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Oral Iron Substitution for Orthopedic Surgery

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02973074
Enrollment
20
Registered
2016-11-25
Start date
2016-11-25
Completion date
2017-11-01
Last updated
2018-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron Deficiency Anemia

Keywords

iron deficiency, patient blood management, anemia

Brief 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.

Detailed 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.

Interventions

DIETARY_SUPPLEMENTOLEOvital

2sachets with 30mg iron per day for a 4 weeks period

Sponsors

Kepler University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
increase of hemoglobin level4 weeks

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026