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Completed

NCT Number: NCT04269603

LTA Assessement 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.

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Key information

Conditions

Healthy Volunteer Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Blood Platelet Disorders Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders von Willebrand Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Haemostasis Unit/Haematology Laboratory, Groupement Hospitalier Est

Bron, 69677, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Take blood (TA-8V (Stago®)

Device

Healthy volunteers will have 3 blood samples at M0, M3 and M6.

Primary outcomes

  1. Platelets aggregation results for LTA on TA-8V (Stago®)

    Time frame: Month 0

    Normal values for platelets aggregation will be established using various agonists to activate platelets. :

    • Ristocetin (STAGO®)

  2. Platelets aggregation results for LTA on TA-8V (Stago®)

    Time frame: Month 3

    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®)

  3. Platelets aggregation results for LTA on TA-8V (Stago®)

    Time frame: 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 outcomes

  1. LTA intra assay variability

    Time frame: Month 0

    Intra assay variability of maximal platelet aggregation will be assessed by calculating a coefficient of variation of the studied parameters.

  2. LTA intra assay variability

    Time frame: Month 3

    Intra assay variability of maximal platelet aggregation will be assessed by calculating a coefficient of variation of the studied parameters.

  3. LTA intra assay variability

    Time frame: Month 6

    Intra assay variability of maximal platelet aggregation will be assessed by calculating a coefficient of variation of the studied parameters.

  4. LTA inter operator variability

    Time frame: Month 0

    Inter operator variability of maximal platelet aggregation will be assessed by percentage of agreement (%).

  5. LTA inter operator variability

    Time frame: Month 3

    Inter operator variability of maximal platelet aggregation will be assessed by percentage of agreement (%).

  6. LTA inter operator variability

    Time frame: Month 6

    Inter operator variability of maximal platelet aggregation will be assessed by percentage of agreement (%).

  7. Agonist reagents stability duration

    Time frame: 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.

    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.

  8. Agonist reagents stability duration

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: NORMAGREG

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 17, 2020
Registry last updated
Feb 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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