other: Plasma sampling

Additional blood draw or additional volume during blood draw

Outcome Measures

Primary Outcome Measures

VTE Exclusion [Up to 4 months for patients with 3 months follow-up]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yale New Haven Hospital	New Haven	Connecticut	United States	06510
2	Northwestern Medical Center	Chicago	Illinois	United States	60611
3	Indiana University Health	Indianapolis	Indiana	United States	46202
4	Taylor regional Hospital	Campbellsville	Kentucky	United States	42718
5	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
6	Washington University	Saint Louis	Missouri	United States	63110
7	Duke Hemostasis and Thrombosis Research Center	Durham	North Carolina	United States	27710
8	Ohio State University	Columbus	Ohio	United States	43210
9	Lehigh Hospital	Allentown	Pennsylvania	United States	18103
10	St Luke's University Health Network	Bethlehem	Pennsylvania	United States	18015
11	Jefferson University Hospital	Philadelphia	Pennsylvania	United States	19107
12	UT Southwestern	Dallas	Texas	United States	75390
13	Cliniques Universitaires St Luc	Bruxelles		Belgium
14	CHU	Angers		France
15	CHU	Dijon		France
16	CHU	Grenoble		France
17	CHU	Rouen		France
18	University Hospital S. Orsola-Mapighi	Bologna		Italy
19	Hospital Universitario Virgen del Rocio	Sevilla		Spain
20	General Hospital	Soria		Spain