Oral Iron Substitution for Orthopedic Surgery

Status Terminated

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02973074
Study type	Interventional
Source	Kepler University Hospital
Contact
Status	Terminated
Phase	N/A
Start date	November 25, 2016
Completion date	November 1, 2017

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