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

Pulmonary Embolism Clinical Trial

Official title: STA®-Liatest®D-Di-Exclusion of Venous Thromboembolism

Status Completed

Clinical Trial 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.

Clinical Trial 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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• D-dimer
• Deep Venous Thrombosis
• Embolism
• Pulmonary Embolism
• Thromboembolism
• Thrombosis
• Venous Thromboembolism
• Venous Thrombosis

• NCT number: NCT01221805
• Study type: Observational
• Source: Diagnostica Stago
• Status: Completed
• Phase: Phase 4
• Start date: November 2011
• Completion date: April 2016