Haemodynamic Rebound Clinical Trial
Official title:
Iron Substitution After Total Knee Arthroplasty - a Randomized Study
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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