Oral Iron Substitution for Orthopedic Surgery

Kepler University Hospital

Status: Terminated

Conditions: Iron Deficiency Anemia

Treatments: Dietary Supplement: OLEOvital

Study type: Interventional

Funder types: Other

Identifiers

NCT02973074

C-124-16

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

OLEOvital

Other group

Description:

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

Treatment:

Dietary Supplement: OLEOvital