NCT07173075

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Direct Oral Anticoagulant
• Hemmorhage
• Elderly
• Muscle Mass
• Sarcopenia
• Denutrition

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-10-01
• Completion: 2027-10-01
• First posted: 2025-09-15
• Last updated: 2025-09-15

Locations

1 site across 1 country: France