Iron Substitution After Total Knee Arthroplasty

This study has been completed.
Sponsor:
Collaborator:
Aalborg University
Information provided by (Responsible Party):
Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier:
NCT01611181
First received: May 29, 2012
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Haemodynamic Rebound
Drug: Hemoboost
Drug: Kräuterblut
Drug: Ferrofumerat
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Iron Substitution After Total Knee Arthroplasty - a Randomized Study

Resource links provided by NLM:


Further study details as provided by Northern Orthopaedic Division, Denmark:

Primary Outcome Measures:
  • Haemoglobin concentration [ Time Frame: 3 months ] [ Designated as safety issue: No ]

    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:
  • Pain measurement [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Pain scores on the Visual Analog Scale.

  • Consumption af analgesics [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Healing of ulcer [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Basic need for facilities [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Level of activity [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: May 2006
Study Completion Date: June 2007
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: No other names.
Active Comparator: Ferrofumerat (iron supplementation)
Ferrous sulphate
Drug: Ferrofumerat
200 mg ferrous sulphate as 1 tablet twice daily.
Other Name: No other names.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01611181

Locations
Denmark
Frederikshavn Hospital, Aalborg Hospital/Aarhus University
Frederikshavn, Denmark
Sponsors and Collaborators
Northern Orthopaedic Division, Denmark
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
  More Information

No publications provided

Responsible Party: Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier: NCT01611181     History of Changes
Other Study ID Numbers: VN 2004/30
Study First Received: May 29, 2012
Last Updated: March 28, 2014
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Northern Orthopaedic Division, Denmark:
Iron supplementation
Iron deficiency
Hip arthroplasty
Knee arthroplasty

Additional relevant MeSH terms:
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014