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Oral Iron Substitution for Orthopedic Surgery

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ClinicalTrials.gov Identifier: NCT02973074
Recruitment Status : Recruiting
First Posted : November 25, 2016
Last Update Posted : November 29, 2016
Sponsor:
Information provided by (Responsible Party):
Nina Pauker, MD, Kepler University Hospital

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.

Condition or disease Intervention/treatment Phase
Iron Deficiency Anemia Dietary Supplement: OLEOvital Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 2016
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron

Arm Intervention/treatment
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
Dietary Supplement: OLEOvital
2sachets with 30mg iron per day for a 4 weeks period




Primary Outcome Measures :
  1. increase of hemoglobin level [ Time Frame: 4 weeks ]


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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
Contact: Jens Meier, Prof.Dr. 004357680832158 jens.meier@kepleruniklinikum.at
Contact: Nina Pauker, Dr. 0043576808378168 nina.pauker@kepleruniklinikum.at

Locations
Austria
Kepler University Hospital Recruiting
Linz, Austria, 4020
Contact: Jens Meier, Prof. Dr.    004357680832158    jens.meier@kepleruniklinikum.at   
Sub-Investigator: Nina Pauker, Dr.         
Principal Investigator: Jens Meier, Prof. Dr.         
Sponsors and Collaborators
Kepler University Hospital
Investigators
Principal Investigator: Jens Meier, Prof. Dr. Kepler University Hospital Linz, Clinic for Anesthesiology and intensive care medicine

Publications:
Responsible Party: Nina Pauker, MD, Dr. med. univ., Kepler University Hospital
ClinicalTrials.gov Identifier: NCT02973074     History of Changes
Other Study ID Numbers: C-124-16
First Posted: November 25, 2016    Key Record Dates
Last Update Posted: November 29, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Nina Pauker, MD, Kepler University Hospital:
iron deficiency
patient blood management
anemia

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs