Clinical trial NCT04269603: LTA Assessement Using Aggregometer TA-8V (Stago®)
Official title: Normal Values and Quality Assessment of Light Transmission Aggregometry (LTA) Using Aggregometer TA-8V (Stago®)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteer
Keywords: light transmission aggregometry
platelets
platelet functions
von Willebrand disease
quality assessment
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Platelets aggregation results for LTA on TA-8V (Stago®)
timeFrame: Month 0
measure: Platelets aggregation results for LTA on TA-8V (Stago®)
timeFrame: Month 3
measure: Platelets aggregation results for LTA on TA-8V (Stago®)
timeFrame: Month 6
Secondary outcomes:
measure: LTA intra assay variability
timeFrame: Month 0
measure: LTA intra assay variability
timeFrame: Month 3
measure: LTA intra assay variability
timeFrame: Month 6
measure: LTA inter operator variability
timeFrame: Month 0
measure: LTA inter operator variability
timeFrame: Month 3
measure: LTA inter operator variability
timeFrame: Month 6
measure: Agonist reagents stability duration
timeFrame: up to 2 months post reagents reconstitution and 2 months post reconstitution with the same technician, the same automaton and the same healthy volunteer sample.
measure: Agonist reagents stability duration
timeFrame: up to 2 months post reagents reconstitution
Other outcomes:
Locations:
city: Bron
country: France
facility: Clinical Haemostasis Unit/Haematology Laboratory, Groupement Hospitalier Est
Study officials:
References: