Clinical trial NCT01611181: Iron Substitution After Total Knee Arthroplasty
Official title: Iron Substitution After Total Knee Arthroplasty - a Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Haemodynamic Rebound
Keywords: Iron supplementation
Iron deficiency
Hip arthroplasty
Knee arthroplasty
Lead sponsor: Northern Orthopaedic Division, Denmark
Sponsor class: OTHER
Collaborators: name: Aalborg University
First posted: 2012-06-04
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Haemoglobin concentration
timeFrame: 3 months
Secondary outcomes:
measure: Pain measurement
timeFrame: 3 months
measure: Consumption af analgesics
timeFrame: 3 months
measure: Healing of ulcer
timeFrame: 3 months
measure: Basic need for facilities
timeFrame: 3 months
measure: Level of activity
timeFrame: 3 months
Other outcomes:
Locations:
city: Frederikshavn
country: Denmark
facility: Frederikshavn Hospital, Aalborg Hospital/Aarhus University
Study officials:
affiliation: Orthopaedic Division, North Denmark Region, Aalborg University Hospital, Denmark
name: Sten Rasmussen, M.D.Sci.
role: PRINCIPAL_INVESTIGATOR
affiliation: Aalborg University
name: Søren Lundbye-Christensen, Ph.d.
role: STUDY_CHAIR
affiliation: Orthopaedic Division, North Denmark Region, Aalborg University Hospital, Denmark
name: Mogens B. Joergensen, M.D.
role: STUDY_CHAIR
affiliation: Orthopaedic Division, North Denmark Region, Aalborg University Hospital, Denmark
name: Ole Simonsen, M.D.
role: STUDY_CHAIR
References: