CHU de Clermont-Ferrand
Clermont-Ferrand, 63000, France
NCT Number: NCT07173075
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.
Trial opening soon.
Get Notified70 year and older
All sexes
Interventional
Not applicable
Clermont-Ferrand, 63000, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Other names: bio-impedancemetry
Time frame: from enrollment and within a limit of 7 days after inclusion.
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.
This is the combination of:
Time frame: from enrollment and within a limit of 7 days after inclusion.
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):
The etiological criteria are as follows (one criterion is sufficient):
Time frame: from enrollment and within a limit of 7 days after inclusion.
According to the High Authority of Health, the criteria for severe malnutrition are as follows (one criterion is sufficient):
Time frame: from enrollment and within a limit of 7 days after inclusion.
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.
Contact information is provided by the study sponsor or research team.
University Hospital, Clermont-Ferrand
Other
Acronym: SARCORRHAGED
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