Iron Substitution After Total Knee Arthroplasty - a Randomized Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Haemoglobin concentration
研究概览
简要总结
Hemoboost is a registered natural product containing specially processed haemolysed haemoglobin and iron dextran. It is marketed for human use on the basis of many years' use and documented effect in veterinary medicine. Iron dextran was introduced for use in human medicine in 1954.
Krauterblut is a registered natural product made from a number of herbs where the active substance is ferrous gluconate. Both drugs have been available for a number of years and have become increasingly popular among patients and healthcare staff due to a reduction in adverse effects.
The objective of this study is to determine the effect and adverse effects of the natural products Hemoboost and Kräuterblut compared with the usually administered ferrous sulphate in knee arthroplasty.
详细描述
Hip and knee arthroplasties are performed with increasing frequency in the western world, and in Denmark approximately 12,000 operations are performed annually (2/1000/year). The perioperative and postoperative blood loss generally constitutes ½ -1½ litres which is frequently associated with symptom-producing anaemia which obstructs mobilisation and increases the risk of complications.
Postoperative iron supplementation for a period of up to 12 weeks is therefore a frequently adopted practice. However, there is no consensus or evidence that support postoperative iron supplementation and the effects of iron deficiency are unclear. It is well-known that iron supplementation causes gastrointestinal adverse effects in up to 25% of cases.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 18 years
- •ASA group I-II
排除标准
- •malignant disorder
- •chronic renal insufficiency
- •urinary tract infection
- •haemorrhagic diathesis
- •haemoglobin < 7 mmol/l
- •dementia or mental disorder incompatible with survey participation
研究组 & 干预措施
Hemoboost (iron supplementation)
A registered natural product containing specially haemolysed haemoglobin and iron dextran.
干预措施: Hemoboost (Drug)
Kräuterblut (iron supplementation)
A registered natural product made from a number of herbs with ferrous gluconate as the active substance.
干预措施: Kräuterblut (Drug)
Ferrofumerat (iron supplementation)
Ferrous sulphate
干预措施: Ferrofumerat (Drug)
结局指标
主要结局
Haemoglobin concentration
时间窗: 3 months
Determine whether peroral iron substitution of Hemo-Boost or Krauterblut results in the same increase of haemoglobin concentration as the usually administered ferrous sulphate. To study the adverse effects of the natural products Hemo-Boost and Krauterblut compared with ferrous sulphate in knee arthroplasty.
次要结局
- Basic need for facilities(3 months)
- Level of activity(3 months)
- Pain measurement(3 months)
- Consumption af analgesics(3 months)
- Healing of ulcer(3 months)