NCT03972839

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,027

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 4, 2019

Completed
27 days until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

June 7, 2021

Status Verified

March 1, 2019

Enrollment Period

1 year

First QC Date

May 31, 2019

Last Update Submit

June 4, 2021

Conditions

Blood Coagulation Disorder

Keywords

Blood CoagulationDDimers

Outcome Measures

Primary Outcomes (2)

  • Biomerieux D-Dimer level

    quantification of Biomerieux D-Dimer level (VIDAS)

    at the inclusion

  • Stago D-Dimer level

    quantification of Biomerieux D-Dimer level (STAGO)

    at the inclusion

Study Arms (1)

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)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Brest

Brest, 29609, France

Location

MeSH Terms

Conditions

Blood Coagulation DisordersThrombosis

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2019

First Posted

June 4, 2019

Study Start

July 1, 2019

Primary Completion

July 1, 2020

Study Completion

January 1, 2021

Last Updated

June 7, 2021

Record last verified: 2019-03

Locations

FR(1)