Healthy VolunteerNORMAGREGNCT04269603
LTA Assessement Using Aggregometer TA-8V (Stago®)
A study testing Take blood (TA-8V (Stago®) in people with Healthy Volunteer, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Take blood (TA-8V (Stago®)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 3 Nov 2020to 6 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Clinical Haemostasis Unit/Haematology Laboratory, Groupement Hospitalier Est
Bron, 69677
About this study
Official title: 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.
- Conditions
- Healthy Volunteer
- Being tested
- Take blood (TA-8V (Stago®)
- Keywords
- light transmission aggregometry, platelets, platelet functions, von Willebrand disease, quality assessment
- Medical subject headings
- von Willebrand Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Take blood (TA-8V (Stago®)Device
Healthy volunteers will have 3 blood samples at M0, M3 and M6.
| Study group | Role | What they receive |
|---|---|---|
| 30 healthy adult volunteers | Other | Healthy adult volunteers without hemorrhagic diathesis. Receives: Device: Take blood (TA-8V (Stago®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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®)
Measured: 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®)
Measured: 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®)
Measured: Month 6
Secondary outcomes (8)
LTA intra assay variability
Intra assay variability of maximal platelet aggregation will be assessed by calculating a coefficient of variation of the studied parameters.
Measured: 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.
Measured: 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.
Measured: Month 6
LTA inter operator variability
Inter operator variability of maximal platelet aggregation will be assessed by percentage of agreement (%).
Measured: Month 0
LTA inter operator variability
Inter operator variability of maximal platelet aggregation will be assessed by percentage of agreement (%).
Measured: Month 3
LTA inter operator variability
Inter operator variability of maximal platelet aggregation will be assessed by percentage of agreement (%).
Measured: 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.
Measured: 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.
Measured: up to 2 months post reagents reconstitution
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start3 Nov 2020
- Primary completion6 Jan 2021
- Study completion6 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04269603
- Sponsor's protocol ID
- 69HCL19_0661
- Acronym
- NORMAGREG
- Status last verified
- Jan 2022
- First submitted
- 23 Dec 2019
- Last updated
- 14 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normal Values and Quality Assessment of Light Transmission Aggregometry (LTA) Using Aggregometer TA-8V (Stago®)
- ClinicalTrials.gov ID
- NCT04269603
- Acronym / sponsor ID
- NORMAGREG / 69HCL19_0661
- Conditions
- Healthy Volunteer
- Keywords
- light transmission aggregometry, platelets, platelet functions, von Willebrand disease, quality assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 3 Nov 2020 (actual)
- Primary completion
- 6 Jan 2021 (actual)
- Study completion
- 6 Jan 2021 (actual)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 30 healthy adult volunteers | Other | Device: Take blood (TA-8V (Stago®)Healthy adult volunteers without hemorrhagic diathesis. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Take blood (TA-8V (Stago®)Healthy volunteers will have 3 blood samples at M0, M3 and M6. | Device | 30 healthy adult volunteers |
Primary outcome
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®)
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®)
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®)
8 secondary outcomes
LTA intra assay variability
Time frame: Month 0
LTA intra assay variability
Time frame: Month 3
LTA intra assay variability
Time frame: Month 6
LTA inter operator variability
Time frame: Month 0
LTA inter operator variability
Time frame: Month 3
LTA inter operator variability
Time frame: Month 6
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.
Agonist reagents stability duration
Time frame: up to 2 months post reagents reconstitution
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Take blood (TA-8V (Stago®) in people with Healthy Volunteer, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelets aggregation results for LTA on TA-8V (Stago®) (time frame: Month 0). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2022.