Oral Iron Substitution for Orthopedic Surgery | NCT02973074

Studies
Oral Iron Substitution for Orthopedic Surgery

NCT02973074

Sponsor

Kepler University Hospital

Status

Terminated

Last Update Posted

Aug 9, 2018Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Iron Deficiency Anemia

Interventions

OLEOvital

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

no enough partícipants enrolled in the 1 year planned for recruitment

Expanded Access Info

Start Date

Nov 25, 2016

Primary Completion Date

Nov 1, 2017Actual

Completion Date

Nov 1, 2017Actual

First Submitted Date

Nov 22, 2016

First Submission Date that Met QC Criteria

Nov 23, 2016

First Posted Date

Nov 25, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 7, 2018

Last Update Posted Date

Aug 9, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nina Pauker, MD, Dr. med. univ., Kepler University HospitalPrincipal Investigator

Lead Sponsor

Kepler University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
OLEOvital	Other	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
OLEOvital	Dietary Supplement	2sachets with 30mg iron per day for a 4 weeks period	OLEOvital

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
increase of hemoglobin level		4 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jens Meier, Prof. Dr.	Kepler University Hospital Linz, Clinic for Anesthesiology and intensive care medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kepler University Hospital		Linz		4020	Austria

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17655591	Background	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.
24852902	Background	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.

ID	Term
D018798	Anemia, Iron-Deficiency
D000090463	Iron Deficiencies
D000740	Anemia

ID	Term
D000747	Anemia, Hypochromic
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D019189	Iron Metabolism Disorders