Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
20 participants
INTERVENTIONAL
2016-11-25
2017-11-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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OLEOvital
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
OLEOvital
2sachets with 30mg iron per day for a 4 weeks period
Interventions
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OLEOvital
2sachets with 30mg iron per day for a 4 weeks period
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
55 Years
ALL
No
Sponsors
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Kepler University Hospital
OTHER
Responsible Party
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Nina Pauker, MD
Dr. med. univ.
Principal Investigators
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Jens Meier, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Kepler University Hospital Linz, Clinic for Anesthesiology and intensive care medicine
Locations
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Kepler University Hospital
Linz, , Austria
Countries
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References
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Gombotz H, Rehak PH, Shander A, Hofmann A. Blood use in elective surgery: the Austrian benchmark study. Transfusion. 2007 Aug;47(8):1468-80. doi: 10.1111/j.1537-2995.2007.01286.x.
Seicean A, Alan N, Seicean S, Neuhauser D, Weil RJ. The effect of blood transfusion on short-term, perioperative outcomes in elective spine surgery. J Clin Neurosci. 2014 Sep;21(9):1579-85. doi: 10.1016/j.jocn.2014.03.003. Epub 2014 May 19.
Danninger T, Rasul R, Poeran J, Stundner O, Mazumdar M, Fleischut PM, Poultsides L, Memtsoudis SG. Blood transfusions in total hip and knee arthroplasty: an analysis of outcomes. ScientificWorldJournal. 2014 Jan 21;2014:623460. doi: 10.1155/2014/623460. eCollection 2014.
Meybohm P, Richards T, Isbister J, Hofmann A, Shander A, Goodnough LT, Munoz M, Gombotz H, Weber CF, Choorapoikayil S, Spahn DR, Zacharowski K. Patient Blood Management Bundles to Facilitate Implementation. Transfus Med Rev. 2017 Jan;31(1):62-71. doi: 10.1016/j.tmrv.2016.05.012. Epub 2016 May 28.
Other Identifiers
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C-124-16
Identifier Type: -
Identifier Source: org_study_id
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