Anticoagulants and Bleeding DisordersBOANCT05026281
Bleeding Oral Anticoagulant Analyzer (BOA)
A study testing Quantra analyzer in people with Anticoagulants and Bleeding Disorders, run by University Hospital, Clermont-Ferrand at 6 sites in France.
Trial summary
The quality of the reversion of these serious hemorrhagic accidents under oral anticoagulants depends on the adequate use of reversion products but also on the speed of obtaining hemostasis data allowing to evaluate the effectiveness of this "chemical" hemostasis. . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anticoagulants and Bleeding Disorders
- What is being tested?
- Quantra analyzer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 6 sitesFrance
- Study dates
- 16 Dec 2021to 31 Jan 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient, male or female, treated long term with an oral anticoagulant (anti-vitamin K or direct), admitted to a hospital emergency department for intracerebral, digestive or intramuscular hemorrhage, defined as major according to the criteria of the International Society of Thrombosis and Haemostasis1. These three sites of bleeding are the most common.
- Capable of giving informed consent to participate in research or in the event of emergency care for a reference person.
- Affiliated with a Social Security scheme.
Who cannot join
- Incapable major.
- Administration within the last 24 hours of parenteral anticoagulant.
- Refusal of participation.
- Pregnant or breast feeding mother
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
University Hospital
Clermont-Ferrand, 63100
Grenoble University Hospital
Grenoble, 38043
Edouard Herriot University Hospital
Lyon, 69000
La Pitié-Salpétrière
Paris
Saint Etienne University Hospital
Saint-Etienne, 42055
Tours University Hospital
Tours, 37044
About this study
Official title: Intérêt de l'Utilisation du "Quantra® Haemostasis Analyser" Lors de la Prise en Charge Des Patients présentant Une hémorragie Grave Sous Anticoagulant Oral
The quality of the reversion of these serious hemorrhagic accidents under oral anticoagulants depends on the adequate use of reversion products but also on the speed of obtaining hemostasis data allowing to evaluate the effectiveness of this "chemical" hemostasis. .
Clot formation can be studied using different visco-elastic methodologies (thromboelastography or thromboelastometry) with a detectable change in clot formation with oral anticoagulants.
Read more
These techniques have been proven in patients who are often unstable and present with severe trauma with hemorrhagic shock, thus making it possible to guide the transfusion protocol. However, the level of recommendations in these patients, who are often polyhydrated and poly-transfused, is grade 1c due to small-scale studies with difficulty in analyzing the values of the visco-elasticity parameters in these patients. In addition, these methods are little used in current practice because of their difficult reading.
The use of visco-elastic methods in patients on oral anticoagulants has been little studied. However, taking an oral anticoagulant mainly causes coagulation disorders. The use of these methods would make it possible to assess the impact of the anticoagulant on hemostasis and to verify the correct reversion of hemostasis parameters. Quantra®, one of the visco-elastic methods, would make it possible to speed up the evaluation in the context of biology relocated to the patient's bed with a simplified reading of the factors involved in the formation of the clot in order to allow an immediate evaluation the quality of the reversion performed which may have an impact on the re-administration of reversion products or even an adaptation of the dose of reversion products according to the initial parameters at the time of severe bleeding before reversion. The objective of this pilot study is to study the metrological evolution, before and after reversion, of the hemostasis parameters evaluated by the Quantra® system from HemoSonics in a patient being his own control in the context of a severe hemorrhage occurring on oral anticoagulants (VKA or DOA).
Read the detailed description
This multicenter, prospective, cohort pilot study of physiopathology and physio-pharmacology, testing the added value of innovative functional exploration in addition to routine monitoring, in patients eligible for urgent reversion from anticoagulant therapy.
This study is part of the patient's routine care without modifying his management. In fact, eligible patients with severe bleeding under oral anticoagulant therapy will be treated according to departmental habits. The study will only consist of the addition of the analysis of a blood sample using the Quantra® before and after reversion without modification of the management.
All patients will be followed for the duration of hospitalization.
Primary objective :
The objective of this pilot study is to study the behavior of viscoelastic hemostasis parameters assessed by the Quantra® System in the context of severe bleeding occurring under oral anticoagulants (VKA or DOA).
Secondary objectives :
To study the effect of reversion of oral anticoagulants on hemostasis parameters assessed by the Quantra® system in the context of severe bleeding.
To study, in the context of severe bleeding, the relationship between the hemostasis parameters assessed by the Quantra® system and:
- conventional hemostasis parameters,
- the severity of the bleeding events before reversion, in the context of severe bleeding,
- recurrent bleeding or thrombotic events occurring during hospitalization.
The primary endpoint will be all of the Quantra® parameter values measured during the patient's therapeutic monitoring (before and after) without prioritization. The parameters of Quantra® are:
- CT: Clotting time (in seconds)
- CTH: Clotting time with Heparinase (in seconds)
- CTR: CT / CTH ratio clotting time
- CS: overall stiffness of the clot (hPa)
- PCS: Contribution of platelets to clot stiffness (hPa) FCS: Contribution of fibrinogen to clot stiffness (hPa)
Secondary endpoints:
- Classic coagulation tests: (TP / INR), TCA, Fibrinogen, FII, FV, FVII, FX
- Drug concentration (for DOA) by dilute thrombin time or specific anti-Xa activity
- Type and volume of filling solutes before reversion
- Assessment of blood loss (Hb, size of the hematoma)
- Clinical outcome of reversion: haemostatic efficacy rate at 24 hours, occurrence of haemorrhagic or thrombotic recurrences during hospitalization
- Duration of hospitalization
- Conditions
- Anticoagulants and Bleeding Disorders
- Being tested
- Quantra analyzer
- Keywords
- Haemorrhage, Anticoagulant, Emergency, Quantra analyzer
- Medical subject headings
- Hemostatic Disorders, Hemorrhage, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantra analyzerDevice
one additional tube will be collected during the usual blood test at two different time and analyzed by Quantra ®
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | at H0 and H0+30min = blood sample taken Receives: Device: Quantra analyzer |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in viscoelastic hemostasis parameters assessed by the Quantra® system in the context of severe bleeding occurring under oral anticoagulants (VKA or DOA)
Quantra® parameters were measured during the patient's therapeutic monitoring (before and after) without prioritization. The parameters of Quantra® are:
CT / CTH ratio clotting time overall stiffness of the clot (hPa) Contribution of platelets to clot stiffness (hPa) Contribution of fibrinogen to clot stiffness (hPa)
Measured: Hour 0 and Hour 0+30min
Change in viscoelastic hemostasis parameters assessed by the Quantra® system in the context of severe bleeding occurring under oral anticoagulants (VKA or DOA)
Quantra® parameters were measured during the patient's therapeutic monitoring (before and after) without prioritization. The parameters of Quantra® are:
CT : clotting time (in seconds) CTH clotting time with heparinase (in seconds)
Measured: Hour 0 and Hour 0+30min
Secondary outcomes (18)
Coagulation test
change in activated partial thromboplastin time (APTT) measures
Measured: Hour 0; Hour 0+30min; Hour 0+6 hours
Coagulation test
change in prothrombin time test values
Measured: Hour 0; Hour 0+30min; Hour 0+6 hours
Coagulation test
changes in levels of fibrinogen
Measured: Hour 0; Hour 0+30min; Hour 0+6 hours
Coagulation test
change in Factor II assay
Measured: Hour 0; Hour 0+30min; Hour 0+6 hours
Coagulation test
change in Factor V assay
Measured: Hour 0; Hour 0+30min; Hour 0+6 hours
Coagulation test
change in Factor VII assay
Measured: Hour 0; Hour 0+30min; Hour 0+6 hours
Coagulation test
change in Factor X assay
Measured: Hour 0; Hour 0+30min; Hour 0+6 hours
anti-factor Xa activity measurement
change in anti-factor Xa activity measurement
Measured: Hour 0; Hour 0+30min; Hour 0+6 hours
Type of filling solutes before reversion
Type of filling solutes before reversion
Measured: Hour 0
Volume of filling solutes before reversion
Volume of filling solutes before reversion
Measured: Hour 0
Evaluation of blood loss
haemoglobin concentration
Measured: Hour 0
Evaluation of blood loss
haematoma size
Measured: Hour 0
Clinical haemostasis evolution
haematoma volume
Measured: Hour 0+24
Clinical haemostasis evolution
Haematoma pain on numeric scale (0-10 points)
Measured: Hour 0+24
Clinical issue of reversion
efficacy haemostatic rate at 24 hours
Measured: Hour 0+24
Clinical issue of reversion
Recurrence of bleeding during hospitalization
Measured: Hour 0+24
Duration of hospitalization
how many days the patient is hospitalized
Measured: at the end of hospitalization
phone call
report of any adverse event occured in the month after the end of hospitalization
Measured: Month 0+1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start16 Dec 2021
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anticoagulants and Bleeding 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- H0 : blood analyse with Quantra® H0+30 min : blood analyse with Quantra® D0+30 : end of study
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Hôpital Edouard Herriot, University Hospital of Saint-Etienne, University Hospital, Grenoble, University Hospital, Tours, Pitié-Salpêtrière Hospital
- Responsible party
- Sponsor
- Investigators
- Dorian Teissandier, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05026281
- Sponsor's protocol ID
- AOI 2020 TEISSANDIER
- Other IDs
- 2020-A03240-39
- Acronym
- BOA
- Status last verified
- Sep 2022
- First submitted
- 13 Aug 2021
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intérêt de l'Utilisation du "Quantra® Haemostasis Analyser" Lors de la Prise en Charge Des Patients présentant Une hémorragie Grave Sous Anticoagulant Oral
- ClinicalTrials.gov ID
- NCT05026281
- Acronym / sponsor ID
- BOA / AOI 2020 TEISSANDIER
- Conditions
- Anticoagulants and Bleeding Disorders
- Keywords
- Haemorrhage, Anticoagulant, Emergency, Quantra analyzer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Hôpital Edouard Herriot, University Hospital of Saint-Etienne, University Hospital, Grenoble, University Hospital, Tours, Pitié-Salpêtrière Hospital
- Study start
- 16 Dec 2021 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 30 Aug 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 quality of the reversion of these serious hemorrhagic accidents under oral anticoagulants depends on the adequate use of reversion products but also on the speed of obtaining hemostasis data allowing to evaluate the effectiveness of this "chemical" hemostasis. .
Clot formation can be studied using different visco-elastic methodologies (thromboelastography or thromboelastometry) with a detectable change in clot formation with oral anticoagulants.
These techniques have been proven in patients who are often unstable and present with severe trauma with hemorrhagic shock, thus making it possible to guide the transfusion protocol. However, the level of recommendations in these patients, who are often polyhydrated and poly-transfused, is grade 1c due to small-scale studies with difficulty in analyzing the values of the visco-elasticity parameters in these patients. In addition, these methods are little used in current practice because of their difficult reading.
The use of visco-elastic methods in patients on oral anticoagulants has been little studied. However, taking an oral anticoagulant mainly causes coagulation disorders. The use of these methods would make it possible to assess the impact of the anticoagulant on hemostasis and to verify the correct reversion of hemostasis parameters. Quantra®, one of the visco-elastic methods, would make it possible to speed up the evaluation in the context of biology relocated to the patient's bed with a simplified reading of the factors involved in the formation of the clot in order to allow an immediate evaluation the quality of the reversion performed which may have an impact on the re-administration of reversion products or even an adaptation of the dose of reversion products according to the initial parameters at the time of severe bleeding before reversion. The objective of this pilot study is to study the metrological evolution, before and after reversion, of the hemostasis parameters evaluated by the Quantra® system from HemoSonics in a patient being his own control in the context of a severe hemorrhage occurring on oral anticoagulants (VKA or DOA).
Detailed description
This multicenter, prospective, cohort pilot study of physiopathology and physio-pharmacology, testing the added value of innovative functional exploration in addition to routine monitoring, in patients eligible for urgent reversion from anticoagulant therapy.
This study is part of the patient's routine care without modifying his management. In fact, eligible patients with severe bleeding under oral anticoagulant therapy will be treated according to departmental habits. The study will only consist of the addition of the analysis of a blood sample using the Quantra® before and after reversion without modification of the management.
All patients will be followed for the duration of hospitalization.
Primary objective :
The objective of this pilot study is to study the behavior of viscoelastic hemostasis parameters assessed by the Quantra® System in the context of severe bleeding occurring under oral anticoagulants (VKA or DOA).
Secondary objectives :
To study the effect of reversion of oral anticoagulants on hemostasis parameters assessed by the Quantra® system in the context of severe bleeding.
To study, in the context of severe bleeding, the relationship between the hemostasis parameters assessed by the Quantra® system and:
- conventional hemostasis parameters,
- the severity of the bleeding events before reversion, in the context of severe bleeding,
- recurrent bleeding or thrombotic events occurring during hospitalization.
The primary endpoint will be all of the Quantra® parameter values measured during the patient's therapeutic monitoring (before and after) without prioritization. The parameters of Quantra® are:
- CT: Clotting time (in seconds)
- CTH: Clotting time with Heparinase (in seconds)
- CTR: CT / CTH ratio clotting time
- CS: overall stiffness of the clot (hPa)
- PCS: Contribution of platelets to clot stiffness (hPa) FCS: Contribution of fibrinogen to clot stiffness (hPa)
Secondary endpoints:
- Classic coagulation tests: (TP / INR), TCA, Fibrinogen, FII, FV, FVII, FX
- Drug concentration (for DOA) by dilute thrombin time or specific anti-Xa activity
- Type and volume of filling solutes before reversion
- Assessment of blood loss (Hb, size of the hematoma)
- Clinical outcome of reversion: haemostatic efficacy rate at 24 hours, occurrence of haemorrhagic or thrombotic recurrences during hospitalization
- Duration of hospitalization
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- H0 : blood analyse with Quantra® H0+30 min : blood analyse with Quantra® D0+30 : end of study
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: Quantra analyzerat H0 and H0+30min = blood sample taken |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patient, male or female, treated long term with an oral anticoagulant (anti-vitamin K or direct), admitted to a hospital emergency department for intracerebral, digestive or intramuscular hemorrhage, defined as major according to the criteria of the International Society of Thrombosis and Haemostasis1. These three sites of bleeding are the most common.
- Capable of giving informed consent to participate in research or in the event of emergency care for a reference person.
- Affiliated with a Social Security scheme.
Key exclusion criteria (4 listed)
- Incapable major.
- Administration within the last 24 hours of parenteral anticoagulant.
- Refusal of participation.
- Pregnant or breast feeding mother
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 |
|---|---|---|
| Quantra analyzerone additional tube will be collected during the usual blood test at two different time and analyzed by Quantra ® | Device | Group 1 |
Primary outcome
change in viscoelastic hemostasis parameters assessed by the Quantra® system in the context of severe bleeding occurring under oral anticoagulants (VKA or DOA)
Time frame: Hour 0 and Hour 0+30min
Quantra® parameters were measured during the patient's therapeutic monitoring (before and after) without prioritization. The parameters of Quantra® are: CT / CTH ratio clotting time overall stiffness of the clot (hPa) Contribution of platelets to clot stiffness (hPa) Contribution of fibrinogen to clot stiffness (hPa)
Change in viscoelastic hemostasis parameters assessed by the Quantra® system in the context of severe bleeding occurring under oral anticoagulants (VKA or DOA)
Time frame: Hour 0 and Hour 0+30min
Quantra® parameters were measured during the patient's therapeutic monitoring (before and after) without prioritization. The parameters of Quantra® are: CT : clotting time (in seconds) CTH clotting time with heparinase (in seconds)
18 secondary outcomes
Coagulation test
Time frame: Hour 0; Hour 0+30min; Hour 0+6 hours
Coagulation test
Time frame: Hour 0; Hour 0+30min; Hour 0+6 hours
Coagulation test
Time frame: Hour 0; Hour 0+30min; Hour 0+6 hours
Coagulation test
Time frame: Hour 0; Hour 0+30min; Hour 0+6 hours
Coagulation test
Time frame: Hour 0; Hour 0+30min; Hour 0+6 hours
Coagulation test
Time frame: Hour 0; Hour 0+30min; Hour 0+6 hours
Coagulation test
Time frame: Hour 0; Hour 0+30min; Hour 0+6 hours
anti-factor Xa activity measurement
Time frame: Hour 0; Hour 0+30min; Hour 0+6 hours
Type of filling solutes before reversion
Time frame: Hour 0
Volume of filling solutes before reversion
Time frame: Hour 0
Evaluation of blood loss
Time frame: Hour 0
Evaluation of blood loss
Time frame: Hour 0
Clinical haemostasis evolution
Time frame: Hour 0+24
Clinical haemostasis evolution
Time frame: Hour 0+24
Clinical issue of reversion
Time frame: Hour 0+24
Clinical issue of reversion
Time frame: Hour 0+24
Duration of hospitalization
Time frame: at the end of hospitalization
phone call
Time frame: Month 0+1
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 7 Feb 2024.
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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.
Dorian Teissandier principal investigator
University Hospital, Clermont-Ferrand
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quantra analyzer in people with Anticoagulants and Bleeding Disorders, run by University Hospital, Clermont-Ferrand at 6 sites 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 4 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 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
change in viscoelastic hemostasis parameters assessed by the Quantra® system in the context of severe bleeding occurring under oral anticoagulants (VKA or DOA) (time frame: Hour 0 and Hour 0+30min). 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?
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 7 Feb 2024; AzTrials last refreshed its copy on 29 Oct 2026.