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 (SARCORRHAGED)

University Hospital, Clermont-Ferrand

Status: Begins enrollment this month

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

Treatments: Diagnostic Test: impedancemetry

Study type: Interventional

Funder types: Other

Identifiers

NCT07173075

RBHP 2025 SORET

2025-A01074-45 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Case (patient with hemorrhagic event)

Other group

Description:

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.

Treatment:

Diagnostic Test: impedancemetry

Control (patient without hemorrhagic event)

Other group

Description:

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.

Treatment:

Diagnostic Test: impedancemetry