Comparison of Two D-Dimers Dosing Techniques

Completed

• Conditions: Blood Coagulation Disorder

• Registration Number: NCT03972839
• Lead Sponsor: University Hospital, Brest

Brief 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.

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 Timeline

• Status Verified: 2019-03
• Study First Submitted: 2019-05-31
• Study First Submitted QC: 2019-05-31
• Study First Posted: 2019-06-04
• Study Start: 2019-07-01
• Primary Completion: 2020-07-01
• Study Completion: 2021-01-01
• Last Update Submitted: 2021-06-04
• Last Update Posted: 2021-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3027

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Biomerieux D-Dimer level	at the inclusion	quantification of Biomerieux D-Dimer level (VIDAS)
Stago D-Dimer level	at the inclusion	quantification of Biomerieux D-Dimer level (STAGO)

Trial Locations

Locations (1)

CHRU de Brest; 🇫🇷 Brest, France