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临床试验/NCT00919230
NCT00919230已完成3 期

Randomised Trial Comparing Iron Supplementation Versus Placebo in the Treatment of Anaemia After Hip Fracture

Peterborough and Stamford Hospitals NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2004年7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
发起方
入组人数
300
试验地点
1
主要终点
6 week hemoglobin

研究概览

简要总结

At present our current practice is to provide a course of oral iron therapy for those patients with a post-operative haemoglobin which is below normal, but not severe enough to require a blood transfusion. Such a practice is not without side effects from the iron tablets, namely ingestion, nausea, diarrhoea, constipation. There is little evidence in the literature to support the current practice of using iron, with only one small randomised trial suggesting such therapy is unnecessary. We propose to recruit 300 patients recovering from a hip fracture with a post-operative haemoglobin below 11g/l. For those patients willing to enter the study, half will be given oral iron therapy (ferrous sulphate 200mg twice daily) for one month. The haemoglobin will be checked when the patients attends the hip fracture clinic at 6 weeks after discharge.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • patients with anaemia after surgery for a hip fracture

排除标准

  • absence of anaemia, inability to provide consent

研究组 & 干预措施

ferrous sulphate

Experimental

iron given

干预措施: Ferrous sulphate tablets (Drug)

结局指标

主要结局

6 week hemoglobin

时间窗: 6 weeks after surgery

次要结局

  • Length of hospital stay side effects of therapy mortality(one year)

研究者

发起方
Peterborough and Stamford Hospitals NHS Foundation Trust
申办方类型
Other
责任方
Principal Investigator
主要研究者

Martyn J Parker

research fellow

Peterborough and Stamford Hospitals NHS Foundation Trust

研究点 (1)

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