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

NCT07173075 | Not Yet Recruiting

• 2 other identifiers: RBHP 2025 SORET2025-A01074-45
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

direct oral anticoagulant; hemmorhage; bleeding; elderly; muscle mass; sarcopenia; denutrition; impedancemetry

Outcome Measures

Primary Outcomes (1)

• Muscle mass

  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.

  from enrollment and within a limit of 7 days after inclusion.

Secondary Outcomes (4)

• confirmed sarcopenia

  from enrollment and within a limit of 7 days after inclusion.

• malnutrition

  from enrollment and within a limit of 7 days after inclusion.

• severe malnutrition

  from enrollment and within a limit of 7 days after inclusion.

• severity of muscle mass reduction

  from enrollment and within a limit of 7 days after inclusion.

Study Arms (2)

Case (patient with hemorrhagic event)

OTHER

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.

Diagnostic Test: impedancemetry

Control (patient without hemorrhagic event)

OTHER

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.

Diagnostic Test: impedancemetry

Interventions

impedancemetry DIAGNOSTIC_TEST

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

Also known as: bio-impedancemetry

Case (patient with hemorrhagic event); Control (patient without hemorrhagic event)

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

Sarcopenia; Hemorrhage

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pathologic Processes

Study Officials

• julien Soret

  CHU de Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise laclautre

CONTACT

+33473754963; promo_nterne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 15, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: September 15, 2025

Record last verified: 2025-08

Locations

FR (1)