DiET: STA®-Liatest®D-Di-Exclusion of Venous Thromboembolism

Sponsor

Diagnostica Stago (Industry)

Overall Status

Completed

CT.gov ID

NCT01221805

Collaborator

University Hospital, Grenoble (Other)

2,040

Enrollment

Locations

Duration (Months)

113.3

Patients Per Site

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to demonstrate the ability of STA® Liatest® D-Di 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 Thrombosis Pulmonary Embolism D-dimer

Detailed Description

The study population will be selected from prospective, consecutive ambulatory outpatients suspected of having venous thromboembolism.

These patients will first be evaluated using the Wells score:

patients with low or moderate pretest probability will be considered for D-dimer testing, those with D-dimer positive will be considered for an imaging procedure,
patients with high pretest probability will be considered for an imaging procedure.

Patients with "low or moderate" pretest probability and a negative D-Dimer result will be followed for 3 months to evaluate potential development of deep venous thrombosis and/or pulmonary embolism.

These patients will be contacted by phone 3 month after their first visit.

Study Design

Study Type:

Observational

Actual Enrollment :

2040 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

STA®-Liatest®D-Di-Exclusion of Venous Thromboembolism

Study Start Date :

Nov 1, 2011

Actual Primary Completion Date :

Mar 1, 2016

Actual Study Completion Date :

Apr 1, 2016

Outcome Measures

Primary Outcome Measures

To demonstrate the ability of STA Liatest DDi combined with a clinical pretest probability (PTP) to safely exclude pulmonary embolism or deep venous thrombosis in a 3 month follow-up [at 3 months]
Occurence of pulmonary embolism or deep venous thrombosis during the 3 month follow-up after negative diagnosis (i.e. patients with PTP low/moderate and negative STA Liatest D-Di test)

Secondary Outcome Measures

1. To analyse results homogeneity (inter-centers) in the group "positive D-dimer result and negative diagnosis" (descriptive statistics only). 2. To determine prevalence of VTE in PTP high patients based on imaging results [at 3 months]
1. Prevalence of VTE in PTP high patients based on imaging results.

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 presenting 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 (or verbal no-opposition, as allowed by local regulations)
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,
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 post-partum 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 treatment) starting twenty four (24) hours or more before the D-dimer is measured
Previous anticoagulant therapy stopped less than three (3) months before the D-dimer is measured
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 enrollment 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern Medical Center	Chicago	Illinois	United States	60611
2	Indiana University Health	Indianapolis	Indiana	United States	46202
3	University of Iowa	Iowa City	Iowa	United States	52242
4	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
5	Brigham and Woman's Hosp	Boston	Massachusetts	United States	02115
6	Moses Cone Memorial Hospital	Greensboro	North Carolina	United States	27401
7	Univeristy Medical Center	Colombus	Ohio	United States	43210
8	Oklahoma Health Sciences Center	Oklahoma City	Oklahoma	United States	73104
9	Lehigh Valley Hospital Health Network	Allentown	Pennsylvania	United States	18103
10	Medical Center of South Carolina	Charleston	South Carolina	United States	29403
11	Texas Health Fort Worth Hospital	Fort Worth	Texas	United States	76104
12	Maisonneuve Rosemont Hospital	Montréal		Canada
13	University Hospital	Dijon		France
14	University Hospital	Grenoble		France	38043
15	University Hospital	Bologna		Italy
16	IRCCS H San Raffaele	Milan		Italy
17	University Hospital	Alicante		Spain
18	General Hospital	Soria		Spain