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

Not Applicable

Completed

• Conditions: Healthy Volunteer
• Interventions: Device: Take blood (TA-8V (Stago®)

• Registration Number: NCT04269603
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-23
• Study First Submitted QC: 2020-02-13
• Study First Posted: 2020-02-17
• Study Start: 2020-11-03
• Primary Completion: 2021-01-06
• Study Completion: 2021-01-06
• Status Verified: 2022-01
• Last Update Submitted: 2022-02-11
• Last Update Posted: 2022-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
30 healthy adult volunteers	Take blood (TA-8V (Stago®)	Healthy adult volunteers without hemorrhagic diathesis.

Primary Outcome Measures

Name	Time	Method
Platelets aggregation results for LTA on TA-8V (Stago®)	Month 6	Normal values for platelets aggregation will be established using various agonists to activate platelets. : * Epinephrine (STAGO®); * PMA (phorbol 12-myristate 13 acetate) (SIGMA®); * PAF (Platelet Activator Factor) (BACHEM®); * Ionophore calcium (SIGMA®); * 11-Epoxy (SIGMA®); * Prostaglandin E1 (SIGMA®)

Secondary Outcome Measures

Name	Time	Method
LTA inter operator variability	Month 6	Inter operator variability of maximal platelet aggregation will be assessed by percentage of agreement (%).
LTA intra assay variability	Month 6	Intra assay variability of maximal platelet aggregation will be assessed by calculating a coefficient of variation of the studied parameters.
Agonist reagents stability duration	up to 2 months post reagents reconstitution	Reagents will be reconstituted and stored at -20°C. They will be used for aggregation assay extemporaneously, 1 week, 2 weeks , 1 month and 2 months post reconstitution.

Trial Locations

Locations (1)

Clinical Haemostasis Unit/Haematology Laboratory, Groupement Hospitalier Est; 🇫🇷 Bron, France