Direct Oral AnticoagulantSARCORRHAGEDNCT07173075
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
A study testing impedancemetry in people with Direct Oral Anticoagulant and Hemmorhage, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Direct Oral Anticoagulant, Hemmorhage, Elderly
- What is being tested?
- impedancemetry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2025to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
Lise laclautre, +334754963, promo_interne_drci@chu-clermontferrand.fr
Julien Soret
About this study
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).
Read more
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
- Being tested
- impedancemetry
- Keywords
- direct oral anticoagulant, hemmorhage, bleeding, elderly, muscle mass, sarcopenia, denutrition, impedancemetry
- Medical subject headings
- Sarcopenia, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
impedancemetryDiagnostic test
Also called bio-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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: impedancemetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from enrollment and within a limit of 7 days after inclusion.
Secondary outcomes (4)
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
Measured: from enrollment and within a limit of 7 days after inclusion.
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.
Measured: from enrollment and within a limit of 7 days after inclusion.
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.
Measured: from enrollment and within a limit of 7 days after inclusion.
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.
Measured: from enrollment and within a limit of 7 days after inclusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study startOct 2025 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Direct Oral AnticoagulantStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- julien Soret, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07173075
- Sponsor's protocol ID
- RBHP 2025 SORET
- Other IDs
- 2025-A01074-45
- Acronym
- SARCORRHAGED
- Status last verified
- Aug 2025
- First submitted
- 8 Sep 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07173075
- Acronym / sponsor ID
- SARCORRHAGED / RBHP 2025 SORET
- Conditions
- Direct Oral Anticoagulant, Hemmorhage, Elderly, Muscle Mass, Sarcopenia, Denutrition
- Keywords
- direct oral anticoagulant, hemmorhage, bleeding, elderly, muscle mass, sarcopenia, denutrition, impedancemetry
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 15 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case (patient with hemorrhagic event) | Other | Diagnostic Test: impedancemetryPatients 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. |
| Control (patient without hemorrhagic event) | Other | Diagnostic Test: impedancemetryPatients 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. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| impedancemetryAlso: bio-impedancemetryimpedancemetry by the InBody S10 device, during a visit, after stabilization of the patient's blood volume, within a limit of 7 days after inclusion | Diagnostic test | Case (patient with hemorrhagic event), Control (patient without hemorrhagic event) |
Primary outcome
Muscle mass
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.
4 secondary outcomes
confirmed sarcopenia
Time frame: from enrollment and within a limit of 7 days after inclusion.
malnutrition
Time frame: from enrollment and within a limit of 7 days after inclusion.
severe malnutrition
Time frame: from enrollment and within a limit of 7 days after inclusion.
severity of muscle mass reduction
Time frame: from enrollment and within a limit of 7 days after inclusion.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
julien Soret principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing impedancemetry in people with Direct Oral Anticoagulant and Hemmorhage, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise laclautre (+33473754963, promo_nterne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle mass (time frame: from enrollment and within a limit of 7 days after inclusion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.