LTA Assessement Using Aggregometer TA-8V (Stago®) (NORMAGREG)

Civil Hospices of Lyon

Status: Completed

Conditions: Healthy Volunteer

Treatments: Device: Take blood (TA-8V (Stago®)

Study type: Interventional

Funder types: Other

Identifiers

NCT04269603

69HCL19_0661

Details and patient eligibility

About

Exploring platelet functions requires aggregation tests platelet. The Haematology Laboratory of Hospices Civils de Lyon currently has two new TA-8V plate aggregation automatons® (Stago).

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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female adults aged between 18 and 70 years
• Weighting more than 50 kg
• Subjects having signed informed consent
• Subjects registered in the French health-care system database

Exclusion criteria

• Personal history of anemia, thrombopenia, hemorrhagic disease
• 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

30 healthy adult volunteers

Other group

Description:

Healthy adult volunteers without hemorrhagic diathesis.

Treatment:

Device: Take blood (TA-8V (Stago®)