Oral Iron Substitution for Orthopedic Surgery

Study Overview
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Brief Summary
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The aim of this pilot study is to investigate an 4 weeks period of oral iron substitution in the course of Patient Blood Management in preparation for orthopedic surgery.

Detailed Description
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Patient blood management (PBM) is a clinical multidisciplinary, patient orientated concept for treatment of anaemia, reduction of intraoperative blood loss and increasing anaemic tolerance. In the Kepler University Hospital (former General Hospital Linz) PBM was introduced in 2006. Since then patients for elective orthopedic surgery (knee an hip replacement) are screened for iron deficiency anaemia and if needed treated with the more effective intravenous iron. Oral iron medications are not as efficient (low bioavailability, more side effects) as the intravenous iron infusion. Although there is risk of anaphylactoid reactions. In this study the new oral iron supplement OLEOvital Eisen forte (available in Austria) ist tested on its effectivity for treatment of iron deficiency in the course of PBM. It has a much more higher bioavailability without the typically side effects of the routinely used oral iron medications. Within this study the investigators want to examine the feasibility of this iron substitution concept OLEOvital and its efficacy. Also the investigators want to get pilot data for a further randomized controlled trial. The increase of the hemoglobin level in 4 weeks of minimum 1g/dl is going to be expected and monitored. For comparison of the new oral substitution concept OLEOvital with the standard intravenous iron substitution an historic control group is going to be used.

Official Title
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Pilot Study for Investigation of the Feasibility and for Optimization of Oral Iron Substitution in the Course of Patient Blood Management for Orthopedic Surgery

Conditions
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Iron Deficiency Anemia

Intervention / Treatment
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* Dietary Supplement: OLEOvital


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age over 55 years indication for patient blood management for elective orthopedic surgery listed for a orthopedic surgery (e.g. hip or knee replacement) 5-7 weeks after begin of patient blood management Haemoglobin male < 12-13g/dl, female <11-12g/dl written informed consent after written and verbal information Exclusion Criteria: indication for treatment with erythropoietin pregnancy nursing period diarrhea or tendency to diarrhea fructose intolerance pre - menopause permanent or expected blood loss participation in other study expected compliance problems legal incapacity

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: OLEOvital<br>30mg iron are being administered orally twice a day for a period of 4 Weeks it is a granulated powder which is taken orally and then solved with saliva, without taking water | Dietary Supplement: OLEOvital<br>* 2sachets with 30mg iron per day for a 4 weeks period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| increase of hemoglobin level |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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iron deficiency, patient blood management, anemia