NCT02973074

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 25, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

November 25, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

August 9, 2018

Status Verified

August 1, 2018

Enrollment Period

11 months

First QC Date

November 22, 2016

Last Update Submit

August 7, 2018

Conditions

Iron Deficiency Anemia

Keywords

iron deficiencypatient blood managementanemia

Outcome Measures

Primary Outcomes (1)

  • increase of hemoglobin level

    4 weeks

Study Arms (1)

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

OLEOvitalDIETARY_SUPPLEMENT

2sachets with 30mg iron per day for a 4 weeks period

OLEOvital

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kepler University Hospital

Linz, 4020, Austria

Location

Related Publications (4)

  • 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.

    PMID: 17655591BACKGROUND

  • 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.

    PMID: 24852902BACKGROUND

  • 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.

    PMID: 24587736BACKGROUND

  • 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.

    PMID: 27317382BACKGROUND

MeSH Terms

Conditions

Anemia, Iron-DeficiencyIron DeficienciesAnemia

Condition Hierarchy (Ancestors)

Anemia, HypochromicHematologic DiseasesHemic and Lymphatic DiseasesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Jens Meier, Prof. Dr.

    Kepler University Hospital Linz, Clinic for Anesthesiology and intensive care medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med. univ.

Study Record Dates

First Submitted

November 22, 2016

First Posted

November 25, 2016

Study Start

November 25, 2016

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

August 9, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)