Iron Substitution After Total Knee Arthroplasty

Study Overview
=================
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.

Official Title
-----------------
Iron Substitution After Total Knee Arthroplasty - a Randomized Study

Conditions
-----------------
Haemodynamic Rebound

Intervention / Treatment
-----------------
* Drug: Hemoboost
* Drug: Kräuterblut
* Drug: Ferrofumerat


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hemoboost (iron supplementation)<br>A registered natural product containing specially haemolysed haemoglobin and iron dextran. | Drug: Hemoboost<br>* 200 mg specially processed haemoglobin and 30 mg iron dextran equivalent to 10.5 mg organically bound iron in 1 tablet twice daily.<br>* Other names: No other names.;|
| Active Comparator: Kräuterblut (iron supplementation)<br>A registered natural product made from a number of herbs with ferrous gluconate as the active substance. | Drug: Kräuterblut<br>* 40 mg iron, 20 ml twice daily.<br>* Other names: No other names.;|
| Active Comparator: Ferrofumerat (iron supplementation)<br>Ferrous sulphate | Drug: Ferrofumerat<br>* 200 mg ferrous sulphate as 1 tablet twice daily.<br>* 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Iron deficiency, Hip arthroplasty, Knee arthroplasty, Iron supplementation