Iron Substitution After Total Knee Arthroplasty

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.

Study Overview

• Status: Completed
• Conditions: Haemodynamic Rebound
• Intervention / Treatment: Drug: Hemoboost; Drug: Kräuterblut; Drug: Ferrofumerat

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 Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 1

Contacts and Locations

Study Locations

• Denmark
  • Frederikshavn, Denmark
    • Frederikshavn Hospital, Aalborg Hospital/Aarhus University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Hemoboost (iron supplementation); A registered natural product containing specially haemolysed haemoglobin and iron dextran.	Drug: Hemoboost; 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.
ACTIVE_COMPARATOR: Kräuterblut (iron supplementation); A registered natural product made from a number of herbs with ferrous gluconate as the active substance.	Drug: Kräuterblut; 40 mg iron, 20 ml twice daily.; Other Names: No other names.
ACTIVE_COMPARATOR: Ferrofumerat (iron supplementation); Ferrous sulphate	Drug: Ferrofumerat; 200 mg ferrous sulphate as 1 tablet twice daily.; Other Names: No other names.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Haemoglobin concentration	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.	3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Northern Orthopaedic Division, Denmark
• Collaborators: Aalborg University
• Investigators: Principal Investigator: Sten Rasmussen, M.D.Sci., Orthopaedic Division, North Denmark Region, Aalborg University Hospital, Denmark; Study Chair: Søren Lundbye-Christensen, Ph.d., Aalborg University; Study Chair: Mogens B. Joergensen, M.D., Orthopaedic Division, North Denmark Region, Aalborg University Hospital, Denmark; Study Chair: Ole Simonsen, M.D., Orthopaedic Division, North Denmark Region, Aalborg University Hospital, Denmark

Study record dates

Study Major Dates

• Study Start: May 1, 2006
• Primary Completion (ACTUAL): December 1, 2006
• Study Completion (ACTUAL): June 1, 2007

Study Registration Dates

• First Submitted: May 29, 2012
• First Submitted That Met QC Criteria: May 31, 2012
• First Posted (ESTIMATE): June 4, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): March 31, 2014
• Last Update Submitted That Met QC Criteria: March 28, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: Iron supplementation; Iron deficiency; Knee arthroplasty; Hip arthroplasty
• Other Study ID Numbers: VN 2004/30