Predicting Iron Deficiency and Related Iron Parameters Outside Inflammation in Hospitalized Elderly Patients: A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Proportion of patients with iron deficiency, defined as transferrin saturation < 20% (pilot phase)
研究概览
简要总结
In elderly adults, anemia is common and multifactorial. Inflammation, which is frequently observed in hospitalized elderly patients, profoundly alters iron metabolism, making it difficult to accurately assess true iron status.
The objective of this study is to identify a predictive model that can estimate iron deficiency status in the absence of inflammation using transferrin saturation (TSAT) measured during an inflammatory phase. This model could help distinguish true iron deficiency from anemia of inflammation, improve patient management, and reduce decision-making delays.
The study will be conducted in two distinct phases: a pilot phase involving up to 200 patients at a single center in France, followed by a main phase involving 1,523 patients across multiple centers in France. Participants will be adults aged over 75 years who are hospitalized in a geriatric ward and present with an acute inflammatory episode (C-reactive protein [CRP] > 50 mg/L).
In addition to routine analyses performed during hospitalization, supplementary laboratory analyses will be carried out. Following admission in hospital, patients will receive standard medical care. Upon admission or on the following day, patients, their trusted representative, or relatives will be informed about the study. If eligibility criteria are met, the patient will be enrolled.
Research-specific laboratory analyses will be performed on blood samples collected at 4 times:
- the day after admission;
- when CRP < 20 mg/L (pilot phase only);
- when CRP < 10 mg/L;
- five days after a CRP < 10 mg/L. These additional analyses will not require another blood sample, as they will be performed on samples collected as part of routine clinical care. They constitute the main research specific intervention.
详细描述
In elderly adults, anemia is common and multifactorial. Inflammation, which is frequently observed in hospitalized elderly patients, profoundly alters iron metabolism, making it difficult to accurately assess true iron status.
The objective of this study is to identify a predictive model that can estimate iron deficiency status in the absence of inflammation using transferrin saturation (TSAT) measured during an inflammatory phase. This model could help distinguish true iron deficiency from anemia of inflammation, improve patient management, and reduce decision-making delays.
The study will be conducted in two distinct phases:
- Pilot phase: A prospective, observational, single-center study enrolling up to 200 patients or conducted over a maximum recruitment period of one year, whichever occurs first.
- Main phase: A prospective, observational, multicenter study with the consecutive enrollment of 1,523 patients, including patients enrolled during the pilot phase.
The primary objective of the pilot phase is to estimate the proportion of patients with iron deficiency, defined as a transferrin saturation (TSAT) < 20%, in order to confirm the prevalence assumption that will be used in the sample size calculation for the development of a predictive model of iron deficiency in the absence of inflammation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 75 years.
- •Hospitalization with CRP > 50 mg/L at admission.
- •Non-opposition expressed by patient or legally authorized representative
排除标准
- •Advanced chronic kidney disease (estimated glomerular filtration rate < 30 mL/min/1.73 m²) or chronic dialysis.
- •Severe hepatic impairment (Child-Pugh score B or C).
- •Severe hematological disorders (active hematologic malignancy or known myelodysplastic syndrome) or known iron metabolism disorders that may bias the study results (e.g., thalassemia, advanced hemochromatosis).
- •Hemoglobin < 9g/L
- •Treatment with intravenous iron within 12 weeks or oral iron within 4 weeks prior to enrollment.
- •Blood transfusion within 3 months prior to enrollment
- •Ongoing treatment with erythropoiesis-stimulating agents.
- •Ongoing cytotoxic chemotherapy.
- •Active bleeding at the time of enrollment.
- •Very limited life expectancy or inability to ensure follow-up (end-of-life care).
- •Participation in another investigational medicinal product study
研究组 & 干预措施
Elderly patients with acute inflammation
Hospitalized patients aged >75 years admitted to hospital with an acute inflammatory episode (CRP > 50 mg/L).
干预措施: Analysis of biological parameters (Diagnostic Test)
结局指标
主要结局
Proportion of patients with iron deficiency, defined as transferrin saturation < 20% (pilot phase)
时间窗: From enrollment to the end of study at 4 weeks maximum
To estimate the proportion of patients with iron deficiency, defined as transferrin saturation (TSAT) \< 20%, in order to validate the prevalence assumption that will be used in the sample size calculation for the development of a predictive model of iron deficiency under non-inflammatory conditions
To develop a predictive model for iron deficiency, defined by TSAT under non-inflammatory conditions (defined as CRP<10 mg/L or <20 mg/L, depending on results of pilot phase), using measurements obtained during acute inflammatory episode (main phase)
时间窗: From enrollment to the end of study at 4 weeks maximum
Transferrin saturation (TSAT) will be measured at baseline and when CRP \< 10 mg/L (or \< 20 mg/L, depending on results of the pilot phase). Iron deficiency will be defined as a TSAT \< 20%. The predictive performance of the model for estimating TSAT under non-inflammatory conditions and the agreement between predicted and observed TSAT values under non-inflammatory conditions will be assessed.
次要结局
- Proportion of patients with CRP < 20 mg/L and proportion of patients with CRP < 10 mg/L in the study population (pilot phase)(From enrollment to the end of study at 4 weeks maximum)
- Among the clinically relevant variables, and within subgroups of patients with CRP < 20 mg/L and < 10 mg/L (pilot phase), to examine a/the collinearity structure among potential predictors ; b/the distribution of categorical variables(From enrollment to the end of study at 4 weeks maximum)
- To assess the correlation between transferrin saturation measured during an inflammatory state and transferrin saturation measured under non-inflammatory conditions.(From enrollment to the end of study at 4 weeks maximum)
- To develop and validate a predictive model for iron deficiency, defined by ferritin levels under non-inflammatory conditions, with non-inflammation defined as CRP < 10 mg/L (or < 20 mg/L, depending on the results of the pilot phase).(From enrollment to the end of study at 4 weeks maximum)
- To assess the evolution of iron status parameters when CRP < 10mg/l and 5 days post CRP < 10mg/l.(From enrollment to the end of study at 4 weeks maximum)