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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-31

Study Completion Date

2027-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Direct Oral Anticoagulant Hemmorhage Elderly Muscle Mass Sarcopenia Denutrition

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Case (patient with hemorrhagic event)

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.

Group Type OTHER

impedancemetry

Intervention Type 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

Control (patient without hemorrhagic event)

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.

Group Type OTHER

impedancemetry

Intervention Type 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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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bio-impedancemetry

Eligibility Criteria

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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.)

Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No