Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
34 participants
INTERVENTIONAL
2020-11-03
2021-01-06
Brief Summary
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The supplier of these devices does not offer reference values for these tests. There are also no references in the data literature. Therefore reference values must be established from healthy volunteer subjects.
The use of these automatons is subject to the NF (French Standard) EN (European Standard) ISO (International Organization for Standardization) 15189 standard of the COFRAC ( French Accreditation Comity) that requires checking their proper functioning. This audit must be traced in a method validation folder.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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30 healthy adult volunteers
Healthy adult volunteers without hemorrhagic diathesis.
Take blood (TA-8V (Stago®)
Healthy volunteers will have 3 blood samples at M0, M3 and M6.
Interventions
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Take blood (TA-8V (Stago®)
Healthy volunteers will have 3 blood samples at M0, M3 and M6.
Eligibility Criteria
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Inclusion Criteria
* Weighting more than 50 kg
* Subjects having signed informed consent
* Subjects registered in the French health-care system database
Exclusion Criteria
* Caffeine intake 2 hours prior to blood sampling
* Tobacco intake in the half hour prior to blood sampling
* Use of any drug impacting platelet function
* for antiplatelet agents: at least 10 days prior to blood sampling
* for anti-depressants: at least 10 days prior to blood sampling
* for non-steroid anti-inflammatories: at least 3 days prior to blood sampling
* Refusal to undergo the 3 visits and 3 blood samples of the study
* Refusal to sign the informed consent form
* No registration in the French Health-care system database
* Pregnant women and women who are breastfeeding
18 Years
70 Years
ALL
Yes
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Locations
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Clinical Haemostasis Unit/Haematology Laboratory, Groupement Hospitalier Est
Bron, , France
Countries
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Other Identifiers
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69HCL19_0661
Identifier Type: -
Identifier Source: org_study_id
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