Iron Substitution After Total Knee Arthroplasty

Phase 1

Completed

• Conditions: Haemodynamic Rebound
• Interventions: Drug: Hemoboost; Drug: Kräuterblut; Drug: Ferrofumerat

• Registration Number: NCT01611181
• Lead Sponsor: Northern Orthopaedic Division, Denmark

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2006-05
• Primary Completion: 2006-12
• Study Completion: 2007-06
• Study First Submitted: 2012-05-29
• Study First Submitted QC: 2012-05-31
• Study First Posted: 2012-06-04
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-28
• Last Update Posted: 2014-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hemoboost (iron supplementation)	Hemoboost	A registered natural product containing specially haemolysed haemoglobin and iron dextran.
Kräuterblut (iron supplementation)	Kräuterblut	A registered natural product made from a number of herbs with ferrous gluconate as the active substance.
Ferrofumerat (iron supplementation)	Ferrofumerat	Ferrous sulphate

Primary Outcome Measures

Name	Time	Method
Haemoglobin concentration	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 Outcome Measures

Name	Time	Method
Basic need for facilities	3 months
Level of activity	3 months
Pain measurement	3 months	Pain scores on the Visual Analog Scale.
Consumption af analgesics	3 months
Healing of ulcer	3 months

Trial Locations

Locations (1)

Frederikshavn Hospital, Aalborg Hospital/Aarhus University; 🇩🇰 Frederikshavn, Denmark