Status:
NOT_YET_RECRUITING
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
Lead Sponsor:
University Hospital, Clermont-Ferrand
Conditions:
Direct Oral Anticoagulant
Hemmorhage
Eligibility:
All Genders
70+ years
Phase:
NA
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 mus...
Eligibility Criteria
Inclusion
- 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
- 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.)
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT07173075
Start Date
October 1 2025
End Date
October 1 2027
Last Update
September 15 2025
Active Locations (1)
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1
CHU de Clermont-Ferrand
Clermont-Ferrand, France, 63000