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临床试验/NCT01154491
NCT01154491已完成3 期

Multicenter Double-bind Randomized Trial of Ferric Carboxymaltose With or Without Erythropoietin for the Prevention of Red-cell Transfusion in Hip Fracture Perioperative Period.

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla14 个研究点 分布在 1 个国家目标入组 303 人开始时间: 2010年6月最近更新:
适应症
干预措施
相关药物

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

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

Placebo Comparator

Two placebos: placebo for ferric carboxymaltose and placebo for erythropoietin

干预措施: Placebo (Drug)

FE

Experimental

Ferric carboxymaltose and placebo for erythropoietin

干预措施: Ferric carboxymaltose (Drug)

EPOFE

Experimental

Ferric carboxymaltose and erythropoietin

干预措施: Ferric carboxymaltose (Drug)

EPOFE

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maximo Bernabeu Wittel

Maximo Bernabeu Wittel

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

研究点 (14)

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