跳至主要内容
临床试验/NCT03867071
NCT03867071已完成不适用

Early Administration of Recombinant Erythropoietin (RHEPO) in Transfusion Savings in Trauma Patients

Centre Hospitalier Universitaire de Nīmes2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2005年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
number of administered red blood cells

研究概览

简要总结

The objective of our study is to demonstrate the interest of early administration of recombinant erythropoietin in trauma patients

详细描述

Could an early use of rHuEPO (recombinant Human ErythroPOietin ) be lead to an individual benefice on transfusion savings after traumatic surgery?

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients between 18 to 65 years old
  • Patient with an ASA 1 or 2 (ASA 1 corresponding to a patient in perfect health and ASA 2 to a patient with moderate involvement and well controlled organ function)
  • patient presenting at least one of the following fractures: Basin and / or femur with surgical indication, associated or not with other fractures.
  • patient with hemoglobin between 9 and 13 g / dl at the time of admission on trauma department

排除标准

  • patient with contraindication to synthetic erythropoietin
  • Patient with intravenous iron contraindication
  • pregnant patient or with a risk of pregnancy
  • patient who has not given his consent or does not understand the protocol
  • Patient with hemodynamic instability
  • patient participating in another research protocol for less than 3 months.

研究组 & 干预措施

Placebo (PLA) group

Placebo Comparator

干预措施: placebo injection (Other)

erythropoietin (EPO) group

Experimental

干预措施: recombinant erythropoietin injection (Other)

结局指标

主要结局

number of administered red blood cells

时间窗: Day 30

次要结局

未报告次要终点

研究者

发起方
Centre Hospitalier Universitaire de Nīmes
申办方类型
Other
责任方
Sponsor

研究点 (2)

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