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

Completed

• Conditions: D-dimer; Deep Venous Thrombosis; Pulmonary Embolism

• Registration Number: NCT01221805
• Lead Sponsor: Diagnostica Stago

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.

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 Timeline

• Study First Submitted: 2010-10-12
• Study First Submitted QC: 2010-10-14
• Study First Posted: 2010-10-15
• Study Start: 2011-11
• Primary Completion: 2016-03
• Study Completion: 2016-04
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-04
• Last Update Posted: 2016-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2040

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (15)

Brigham and Woman's Hosp; 🇺🇸 Boston, Massachusetts, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Northwestern Medical Center; 🇺🇸 Chicago, Illinois, United States

Indiana University Health; 🇺🇸 Indianapolis, Indiana, United States

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

Moses Cone Memorial Hospital; 🇺🇸 Greensboro, North Carolina, United States

Univeristy Medical Center; 🇺🇸 Colombus, Ohio, United States

Lehigh Valley Hospital Health Network; 🇺🇸 Allentown, Pennsylvania, United States

Oklahoma Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States

Medical Center of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Maisonneuve Rosemont Hospital; 🇨🇦 Montréal, Canada

University Hospital; 🇪🇸 Alicante, Spain

IRCCS H San Raffaele; 🇮🇹 Milan, Italy

Texas Health Fort Worth Hospital; 🇺🇸 Fort Worth, Texas, United States

General Hospital; 🇪🇸 Soria, Spain