Iron Substitution After Total Knee Arthroplasty

Haemodynamic Rebound Clinical Trial

Official title:

Iron Substitution After Total Knee Arthroplasty - a Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01611181
• Other study ID #: VN 2004/30
• Status: Completed
• Phase: Phase 1
• First received: May 29, 2012
• Last updated: March 28, 2014
• Start date: May 2006
• Est. completion date: June 2007

Study information

• Verified date: March 2014
• Source: Northern Orthopaedic Division, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: June 2007
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Haemodynamic Rebound

Intervention

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.
• Kräuterblut
40 mg iron, 20 ml twice daily.
• Ferrofumerat
200 mg ferrous sulphate as 1 tablet twice daily.

Locations

Country	Name	City	State
Denmark	Frederikshavn Hospital, Aalborg Hospital/Aarhus University	Frederikshavn

Sponsors (2)

Lead Sponsor	Collaborator
Northern Orthopaedic Division, Denmark	Aalborg University

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Pain measurement	Pain scores on the Visual Analog Scale.	3 months	No
Secondary	Consumption af analgesics		3 months	No
Secondary	Healing of ulcer		3 months	No
Secondary	Basic need for facilities		3 months	No
Secondary	Level of activity		3 months	No