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
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Blood Coagulation Disorder
• Blood Coagulation Disorders
• Hemostatic Disorders

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