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| Name | Class |
|---|---|
| Aalborg University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemoboost (iron supplementation) | Active Comparator | A registered natural product containing specially haemolysed haemoglobin and iron dextran. |
|
| Kräuterblut (iron supplementation) | Active Comparator | A registered natural product made from a number of herbs with ferrous gluconate as the active substance. |
|
| Ferrofumerat (iron supplementation) | Active Comparator | Ferrous sulphate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemoboost | Drug | 200 mg specially processed haemoglobin and 30 mg iron dextran equivalent to 10.5 mg organically bound iron in 1 tablet twice daily. |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain measurement | Pain scores on the Visual Analog Scale. | 3 months |
| Consumption af analgesics | 3 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sten Rasmussen, M.D.Sci. | Orthopaedic Division, North Denmark Region, Aalborg University Hospital, Denmark | Principal Investigator |
| 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 | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Frederikshavn Hospital, Aalborg Hospital/Aarhus University | Frederikshavn | Denmark |
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| ID | Term |
|---|---|
| D000090463 | Iron Deficiencies |
| ID | Term |
|---|---|
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| Kräuterblut | Drug | 40 mg iron, 20 ml twice daily. |
|
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| Ferrofumerat | Drug | 200 mg ferrous sulphate as 1 tablet twice daily. |
|
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| Healing of ulcer |
| 3 months |
| Basic need for facilities | 3 months |
| Level of activity | 3 months |