Haemodynamic Rebound
Conditions
Keywords
Iron supplementation, Iron deficiency, Hip arthroplasty, Knee arthroplasty
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.
Interventions
DRUGHemoboost
200 mg specially processed haemoglobin and 30 mg iron dextran equivalent to 10.5 mg organically bound iron in 1 tablet twice daily.
DRUGKräuterblut
40 mg iron, 20 ml twice daily.
DRUGFerrofumerat
200 mg ferrous sulphate as 1 tablet twice daily.
Sponsors
Aalborg University
Northern Orthopaedic Division, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Haemoglobin concentration | 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain measurement | 3 months | Pain scores on the Visual Analog Scale. |
| Consumption af analgesics | 3 months | — |
| Healing of ulcer | 3 months | — |
| Basic need for facilities | 3 months | — |
| Level of activity | 3 months | — |
Countries
Denmark
Outcome results
None listed