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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Device: Take blood (TA-8V (Stago®)

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bron, France, 69677
    • Clinical Haemostasis Unit/Haematology Laboratory, Groupement Hospitalier Est

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 30 healthy adult volunteers; Healthy adult volunteers without hemorrhagic diathesis.	Device: Take blood (TA-8V (Stago®); Healthy volunteers will have 3 blood samples at M0, M3 and M6.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
LTA inter operator variability	Inter operator variability of maximal platelet aggregation will be assessed by percentage of agreement (%).	Month 0
LTA inter operator variability	Inter operator variability of maximal platelet aggregation will be assessed by percentage of agreement (%).	Month 3
LTA inter operator variability	Inter operator variability of maximal platelet aggregation will be assessed by percentage of agreement (%).	Month 6
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.
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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 3, 2020
• Primary Completion (ACTUAL): January 6, 2021
• Study Completion (ACTUAL): January 6, 2021

Study Registration Dates

• First Submitted: December 23, 2019
• First Submitted That Met QC Criteria: February 13, 2020
• First Posted (ACTUAL): February 17, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 14, 2022
• Last Update Submitted That Met QC Criteria: February 11, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: platelets; light transmission aggregometry; quality assessment; von Willebrand disease; platelet functions
• Other Study ID Numbers: 69HCL19_0661

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No