Multicenter Double-bind Randomized Trial of Ferric Carboxymaltose With or Without Erythropoietin for the Prevention of Red-cell Transfusion in Hip Fracture Perioperative Period.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 303
- 试验地点
- 14
- 主要终点
- Reduce red-cell transfusion packs
研究概览
简要总结
In order to evaluate the efficacy of ferric carboxymaltose + erythropoietin versus ferric carboxymaltose versus placebo in reducing the percentage of patients who receive red-cell transfusion in the perioperative period of hip fracture, a multicenter, randomized, parallel groups, double-blind clinical trial in adult patients admitted for osteoporotic hip fracture is designed. Required sample size is of 87 patients per arm (87x3 = 261). Primary efficacy variable is the percentage of patients who receive red-cell transfusion during hospitalization; secondary end-points: average red-cell packs per patient,haemoglobin at 24 h and 72h after the intervention, at the time of hospital discharge and 60 days after hospital discharge, hospital stay and mortality during hospital-stay and 60 days afterwards. Adverse clinical events and side effects are assessed as safety variables. In addition health related quality of life will be measured at inclusion and after 60 days. A cost-efficacy analysis (by means of incremental cost-efficacy method using as a primary endpoint each patient not requiring transfusion, and as secondary end-point every patient who survived the index admission is performed). The investigators would like to demonstrate a double benefits: optimizing precious resource such as blood products and reducing complications arising from their use.
详细描述
Three arms of treatments: A: ferric carboxymaltose and erythropoietin, B: ferric carboxymaltose and placebo, arm C: two placebos. Primary objective:reduction of red-cell packs needed for elderly patients with osteoporotic hip fracture which requires surgical intervention in the perioperative period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —(Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 65 years and older.
- •Osteoporotic hip fracture which require surgical intervention
- •Haemoglobin levels between 90-120 g/L
- •Signed informed consent form
排除标准
- •Bone marrow diseases which could interfere in the erythropoietic process (acute or chronic myelodysplastic syndromes or myeloproliferative diseases, and/or infiltration of the bone marrow due to solid or lymphatic neoplasms)
- •Blood coagulation diseases or currently treated with oral anticoagulants and/or heparin at therapeutic doses.
- •Documented allergy and/or previous intolerance and/or contraindication of erythropoietin use and/or intravenous iron.
- •Patients with rheumatoid arthritis and/or another demonstrated origin of inflammatory anemia and/or not controlled arterial hypertension.
研究组 & 干预措施
Placebo
Two placebos: placebo for ferric carboxymaltose and placebo for erythropoietin
干预措施: Placebo (Drug)
FE
Ferric carboxymaltose and placebo for erythropoietin
干预措施: Ferric carboxymaltose (Drug)
EPOFE
Ferric carboxymaltose and erythropoietin
干预措施: Ferric carboxymaltose (Drug)
EPOFE
Ferric carboxymaltose and erythropoietin
干预措施: Erythropoietin (Drug)
结局指标
主要结局
Reduce red-cell transfusion packs
时间窗: 60 days after hospital discharge
percentage of patients who receive red-cell transfusion during hospitalization
次要结局
- Average red-cell packs per patient(end of study)
- Haemoglobin level(24 h and 72h after the intervention, at the time of hospital discharge and 60 days after hospital discharge)
- Number of hospitalization days(end of study)
- Death rate with all causes mortality(end of study)
- Adverse Events(end of study)
- Quality of life(end of study)
- cost-efficacy analysis(end of study)
研究者
Maximo Bernabeu Wittel
Maximo Bernabeu Wittel
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
