NCT01221805

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,040 (actual)
• Sponsor: Diagnostica Stago · Industry
• Sex: All
• Age: 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Deep Venous Thrombosis
• Pulmonary Embolism
• D-dimer

Timeline

• Start date: 2011-11-01
• Primary completion: 2016-03-01
• Completion: 2016-04-01
• First posted: 2010-10-15
• Last updated: 2016-08-05

Locations

18 sites across 5 countries: United States, Canada, France, Italy, Spain