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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age70+
SponsorUniversity Hospital, Clermont-Ferrand

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: Case (patient with hemorrhagic event)Other 1 intervention
Group B: Control (patient without hemorrhagic event)Other 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

confirmed sarcopenia

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

Time frame
from enrollment and within a limit of 7 days after inclusion.
2

malnutrition

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.

Time frame
from enrollment and within a limit of 7 days after inclusion.
3

severe malnutrition

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.

Time frame
from enrollment and within a limit of 7 days after inclusion.
4

severity of muscle mass reduction

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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: