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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02523937
Date of registration: 13/08/2015
Prospective Registration: Yes
Primary sponsor: Diagnostica Stago R&D
Public title: Evaluation of Soluble Fibrin in Thrombosis Exclusion FSET
Scientific title: Evaluation of Performances of Soluble Fibrin Assay in Exclusion of Pulmonary Embolism and Deep Venous Thrombosis
Date of first enrolment: September 2015
Target sample size: 863
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02523937
Study type:  Observational
Study design:   
Phase: 
Countries of recruitment
France
Contacts
Name:     Geneviève Contant, PhD
Address: 
Telephone:
Email:
Affiliation:  Diagnostica Stago
Name:     Isabelle Mahe, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  Université of Paris 7 - Paris Diderot
Key inclusion & exclusion criteria

Inclusion Criteria:

- patients with non-opposition to participate in the evaluation,

- outpatients from Emergency or Internal Medicine Units,

- clinically suspected of PE or DVT.

Exclusion Criteria:

- patients under 18 years old,

- patients with opposition to participate in the evaluation,

- patients with contraindication to iodinated contrast media.



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Deep Vein Thrombosis (DVT)
Pulmonary Embolism (PE)
Intervention(s)
Other: Soluble Fibrin
Primary Outcome(s)
Performances of the Soluble Fibrin Assay for the exclusion of PE and DVT [Time Frame: 24 Months]
Secondary Outcome(s)
Threshold of the Soluble Fibrin assays for the exclusion of PE and DVT [Time Frame: 24 Months]
Secondary ID(s)
FSET 2014-A00588-39
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Hopital Lariboisière
Hôpital Louis Mourier
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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