Oral Iron Substitution for Orthopedic Surgery

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02973074
• Date of registration: 22/11/2016
• Prospective Registration: Yes
• Primary sponsor: Kepler University Hospital
• Public title: Oral Iron Substitution for Orthopedic Surgery
• Scientific 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
• Date of first enrolment: November 25, 2016
• Target sample size: 20
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02973074
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Austria

Contacts

• Name: Jens Meier, Prof. Dr.
• Affiliation: Kepler University Hospital Linz, Clinic for Anesthesiology and intensive care medicine

Key inclusion & exclusion 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



Age minimum: 55 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Iron Deficiency Anemia

Intervention(s)

Dietary Supplement: OLEOvital

Primary Outcome(s)

increase of hemoglobin level [Time Frame: 4 weeks]

Secondary ID(s)

C-124-16

Source(s) of Monetary Support

Please refer to primary and secondary sponsors