Blood Coagulation DisordersFASTNCT02856789
Determination of Fibrin Activity in Plasma on STA-R® Prototype
An observational study of Blood Coagulation Disorders and Thrombotic Disorders, run by Diagnostica Stago R&D at 1 site in France.
Trial summary
The purpose of the study is to give the proof of concept of the Fibrin structure assay on STA-R® prototype. It aims to identify the parameters which discriminate the pathologic from the normal population. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Coagulation Disorders, Thrombotic Disorders, Hemorrhagic Disorders
- What is being tested?
- Routine hemostasis tests, Fibrin structure (FS) and Thromboelastography (TEG)
- How many people
- 913 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2016to Mar 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volonteers from Centre de Transfusion des Armées (CTSA) and from Centre Principal d'Expertise Médicale du Personnel Navigant (CPEMPN). Percy hospital patients from at least: Emergency Unit (EU), Intensive Care Unit (ICU), Burnt Treatment Center (BTC), Hematology department.
Who may be able to join
- Patients and healthy volunteers with non-opposition to participate in the evaluation
- Healthy volunteers : from 18 years to 70 years
- Patients : minimum age limit 18 years - no maximum age limit
Who cannot join
- Healthy volonteers with ongoing treatment
- Healthy volonteers with abnormal hemostasis results
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital d'Instruction des armées Percy - Laboratoire d'Hématologie
Clamart, 92140
About this study
The purpose of the study is to give the proof of concept of the Fibrin structure assay on STA-R® prototype. It aims to identify the parameters which discriminate the pathologic from the normal population. Secondary objectives are to determine the precision of the assay, to record the Fibrin activity, comparatively with thromboelastography on TEG®, in a coagulation activation assay and in a coagulation-lysis assay.
Read the detailed description
Background. Fibers thickness of the fibrin clot plays an important role on the clot stability and its resistance to the fibrinolysis. The innovative concept, based on the relationship between light spectrum through the fibrin clot and its fiber nanostructure (C.Dassi et al, ISTH 15ABS-3593), thanks to a multi-wavelength STA-R® prototype, was simplified by using a coag-lysis assay (An international study on the feasibility of a standardized combined plasma clot turbidity and lysis assay: SSC communication ; Pieters et al. ; JTH 2018) Preliminary results suggest that this new automated FS method provides new data on clot analysis and could be a useful tool in clinical practice in the management of hemostasis disorders. This study is extended to begining of march 2019.
Main objective. This study aims to determine the precision, the normal range of the FS method in comparison with Thromboelastography on TEG® and discriminate patients from healthy volunteers (HV).
Recruitment. 200 healthy volunteers without any known coagulation troubles, enrolled during coagulation testing or blood donation.
50 hospitalized patients or patients from consultations, without ongoing treatment (particularly anticoagulant treatment), with a normal hemostasis screening (Prothombin Time, Activated Partial Prothombine Time and Fibrinogen Level).
650 hospitalized patients for any pathology known and able to induce a increase or a decrease of the fibrinogen level, mainly from trauma patients and enrolled during coagulation testing.
The study is conducted in compliance with French regulation after ethics approval.
FS Assays. The FS determinations on STA-R® prototype and those on TEG® will be realized with fresh plasmas and whole blood samples respectively at the Hôpital d'Instruction des armées Percy. The screening tests (PT, APTT, and Fibrinogen) on STA-R® Evolution and the measurement of FS on a second STA-R® prototype will be performed with frozen plasmas at STAGO laboratory.
Statistical analysis of results. A statistical analysis will determine the most relevant parameters in the discrimination of the pathologic population from the normal population, and the quality control precision. Then, statistical analysis will compare STA-R® prototype method to the TEG® method to point out the most populations discriminating method.
- Being tested
- Routine hemostasis tests, Fibrin structure (FS), Thromboelastography (TEG), Specialized hemostasis tests
- Keywords
- Fibrin structure, Coag-Lysis assay, Fibrin formation, Fibrinolysis, TEG 5000, TEG 6S, Coagulo-lytic balance, Normal range, Thromboelastography
- Medical subject headings
- Blood Coagulation Disorders, Hemorrhagic Disorders, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine hemostasis testsOther
Prothrombin Time (PT),Thrombin Time (TT), Activated Partial Thromboplastin Time (APTT), Fibrinogen, D-Dimers
Fibrin structure (FS)Other
FS will be determined on STA-R® prototype at Percy and at Stago
Thromboelastography (TEG)Other
Thromboelastography will be processed on TEG® at Percy
Specialized hemostasis testsOther
Coagulation factors
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers (HV) | HV without any known treatment, without any coagulation trouble and with normal hemostasis results.
FS and TEG will be processed to define the most relevant parameters for normal range and the correlation between both assays.
Tests performed on HV :
* Routine hemostasis tests
* Fibrin structure (FS)
* Thromboelastography (TEG)
* Specialized hemostasis tests Receives: Other: Routine hemostasis tests; Other: Fibrin structure (FS); Other: Thromboelastography (TEG); Other: Specialized hemostasis tests | |
| Patients without coagulation disorder | Hospitalized patients without coagulation disorder or abnormal hemostasis and hematological results and witout ongoing treatment (mainly anticoagulant treatment). FS and TEG will be processed to determine the most relevant parameters to discriminate patients from normal range and the correlation between assays.
Tests performed on patients :
* Routine hemostasis tests
* Fibrin structure (FS)
* Thromboelastography (TEG) Receives: Other: Routine hemostasis tests; Other: Fibrin structure (FS); Other: Thromboelastography (TEG) | |
| Patients with coagulation disorders | Hospitalized patients with coagulation disorders, mainly trauma patients or abnormal hemostasis and hematological results, mainly decreased fibrinogen level . FS and TEG will be processed to determine the most relevant parameters to discriminate patients from normal range and the correlation between assays.
Tests performed on patients :
* Routine hemostasis tests
* Fibrin structure (FS)
* Thromboelastography (TEG) Receives: Other: Routine hemostasis tests; Other: Fibrin structure (FS); Other: Thromboelastography (TEG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic evolution of the number of protofibrils
Evolution of the Fibrin structure (FS) measurement will be performed on two plasma groups, the first group is constituted with fresh healthy volunteers and the second one with fresh patients. Coagulolytic balance will be measured with FS method. In addition, a normal range will be determined on fresh healthy volunteers without any known coagulation troubles. Fibrin structure is processed to determine the most relevant parameters to discriminate patients from normal range and the correlation between assays.
Measured: 12 months
Dynamic evolution of fibrin formation
Evolution of the optical density measurement and calculating the fibrinogen level and coagulolytic balance
Measured: 12 months
Secondary outcomes (6)
Thromboelastography measurement on TEG 5000
Thromboelastography will be performed on two plasma groups, the first group is constituted with fresh healthy volunteers and the second one with fresh patients. Viscoelastic clot parameters will be determined on TEG 5000. Thromboelastography is processed to determine the most relevant parameters to discriminate patients from normal range and the correlation between assays.
Measured: 12 months
Prothrombin Time (PT)
These assays will be performed at Stago on all samples from healthy volunteers (HV) and patients to allow the biological confirmation of normal samples from HV group. In case of one abnormal result, the sample is considered as not relevant for the normal range determination of Fibrin Structure measurement and will be discarded from HV group.
Measured: 12 months
Thrombin Time (TT)
These assays will be performed at Stago on all samples from healthy volunteers (HV) and patients to allow the biological confirmation of normal samples from HV group. In case of one abnormal result, the sample is considered as not relevant for the normal range determination of Fibrin Structure measurement and will be discarded from HV group.
Measured: 12 months
Activated Partial Thromboplastin Time (APTT)
These assays will be performed at Stago on all samples from healthy volunteers (HV) and patients to allow the biological confirmation of normal samples from HV group. In case of one abnormal result, the sample is considered as not relevant for the normal range determination of Fibrin Structure measurement and will be discarded from HV group.
Measured: 12 months
Fibrinogen
These assays will be performed at Stago on all samples from healthy volunteers (HV) and patients to allow the biological confirmation of normal samples from HV group. In case of one abnormal result, the sample is considered as not relevant for the normal range determination of Fibrin Structure measurement and will be discarded from HV group.
Measured: 12 months
D-Dimers
These assays will be performed at Stago on all samples from healthy volunteers (HV) and patients to allow the biological confirmation of normal samples from HV group. In case of one abnormal result, the sample is considered as not relevant for the normal range determination of Fibrin Structure measurement and will be discarded from HV group.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionMar 2019
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Blood Coagulation DisordersStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 913 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diagnostica Stago R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hôpital d'Instruction des armées Percy
- Responsible party
- Sponsor
- Investigators
- Vincent Foissaud, M D, Principal investigator, Hôpital d'Instruction des armées PercyGeneviève Contant, Ph D, Study director, Diagnostica Stago SAS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02856789
- Sponsor's protocol ID
- FAST STUDY 2016-A00869-42
- Acronym
- FAST
- Status last verified
- Aug 2020
- First submitted
- 8 Jul 2016
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Yeromonahos C, Polack B, Caton F. Nanostructure of the fibrin clot. Biophys J. 2010 Oct 6;99(7):2018-27. doi: 10.1016/j.bpj.2010.04.059.
PubMed 20923635Zabczyk M, Undas A. Plasma fibrin clot structure and thromboembolism: clinical implications. Pol Arch Intern Med. 2017 Dec 22;127(12):873-881. doi: 10.20452/pamw.4165. Epub 2017 Dec 11.
PubMed 29225327Pieters M, Philippou H, Undas A, de Lange Z, Rijken DC, Mutch NJ; Subcommittee on Factor XIII and Fibrinogen, and the Subcommittee on Fibrinolysis. An international study on the feasibility of a standardized combined plasma clot turbidity and lysis assay: communication from the SSC of the ISTH. J Thromb Haemost. 2018 May;16(5):1007-1012. doi: 10.1111/jth.14002. Epub 2018 Apr 15. No abstract available.
PubMed 29658191
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Fibrin Activity in Plasma on STA-R® Prototype
- ClinicalTrials.gov ID
- NCT02856789
- Acronym / sponsor ID
- FAST / FAST STUDY 2016-A00869-42
- Keywords
- Fibrin structure, Coag-Lysis assay, Fibrin formation, Fibrinolysis, TEG 5000, TEG 6S, Coagulo-lytic balance, Normal range
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 913 participants (actual)
- Lead sponsor
- Diagnostica Stago R&DIndustry (pharma, biotech, devices)
- Collaborators
- Hôpital d'Instruction des armées Percy
- Study start
- Aug 2016 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 5 Aug 2016 (estimated)
- 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 purpose of the study is to give the proof of concept of the Fibrin structure assay on STA-R® prototype. It aims to identify the parameters which discriminate the pathologic from the normal population. Secondary objectives are to determine the precision of the assay, to record the Fibrin activity, comparatively with thromboelastography on TEG®, in a coagulation activation assay and in a coagulation-lysis assay.
Detailed description
Background. Fibers thickness of the fibrin clot plays an important role on the clot stability and its resistance to the fibrinolysis. The innovative concept, based on the relationship between light spectrum through the fibrin clot and its fiber nanostructure (C.Dassi et al, ISTH 15ABS-3593), thanks to a multi-wavelength STA-R® prototype, was simplified by using a coag-lysis assay (An international study on the feasibility of a standardized combined plasma clot turbidity and lysis assay: SSC communication ; Pieters et al. ; JTH 2018) Preliminary results suggest that this new automated FS method provides new data on clot analysis and could be a useful tool in clinical practice in the management of hemostasis disorders. This study is extended to begining of march 2019.
Main objective. This study aims to determine the precision, the normal range of the FS method in comparison with Thromboelastography on TEG® and discriminate patients from healthy volunteers (HV).
Recruitment. 200 healthy volunteers without any known coagulation troubles, enrolled during coagulation testing or blood donation.
50 hospitalized patients or patients from consultations, without ongoing treatment (particularly anticoagulant treatment), with a normal hemostasis screening (Prothombin Time, Activated Partial Prothombine Time and Fibrinogen Level).
650 hospitalized patients for any pathology known and able to induce a increase or a decrease of the fibrinogen level, mainly from trauma patients and enrolled during coagulation testing.
The study is conducted in compliance with French regulation after ethics approval.
FS Assays. The FS determinations on STA-R® prototype and those on TEG® will be realized with fresh plasmas and whole blood samples respectively at the Hôpital d'Instruction des armées Percy. The screening tests (PT, APTT, and Fibrinogen) on STA-R® Evolution and the measurement of FS on a second STA-R® prototype will be performed with frozen plasmas at STAGO laboratory.
Statistical analysis of results. A statistical analysis will determine the most relevant parameters in the discrimination of the pathologic population from the normal population, and the quality control precision. Then, statistical analysis will compare STA-R® prototype method to the TEG® method to point out the most populations discriminating method.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers (HV) | – | Other: Routine hemostasis tests, Other: Fibrin structure (FS), Other: Thromboelastography (TEG), Other: Specialized hemostasis testsHV without any known treatment, without any coagulation trouble and with normal hemostasis results. FS and TEG will be processed to define the most relevant parameters for normal range and the correlation between both assays. Tests performed on HV : * Routine hemostasis tests * Fibrin structure (FS) * Thromboelastography (TEG) * Specialized hemostasis tests |
| Patients without coagulation disorder | – | Other: Routine hemostasis tests, Other: Fibrin structure (FS), Other: Thromboelastography (TEG)Hospitalized patients without coagulation disorder or abnormal hemostasis and hematological results and witout ongoing treatment (mainly anticoagulant treatment). FS and TEG will be processed to determine the most relevant parameters to discriminate patients from normal range and the correlation between assays. Tests performed on patients : * Routine hemostasis tests * Fibrin structure (FS) * Thromboelastography (TEG) |
| Patients with coagulation disorders | – | Other: Routine hemostasis tests, Other: Fibrin structure (FS), Other: Thromboelastography (TEG)Hospitalized patients with coagulation disorders, mainly trauma patients or abnormal hemostasis and hematological results, mainly decreased fibrinogen level . FS and TEG will be processed to determine the most relevant parameters to discriminate patients from normal range and the correlation between assays. Tests performed on patients : * Routine hemostasis tests * Fibrin structure (FS) * Thromboelastography (TEG) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volonteers from Centre de Transfusion des Armées (CTSA) and from Centre Principal d'Expertise Médicale du Personnel Navigant (CPEMPN). Percy hospital patients from at least: Emergency Unit (EU), Intensive Care Unit (ICU), Burnt Treatment Center (BTC), Hematology department.
Key inclusion criteria (3 listed)
- Patients and healthy volunteers with non-opposition to participate in the evaluation
- Healthy volunteers : from 18 years to 70 years
- Patients : minimum age limit 18 years - no maximum age limit
Key exclusion criteria (2 listed)
- Healthy volonteers with ongoing treatment
- Healthy volonteers with abnormal hemostasis results
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 |
|---|---|---|
| Routine hemostasis testsProthrombin Time (PT),Thrombin Time (TT), Activated Partial Thromboplastin Time (APTT), Fibrinogen, D-Dimers | Other | Healthy volunteers (HV), Patients with coagulation disorders, Patients without coagulation disorder |
| Fibrin structure (FS)FS will be determined on STA-R® prototype at Percy and at Stago | Other | Healthy volunteers (HV), Patients with coagulation disorders, Patients without coagulation disorder |
| Thromboelastography (TEG)Thromboelastography will be processed on TEG® at Percy | Other | Healthy volunteers (HV), Patients with coagulation disorders, Patients without coagulation disorder |
| Specialized hemostasis testsCoagulation factors | Other | Healthy volunteers (HV) |
Primary outcome
Dynamic evolution of the number of protofibrils
Time frame: 12 months
Evolution of the Fibrin structure (FS) measurement will be performed on two plasma groups, the first group is constituted with fresh healthy volunteers and the second one with fresh patients. Coagulolytic balance will be measured with FS method. In addition, a normal range will be determined on fresh healthy volunteers without any known coagulation troubles. Fibrin structure is processed to determine the most relevant parameters to discriminate patients from normal range and the correlation between assays.
Dynamic evolution of fibrin formation
Time frame: 12 months
Evolution of the optical density measurement and calculating the fibrinogen level and coagulolytic balance
6 secondary outcomes
Thromboelastography measurement on TEG 5000
Time frame: 12 months
Prothrombin Time (PT)
Time frame: 12 months
Thrombin Time (TT)
Time frame: 12 months
Activated Partial Thromboplastin Time (APTT)
Time frame: 12 months
Fibrinogen
Time frame: 12 months
D-Dimers
Time frame: 12 months
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 12 Aug 2020.
- Background: PubMed 20923635Yeromonahos C, Polack B, Caton F. Nanostructure of the fibrin clot. Biophys J. 2010 Oct 6;99(7):2018-27. doi: 10.1016/j.bpj.2010.04.059.
- Background: PubMed 29225327Zabczyk M, Undas A. Plasma fibrin clot structure and thromboembolism: clinical implications. Pol Arch Intern Med. 2017 Dec 22;127(12):873-881. doi: 10.20452/pamw.4165. Epub 2017 Dec 11.
- Background: PubMed 29658191Pieters M, Philippou H, Undas A, de Lange Z, Rijken DC, Mutch NJ; Subcommittee on Factor XIII and Fibrinogen, and the Subcommittee on Fibrinolysis. An international study on the feasibility of a standardized combined plasma clot turbidity and lysis assay: communication from the SSC of the ISTH. J Thromb Haemost. 2018 May;16(5):1007-1012. doi: 10.1111/jth.14002. Epub 2018 Apr 15. No abstract available.
- 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.
Vincent Foissaud, M D principal investigator
Hôpital d'Instruction des armées Percy
Geneviève Contant, Ph D study director
Diagnostica Stago SAS
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 Blood Coagulation Disorders and Thrombotic Disorders, run by Diagnostica Stago R&D 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 3 inclusion and 2 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 12 Aug 2020. 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?
Dynamic evolution of the number of protofibrils (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02856789, which also lists 3 linked publications.
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 12 Aug 2020.