Healthy VolunteersNUAGENCT04842084
Normal Values of Parameters of Thrombin Generation in Function of Different Tissue Factor Concentrations
An observational study of Healthy Volunteers, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
The thrombin generation assay (TGA) is a good tool for measuring clot formation in plasma.TGA using Calibrated Automated Thrombography method, enables the quantification of thrombin concentrations in platelet-rich plasma (PRP) and in platelet-poor plasma (PPP).According to the clinical context, different TF(Tissue… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Blood samples
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- 23 Apr 2021to 30 Mar 2023
- Phase
- Observational
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy volunteers both sex aged between 18 and 50 without personal or family history of hemorrhage, thrombosis before 45 years old,
Who may be able to join
- Patient beneficiary or affiliated to Social security system
- Consent signed
Who cannot join
- Personal or family history (parents, brothers, sisters) of hemorrhage
- Personal or family history (parents, brothers, sisters) of thrombosis before 45 years old
- Taking an anti-inflammatory or an aspirin one week before the sampling
- Current take of an anticoagulant or antiaggregant treatment
- Surgery within previous month before the sampling
- Chronic pathology responsible of an inflammatory syndrome
Show all 9Show fewer
- Episode of viral or bacterial infections
- Known HIV or Hepatitis C Virus (HCV) infection
- Participation in a therapeutic clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of Normal Values of Parameters of Thrombin Generation in Fresh PRP and in PPP in Function of Different Tissue Factor Concentrations
The thrombin generation assay (TGA) is a good tool for measuring clot formation in plasma.TGA using Calibrated Automated Thrombography method, enables the quantification of thrombin concentrations in platelet-rich plasma (PRP) and in platelet-poor plasma (PPP).According to the clinical context, different TF(Tissue Factor) concentrations (1, 5 and 10 pM) can be used to trigger the coagulation cascade.The aim of the study is to determine the normal values of TG (Thrombin Generation) in fresh PRP and in PPP with different TF concentrations.
Read the detailed description
The thrombin generation assay (TGA) is a good tool for measuring clot formation in plasma. TGA using Calibrated Automated Thrombography method, enables the quantification of thrombin concentrations in platelet-rich plasma (PRP) and in platelet-poor plasma (PPP). The thrombin generation (TG) profile varies from patient to patient and depends on the activity of the pro and anti-coagulant factors. The TGA values depend on the analytical conditions such as Tissue Factor (TF) concentration and the plasma analyzed (PRP or PPP). According to the clinical context, different TF concentrations (1, 5 and 10 pM) can be used to trigger the coagulation cascade.
As a consequence, the reference values vary with the analytical conditions but also with the studied population (men or women). The reference values are not provided by the manufacturer and each laboratory has to establish the normal values according to the analytical conditions chosen for the pathology explored (hemorrhagic or thrombotic). Moreover, in PPP, the TG results can be different according to batch reagents. That is the reason why plasma will be frozen for a new determination in case of deviation of the result of the control plasma.
The aim of the study is to determine the normal values of TG in fresh PRP and in PPP with different TF concentrations.
- Conditions
- Healthy Volunteers
- Being tested
- Blood samples
- Keywords
- blood, plasma, blood platelets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesBiological
sampling of 10 S-Monovette tubes (Sarstedt) 4.3 ml of blood specifically for the study representing a total blood volume of 43 ml
| Study group | Role | What they receive |
|---|---|---|
| healthy volunteers | Healthy volunteers both sex aged between 18 and 50 without personal or family history of hemorrhage, thrombosis before 45 years old, Receives: Biological: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thrombin generation parameter in PRP (Peak : nmol thrombin)
Peak measurement
Measured: At inclusion
Thrombin generation parameter in PRP (ETP : nmol*min)
Endogenous Thrombin Potential measurement
Measured: At inclusion
Thrombin generation parameter in PRP (LT : min)
Lag Time measurement
Measured: At inclusion
Thrombin generation parameter in PRP (V : nmol/min)
Velocity index measurement
Measured: At inclusion
Thrombin generation parameter in PRP (TTP : min)
Time to Peak measurement
Measured: At inclusion
Thrombin generation parameter in PRP (ST : min)
Start Tail measurement
Measured: At inclusion
Secondary outcomes (6)
Thrombin generation parameters in PPP (Peak : nmol thrombin)
Peak measurement
Measured: At inclusion
Thrombin generation parameters in PPP (ETP : nmol*min)
Endogenous Thrombin Potential measurement
Measured: At inclusion
Thrombin generation parameters in PPP (LT: min)
Lag Time measurement
Measured: At inclusion
Thrombin generation parameters in PPP (V : nmol/min)
Velocity index measurement
Measured: At inclusion
Thrombin generation parameters in PPP (TTP : min)
Time to Peak measurement
Measured: At inclusion
Thrombin generation parameters in PPP (ST: min)
Start Tail measurement
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start23 Apr 2021
- Primary completion30 Mar 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brigitte Tardy, MD, Principal investigator, CHU de SAINT-ETIENNE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04842084
- Sponsor's protocol ID
- 20CH237
- Other IDs
- 2021-A00293-38
- Acronym
- NUAGE
- Status last verified
- Nov 2023
- First submitted
- 8 Apr 2021
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Normal Values of Parameters of Thrombin Generation in Fresh PRP and in PPP in Function of Different Tissue Factor Concentrations
- ClinicalTrials.gov ID
- NCT04842084
- Acronym / sponsor ID
- NUAGE / 20CH237
- Conditions
- Healthy Volunteers
- Keywords
- blood, plasma, blood platelets
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 23 Apr 2021 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 13 Apr 2021 (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.
The thrombin generation assay (TGA) is a good tool for measuring clot formation in plasma.TGA using Calibrated Automated Thrombography method, enables the quantification of thrombin concentrations in platelet-rich plasma (PRP) and in platelet-poor plasma (PPP).According to the clinical context, different TF(Tissue Factor) concentrations (1, 5 and 10 pM) can be used to trigger the coagulation cascade.The aim of the study is to determine the normal values of TG (Thrombin Generation) in fresh PRP and in PPP with different TF concentrations.
Detailed description
The thrombin generation assay (TGA) is a good tool for measuring clot formation in plasma. TGA using Calibrated Automated Thrombography method, enables the quantification of thrombin concentrations in platelet-rich plasma (PRP) and in platelet-poor plasma (PPP). The thrombin generation (TG) profile varies from patient to patient and depends on the activity of the pro and anti-coagulant factors. The TGA values depend on the analytical conditions such as Tissue Factor (TF) concentration and the plasma analyzed (PRP or PPP). According to the clinical context, different TF concentrations (1, 5 and 10 pM) can be used to trigger the coagulation cascade.
As a consequence, the reference values vary with the analytical conditions but also with the studied population (men or women). The reference values are not provided by the manufacturer and each laboratory has to establish the normal values according to the analytical conditions chosen for the pathology explored (hemorrhagic or thrombotic). Moreover, in PPP, the TG results can be different according to batch reagents. That is the reason why plasma will be frozen for a new determination in case of deviation of the result of the control plasma.
The aim of the study is to determine the normal values of TG in fresh PRP and in PPP with different TF concentrations.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthy volunteers | – | Biological: Blood samplesHealthy volunteers both sex aged between 18 and 50 without personal or family history of hemorrhage, thrombosis before 45 years old, |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy volunteers both sex aged between 18 and 50 without personal or family history of hemorrhage, thrombosis before 45 years old,
Key inclusion criteria (2 listed)
- Patient beneficiary or affiliated to Social security system
- Consent signed
Key exclusion criteria (9 listed)
- Personal or family history (parents, brothers, sisters) of hemorrhage
- Personal or family history (parents, brothers, sisters) of thrombosis before 45 years old
- Taking an anti-inflammatory or an aspirin one week before the sampling
- Current take of an anticoagulant or antiaggregant treatment
- Surgery within previous month before the 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 |
|---|---|---|
| Blood samplessampling of 10 S-Monovette tubes (Sarstedt) 4.3 ml of blood specifically for the study representing a total blood volume of 43 ml | Biological | healthy volunteers |
Primary outcome
Thrombin generation parameter in PRP (Peak : nmol thrombin)
Time frame: At inclusion
Peak measurement
Thrombin generation parameter in PRP (ETP : nmol*min)
Time frame: At inclusion
Endogenous Thrombin Potential measurement
Thrombin generation parameter in PRP (LT : min)
Time frame: At inclusion
Lag Time measurement
Thrombin generation parameter in PRP (V : nmol/min)
Time frame: At inclusion
Velocity index measurement
Thrombin generation parameter in PRP (TTP : min)
Time frame: At inclusion
Time to Peak measurement
Thrombin generation parameter in PRP (ST : min)
Time frame: At inclusion
Start Tail measurement
6 secondary outcomes
Thrombin generation parameters in PPP (Peak : nmol thrombin)
Time frame: At inclusion
Thrombin generation parameters in PPP (ETP : nmol*min)
Time frame: At inclusion
Thrombin generation parameters in PPP (LT: min)
Time frame: At inclusion
Thrombin generation parameters in PPP (V : nmol/min)
Time frame: At inclusion
Thrombin generation parameters in PPP (TTP : min)
Time frame: At inclusion
Thrombin generation parameters in PPP (ST: min)
Time frame: At inclusion
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 1 Dec 2023.
- Individual participant dataSharing planned: No
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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.
Brigitte Tardy, MD principal investigator
CHU de SAINT-ETIENNE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteers, run by Centre Hospitalier Universitaire de Saint Etienne 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 2 inclusion and 9 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 1 Dec 2023. 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?
Thrombin generation parameter in PRP (Peak : nmol thrombin) (time frame: At inclusion). The study lists 6 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 1 Dec 2023.