Denutrition, Direct Oral Anticoagulant, Elderly, Hemmorhage, Muscle Mass, Sarcopenia
Conditions
Keywords
direct oral anticoagulant, hemmorhage, bleeding, elderly, muscle mass, sarcopenia, denutrition, impedancemetry
Brief summary
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.
Interventions
DIAGNOSTIC_TESTimpedancemetry
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
Sponsors
University Hospital, Clermont-Ferrand
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age of at least 70 years * treated with one of the two factor Xa inhibitors used in France: Apixaban, Rivaroxaban. * For cases : hemorrhagic event causing hospitalization * For controls : free from hemorrhagic events.
Exclusion criteria
* Failure to obtain a consent form * Patient under legal protection (guardianship, curatorship, or legal safeguard) * Recurrent bleeding from a pre-existing lesion that has not received specific treatment. For example: unexplored gastrointestinal bleeding, cutaneous bleeding from a cancerous wound with therapeutic abstention. * Bleeding caused by high-velocity trauma, surgery, or assault * Contraindications to impedance measurement: pacemaker, cardiac defibrillator * Elements that may provide erroneous impedance measurement data: bilateral limb amputation, bilateral joint replacements, dialysis. * Unable to maintain the supine position. * Digestive absorption disorder (celiac disease, short bowel, stoma, etc.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Muscle mass | from enrollment and within a limit of 7 days after inclusion. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| confirmed sarcopenia | from enrollment and within a limit of 7 days after inclusion. | This is the combination of: * a reduction in muscle strength determined by a grip strength measurement and a Timed Chair Stand Test measurement * a reduction in muscle mass, determined by the primary endpoint |
| malnutrition | from enrollment and within a limit of 7 days after inclusion. | 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): * Weight loss ≥ 5% in 1 month or ≥ 10% in 6 months or ≥ 10% compared to usual weight before the onset of the disease; * BMI \< 22 kg/m²; * Confirmed sarcopenia The etiological criteria are as follows (one criterion is sufficient): * Reduction in food intake of ≥ 50% for more than 1 week, or any reduction in intake for more than 2 weeks compared to: usual food consumption or protein-energy requirements; * Reduced absorption (malabsorption/maldigestion); * Pathological situation (with or without inflammatory syndrome): acute pathology or chronic pathology or progressive malignant pathology. |
| severe malnutrition | from enrollment and within a limit of 7 days after inclusion. | According to the High Authority of Health, the criteria for severe malnutrition are as follows (one criterion is sufficient): * BMI \< 20 kg/m²; * Weight loss: ≥ 10% in 1 month, or ≥ 15% in 6 months, or ≥ 15% compared to the usual weight before the onset of the disease; * Albumin level ≤ 30 g/L. |
| severity of muscle mass reduction | from enrollment and within a limit of 7 days after inclusion. | 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. |
Countries
France
Contacts
Primary ContactLise laclautre
Outcome results
None listed