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Iron Substitution After Total Knee Arthroplasty

NCT01611181 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2014-03-31

No results posted yet for this study

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.

Conditions

  • Haemodynamic Rebound

Interventions

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.

DRUG

Kräuterblut

40 mg iron, 20 ml twice daily.

DRUG

Ferrofumerat

200 mg ferrous sulphate as 1 tablet twice daily.

Sponsors & Collaborators

  • Aalborg University

    collaborator OTHER

  • Northern Orthopaedic Division, Denmark

    lead OTHER

Principal Investigators

  • Sten Rasmussen, M.D.Sci. · Orthopaedic Division, North Denmark Region, Aalborg University Hospital, Denmark

  • Søren Lundbye-Christensen, Ph.d. · Aalborg University

  • Mogens B. Joergensen, M.D. · Orthopaedic Division, North Denmark Region, Aalborg University Hospital, Denmark

  • Ole Simonsen, M.D. · Orthopaedic Division, North Denmark Region, Aalborg University Hospital, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2006-12-31
Completion
2007-06-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01611181 on ClinicalTrials.gov