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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A03240-39 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| Hôpital Edouard Herriot | OTHER |
| University Hospital of Saint-Etienne | OTHER |
| University Hospital, Grenoble | OTHER |
| University Hospital, Tours |
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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).
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:
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:
Secondary endpoints:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | at H0 and H0+30min = blood sample taken |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quantra analyzer | Device | one additional tube will be collected during the usual blood test at two different time and analyzed by Quantra ® |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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) | Hour 0 and Hour 0+30min |
| Measure | Description | Time Frame |
|---|---|---|
| Coagulation test | change in activated partial thromboplastin time (APTT) measures | Hour 0; Hour 0+30min; Hour 0+6 hours |
| Coagulation test | change in prothrombin time test values |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dorian Teissandier | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Clermont-Ferrand | 63100 | France | |||
| Grenoble University Hospital |
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| ID | Term |
|---|---|
| D020141 | Hemostatic Disorders |
| D006470 | Hemorrhage |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006474 | Hemorrhagic Disorders |
| D006402 | Hematologic Diseases |
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| OTHER |
| Pitié-Salpêtrière Hospital | OTHER |
H0 : blood analyse with Quantra® H0+30 min : blood analyse with Quantra® D0+30 : end of study
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No masking
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| Hour 0; Hour 0+30min; Hour 0+6 hours |
| Coagulation test | changes in levels of fibrinogen | Hour 0; Hour 0+30min; Hour 0+6 hours |
| Coagulation test | change in Factor II assay | Hour 0; Hour 0+30min; Hour 0+6 hours |
| Coagulation test | change in Factor V assay | Hour 0; Hour 0+30min; Hour 0+6 hours |
| Coagulation test | change in Factor VII assay | Hour 0; Hour 0+30min; Hour 0+6 hours |
| Coagulation test | change in Factor X assay | Hour 0; Hour 0+30min; Hour 0+6 hours |
| anti-factor Xa activity measurement | change in anti-factor Xa activity measurement | Hour 0; Hour 0+30min; Hour 0+6 hours |
| Type of filling solutes before reversion | Type of filling solutes before reversion | Hour 0 |
| Volume of filling solutes before reversion | Volume of filling solutes before reversion | Hour 0 |
| Evaluation of blood loss | haemoglobin concentration | Hour 0 |
| Evaluation of blood loss | haematoma size | Hour 0 |
| Clinical haemostasis evolution | haematoma volume | Hour 0+24 |
| Clinical haemostasis evolution | Haematoma pain on numeric scale (0-10 points) | Hour 0+24 |
| Clinical issue of reversion | efficacy haemostatic rate at 24 hours | Hour 0+24 |
| Clinical issue of reversion | Recurrence of bleeding during hospitalization | Hour 0+24 |
| Duration of hospitalization | how many days the patient is hospitalized | at the end of hospitalization |
| phone call | report of any adverse event occured in the month after the end of hospitalization | Month 0+1 |
| Grenoble |
| 38043 |
| France |
| Edouard Herriot University Hospital | Lyon | 69000 | France |
| La Pitié-Salpétrière | Paris | France |
| Saint Etienne University Hospital | Saint-Etienne | 42055 | France |
| Tours University Hospital | Tours | 37044 | France |
| D006425 |
| Hemic and Lymphatic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |