NCT04269603

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 17, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

November 3, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2021

Completed
Last Updated

February 14, 2022

Status Verified

January 1, 2022

Enrollment Period

2 months

First QC Date

December 23, 2019

Last Update Submit

February 11, 2022

Conditions

Healthy Volunteer

Keywords

light transmission aggregometryplateletsplatelet functionsvon Willebrand diseasequality assessment

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (8)

  • LTA intra assay variability

    Month 0

  • LTA intra assay variability

    Month 3

  • LTA intra assay variability

    Month 6

  • LTA inter operator variability

    Month 0

  • LTA inter operator variability

    Month 3

  • +3 more secondary outcomes

Study Arms (1)

30 healthy adult volunteers

OTHER

Healthy adult volunteers without hemorrhagic diathesis.

Device: Take blood (TA-8V (Stago®)

Interventions

Take blood (TA-8V (Stago®)DEVICE

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

30 healthy adult volunteers

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Haemostasis Unit/Haematology Laboratory, Groupement Hospitalier Est

Bron, 69677, France

Location

MeSH Terms

Conditions

von Willebrand Diseases

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersBlood Platelet DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2019

First Posted

February 17, 2020

Study Start

November 3, 2020

Primary Completion

January 6, 2021

Study Completion

January 6, 2021

Last Updated

February 14, 2022

Record last verified: 2022-01

Locations

FR(1)