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Evaluation of Soluble Fibrin in Thrombosis Exclusion

NCT02523937 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 863

Last updated 2019-04-18

No results posted yet for this study

Summary

The purpose of the study is to evaluate the performances of Soluble Fibrin assay for exclusion of Pulmonary Embolism and Deep Venous Thrombosis. Secondary objectives are to determine the threshold value from the ROC curves, the possible interest in the positive diagnosis of Venous Thromboembolism (VTE), and to verify the absence of influence of age on the SF results.

Conditions

  • Pulmonary Embolism (PE)
  • Deep Vein Thrombosis (DVT)

Interventions

OTHER

Soluble Fibrin

Evaluating the diagnostic performances of the assay in terms of sensitivity, specificity, negative and positive predictive values; from calculation of the area under the curve in comparison with the D-dimers.

Sponsors & Collaborators

  • Hôpital Louis Mourier

    collaborator OTHER

  • Hopital Lariboisière

    collaborator OTHER

  • Diagnostica Stago R&D

    lead INDUSTRY

Principal Investigators

  • Isabelle Mahe, MD, PhD · Université of Paris 7 - Paris Diderot

  • Geneviève Contant, PhD · Diagnostica Stago

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2018-05-31
Completion
2018-07-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02523937 on ClinicalTrials.gov