Evaluation of the Relationship Between Muscle Mass Measured by Bioelectrical Impedance Analysis and the Risk of Hemorrhagic Events Under Direct Oral Anticoagulants in the Elderly
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: impedancemetry.
- Who it may be relevant to
- Registry conditions: Direct Oral Anticoagulant, Hemmorhage, Elderly, Muscle Mass. Basic parameters: from 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 test impedancemetry
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
Primary outcome measures
- Muscle mass [Time frame: from enrollment and within a limit of 7 days after inclusion.]
Secondary outcome measures (4)
- confirmed sarcopenia [Time frame: from enrollment and within a limit of 7 days after inclusion.]
- malnutrition [Time frame: from enrollment and within a limit of 7 days after inclusion.]
- severe malnutrition [Time frame: from enrollment and within a limit of 7 days after inclusion.]
- severity of muscle mass reduction [Time frame: from enrollment and within a limit of 7 days after inclusion.]
Eligibility criteria
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.)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Screening
Study locations
France · 1 center
- CHU de Clermont-Ferrand — Clermont-Ferrand
Identifiers
NCT: NCT07173075 · RBHP 2025 SORET · 2025-A01074-45