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NCT Number: NCT01611181

Iron Substitution After Total Knee Arthroplasty

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.

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Key information

Conditions

Haemodynamic Rebound Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Frederikshavn Hospital, Aalborg Hospital/Aarhus University

Frederikshavn, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age > 18 years
  • ASA group I-II

Exclusion criteria

  • malignant disorder
  • chronic renal insufficiency
  • urinary tract infection
  • haemorrhagic diathesis
  • haemoglobin < 7 mmol/l
  • dementia or mental disorder incompatible with survey participation

Treatment and study plan

Hemoboost

Drug

200 mg specially processed haemoglobin and 30 mg iron dextran equivalent to 10.5 mg organically bound iron in 1 tablet twice daily.

Other names: No other names.

Kräuterblut

Drug

40 mg iron, 20 ml twice daily.

Other names: No other names.

Ferrofumerat

Drug

200 mg ferrous sulphate as 1 tablet twice daily.

Other names: No other names.

Primary outcomes

  1. Haemoglobin concentration

    Time frame: 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.

Secondary outcomes

  1. Pain measurement

    Time frame: 3 months

    Pain scores on the Visual Analog Scale.

  2. Consumption af analgesics

    Time frame: 3 months

  3. Healing of ulcer

    Time frame: 3 months

  4. Basic need for facilities

    Time frame: 3 months

  5. Level of activity

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Northern Orthopaedic Division, Denmark

Other

Collaborators

  • Aalborg University

Registry information

Official study title

Iron Substitution After Total Knee Arthroplasty - a Randomized Study

Important dates

Study start
2006
Primary completion
2006
Study completion
2007
First posted
Jun 4, 2012
Registry last updated
Mar 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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