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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A01074-45 | Other Identifier | ANSM |
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This study aims to assess whether reduced muscle mass is associated with an increased risk of bleeding in the elderly receiving direct oral anticoagulant therapy.
The researchers will compare the muscle mass of patients who experienced a hemorrhage (case) with that of patients who did not (control).
Muscle mass is a key criterion in the assessment of sarcopenia and malnutrition, two conditions frequently associated with aging. Sarcopenia is characterized by a significant loss of muscle mass and strength, while malnutrition is an alteration of nutritional status, often accompanied by sarcopenia, weight loss or a low body mass index (BMI). So at the same time, we want to compare sarcopenia and malnutrition between the two groups (case and control).
Cases and controls will benefit from a consultation during which measurements will be taken: weight, height, BMI, calf circumference, impedancemetry, etc. A blood test will be taken to measure anti-Xa activity (drug activity) and any missing analyses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Case (patient with hemorrhagic event) | Other | Patients over 70 years old, treated with one of the two factor Xa inhibitors used in France (Apixaban, Rivaroxaban), who experienced a hemorrhagic event leading to hospitalization. |
|
| Control (patient without hemorrhagic event) | Other | Patients over 70 years old, treated with one of the two factor Xa inhibitors used in France (Apixaban, Rivaroxaban), followed in consultation or admitted to the hospitalization department, free from hemorrhagic events. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| impedancemetry | Diagnostic Test | impedancemetry by the InBody S10 device, during a visit, after stabilization of the patient's blood volume, within a limit of 7 days after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle mass | Appendicular muscle mass expressed in kg is measured by an InBody S10 impedance meter (Appendix 3: InBody S10 impedance meter), during a visit, after stabilization of the patient's blood volume, within a limit of 7 days after inclusion. | from enrollment and within a limit of 7 days after inclusion. |
| Measure | Description | Time Frame |
|---|---|---|
| confirmed sarcopenia | This is the combination of:
| from enrollment and within a limit of 7 days after inclusion. |
| malnutrition |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lise laclautre | Contact | +33473754963 | promo_nterne_drci@chu-clermontferrand.fr |
| Name | Affiliation | Role |
|---|---|---|
| julien Soret | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Clermont-Ferrand | Clermont-Ferrand | 63000 | France |
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According to the High Authority of Health, the diagnosis of malnutrition requires the presence of at least one phenotypic criterion and one etiological criterion. The phenotypic criteria are as follows (one criterion is sufficient):
The etiological criteria are as follows (one criterion is sufficient):
|
| from enrollment and within a limit of 7 days after inclusion. |
| severe malnutrition | According to the High Authority of Health, the criteria for severe malnutrition are as follows (one criterion is sufficient):
| from enrollment and within a limit of 7 days after inclusion. |
| severity of muscle mass reduction | There is no definition expressing a threshold; we will consider that the lower the variation is from the median, the greater the loss of muscle mass. | from enrollment and within a limit of 7 days after inclusion. |
| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D010335 | Pathologic Processes |
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