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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Muscle mass
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.)
研究组 & 干预措施
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.
干预措施: impedancemetry (Diagnostic Test)
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.
干预措施: impedancemetry (Diagnostic Test)
结局指标
主要结局
Muscle mass
时间窗: 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.
次要结局
- confirmed sarcopenia(from enrollment and within a limit of 7 days after inclusion.)
- malnutrition(from enrollment and within a limit of 7 days after inclusion.)
- severe malnutrition(from enrollment and within a limit of 7 days after inclusion.)
- severity of muscle mass reduction(from enrollment and within a limit of 7 days after inclusion.)