Comparison of Two D-Dimers Dosing Techniques (COMPADDI)

June 4, 2021 updated by: University Hospital, Brest

Comparison of Two D-Dimers Dosing Techniques : LIATEST DDI PLUS (STAGO) Versus VIDAS D-DIMERS (BIOMERIEUX)

Study of the possibility of substitution of the automated STAGO D-Dimers method with the semi-automated VIDAS method, which is more expensive, longer to implement and requires the use of a dedicated automaton.

Study Overview

Status

Completed

Conditions

Detailed Description

To compare D-Dimer assay techniques in the exclusion of VTE (Thromboembolic Venous Disease):• BIOMERIEUX: D-Dimers VIDAS (considered as reference technique)• STAGO: D-Di PlusOn a population of patients recruited in Brest for a period of 1 year: patients for whom a dosage of VIDAS D-dimers is prescribed (approximately 3700 patients)

Study Type

Observational

Enrollment (Actual)

3027

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Brest, France, 29609
        • CHRU de Brest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient population recruited in Brest for a period of 1 year: patients for whom a dose of VIDAS D-dimers is prescribed (approximately 3700 patients)

Description

Inclusion Criteria:

  • Patients for whom a dosage of D-Dimers VIDAS is prescribed in the context of a suspicion of VTE at Brest CHRU.
  • No opposition formulated.

Exclusion Criteria:

  • Curative dose anticoagulant treatment whatever the indication,
  • Pregnancy in progress,
  • Follow-up at 3 months not possible,
  • Patient refusing to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
D-Dimers patients
population recruited in Brest for a period of 1 year: patients for whom a dose of VIDAS D-dimers is prescribed (approximately 3700 patients)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomerieux D-Dimer level
Time Frame: at the inclusion
quantification of Biomerieux D-Dimer level (VIDAS)
at the inclusion
Stago D-Dimer level
Time Frame: at the inclusion
quantification of Biomerieux D-Dimer level (STAGO)
at the inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2019

Primary Completion (Actual)

July 1, 2020

Study Completion (Actual)

January 1, 2021

Study Registration Dates

First Submitted

May 31, 2019

First Submitted That Met QC Criteria

May 31, 2019

First Posted (Actual)

June 4, 2019

Study Record Updates

Last Update Posted (Actual)

June 7, 2021

Last Update Submitted That Met QC Criteria

June 4, 2021

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 29BRC19.0034

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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