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

Healthy Volunteer Clinical Trial

— NORMAGREG  

Official title:

Normal Values and Quality Assessment of Light Transmission Aggregometry (LTA) Using Aggregometer TA-8V (Stago®)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04269603
• Other study ID #: 69HCL19_0661
• Status: Completed
• Phase: N/A
• Start date: November 3, 2020
• Est. completion date: January 6, 2021

Study information

• Verified date: January 2022
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: January 6, 2021
• Est. primary completion date: January 6, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Device:
• Take blood (TA-8V (Stago®)
Healthy volunteers will have 3 blood samples at M0, M3 and M6.

Locations

Country	Name	City	State
France	Clinical Haemostasis Unit/Haematology Laboratory, Groupement Hospitalier Est	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Platelets aggregation results for LTA on TA-8V (Stago®)	Normal values for platelets aggregation will be established using various agonists to activate platelets. : • Ristocetin (STAGO®)	Month 0
Primary	Platelets aggregation results for LTA on TA-8V (Stago®)	Normal values for platelets aggregation will be established using various agonists to activate platelets. : Collagen (STAGO®); ADP (adenosine diphosphate) (STAGO®); Arachidonate (STAGO®); TRAP (Thrombin Receptor Activating Platelet) (STAGO®)	Month 3
Primary	Platelets aggregation results for LTA on TA-8V (Stago®)	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®)	Month 6
Secondary	LTA intra assay variability	Intra assay variability of maximal platelet aggregation will be assessed by calculating a coefficient of variation of the studied parameters.	Month 0
Secondary	LTA intra assay variability	Intra assay variability of maximal platelet aggregation will be assessed by calculating a coefficient of variation of the studied parameters.	Month 3
Secondary	LTA intra assay variability	Intra assay variability of maximal platelet aggregation will be assessed by calculating a coefficient of variation of the studied parameters.	Month 6
Secondary	LTA inter operator variability	Inter operator variability of maximal platelet aggregation will be assessed by percentage of agreement (%).	Month 0
Secondary	LTA inter operator variability	Inter operator variability of maximal platelet aggregation will be assessed by percentage of agreement (%).	Month 3
Secondary	LTA inter operator variability	Inter operator variability of maximal platelet aggregation will be assessed by percentage of agreement (%).	Month 6
Secondary	Agonist reagents stability duration	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.	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.
Secondary	Agonist reagents stability duration	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.	up to 2 months post reagents reconstitution