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NCT03972839 Clinical Trial

Comparison of Two D-Dimers Dosing Techniques

Blood Coagulation Disorder Clinical Trial

— COMPADDI  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03972839
Other study ID # 29BRC19.0034
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2019
Est. completion date January 1, 2021

Study information
Verified date March 2019
Source University Hospital, Brest
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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)

Recruitment information / eligibility
Status Completed
Enrollment 3027
Est. completion date January 1, 2021
Est. primary completion date July 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
France CHRU de Brest Brest

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Biomerieux D-Dimer level quantification of Biomerieux D-Dimer level (VIDAS) at the inclusion
Primary Stago D-Dimer level quantification of Biomerieux D-Dimer level (STAGO) at the inclusion
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