Oral Iron Substitution for Orthopedic Surgery
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|ClinicalTrials.gov Identifier: NCT02973074|
Recruitment Status : Terminated (no enough partícipants enrolled in the 1 year planned for recruitment)
First Posted : November 25, 2016
Last Update Posted : August 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Iron Deficiency Anemia||Dietary Supplement: OLEOvital||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study for Investigation of the Feasibility and for Optimization of Oral Iron Substitution in the Course of Patient Blood Management for Orthopedic Surgery|
|Study Start Date :||November 25, 2016|
|Actual Primary Completion Date :||November 1, 2017|
|Actual Study Completion Date :||November 1, 2017|
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
2sachets with 30mg iron per day for a 4 weeks period
- increase of hemoglobin level [ Time Frame: 4 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02973074
|Kepler University Hospital|
|Linz, Austria, 4020|
|Principal Investigator:||Jens Meier, Prof. Dr.||Kepler University Hospital Linz, Clinic for Anesthesiology and intensive care medicine|