A Retrospective, Observational Study to Evaluate Hemoglobin Variability in Kidney Transplant Recipients With Chronic Renal Anemia.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 368
- 试验地点
- 22
- 主要终点
- The primary endpoint of the study is hemoglobin level variability
研究概览
简要总结
The purpose of this study es to determine hemoglobin variability in kidney transplant recipients with chronic renal anemia.
详细描述
The primary endpoint of the study is hemoglobin level variability. For determination of this variability, the following patterns of hemoglobin level change will be established:
- Target range hemoglobin (TRH): patients with hemoglobin values in the range of 11.0-12.0g/dl throughout the study period.
- Low hemoglobin (LH): patients with levels below 11.0g/dl
- High hemoglobin (HH): patients with levels above 12.0g/dl
- Low-amplitude fluctuation with low hemoglobin (LALH): patients with at least one measurement of hemoglobin levels <11.0g/dl and at least one measurement in the range of 11.0-12.0g/dl, but without hemoglobin measurements >12.0g/dl.
- Low-amplitude fluctuation with high hemoglobin (LAHH): patients with at least one measurement of hemoglobin levels >12.0g/dl and at least one measurement in the range of 11.0-12.0g/dl, but without hemoglobin measurements <11.0g/dl.
- High-amplitude fluctuation (HAH): patients with at least one measurement of hemoglobin levels <11.0g/dl and at least one measurement >12.0g/dl.
Secondary objectives:
- To determine potential factors influencing hemoglobin variability.
- To assess the influence of hemoglobin variability on cardiovascular risk of patients according to the REGICOR function at the end of the study period.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged > or = 18 years.
- •Kidney transplant recipients with chronic renal failure stage 3 (glomerular filtration rate: 30-59ml/min/1.73m2), 4 (glomerular filtration rate: 15-29ml/min/1.73m2) or 5 (glomerular filtration rate: <15ml/min/1.73m2) at the start of the study follow-up period.
- •Diagnosis of anemia and drug treatment initiated or changed subsequent to June 29, 2010 (date on which the latest recommendation by European Renal Best Practice on the target range for hemoglobin levels were published)
- •Patients capable of giving their informed consent to participate in the study and who agree to participate by signing the informed consent form.
排除标准
- •Patients whose medical history lacks measurements of hemoglobin levels every three months (±1 month) during the year of study follow-up.
结局指标
主要结局
The primary endpoint of the study is hemoglobin level variability
时间窗: the study includes the retrospective collection of information from the medical records of patients over a period of one year.
For determination of this variability, the following patterns of hemoglobin level change will be established: * Target range hemoglobin (TRH): patients who maintain hemoglobin values in the range of 11.0-12.0g/dl throughout the study period. - Low hemoglobin (LH): patients with hemoglobin levels below 11.0g/dl. * High hemoglobin (HH): patients with hemoglobin levels above 12.0g/dl. * Low-amplitude fluctuation with low hemoglobin (LALH): patients with at least one measurement of hemoglobin levels \<11.0g/dl and at least one measurement in the range of 11.0-12.0g/dl, but without hemoglobin measurements \>12.0g/dl. * Low-amplitude fluctuation with high hemoglobin (LAHH): patients with at least one measurement of hemoglobin levels \>12.0g/dl and at least one measurement in the range of 11.0-12.0g/dl, but without hemoglobin measurements \<11.0g/dl. * High-amplitude fluctuation (HAH): patients with at least one measure of hemoglobin levels \<11.0g/dl and at least one measurement \>12.0g/dl
次要结局
- Estimation of cardiovascular risk of patients(at the end of the study period (one year after the start of data recording))
- Potential factors influencing hemoglobin variability(Both baseline data and the changes recorded on the visit at month 12 will be considered.)