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

Not Applicable

Not yet recruiting

• Conditions: Direct Oral Anticoagulant; Muscle Mass; Hemmorhage; Elderly; Sarcopenia; Denutrition

• Registration Number: NCT07173075
• Lead Sponsor: University Hospital, Clermont-Ferrand

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-09-08
• Study First Submitted QC: 2025-09-12
• Last Update Submitted: 2025-09-12
• Study First Posted: 2025-09-15
• Last Update Posted: 2025-09-15
• Study Start: 2025-10-01
• Primary Completion: 2026-10
• Study Completion: 2027-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 110

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

CHU de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France