Preoperative Supplementation of Sucrosomal Iron as Hematopoietic Support.
Preop Iron
Einfluss Eines Oralen Eisenpräparats Mit Hoher Bioverfügbarkeit (OLEOvital® EISEN FORTE) Auf Die präoperative Hämoglobinkonzentration Bei anämischen Patienten
1 other identifier
interventional
200
1 country
1
Brief Summary
To prove, if preoperative elective anemic patients improve their hemoglobin levels within 3-6 weeks preoperativly after daily oral dietary supplementation of 60mg sucrosomal iron.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2019
CompletedFirst Submitted
Initial submission to the registry
April 15, 2020
CompletedFirst Posted
Study publicly available on registry
April 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedApril 17, 2020
April 1, 2020
2 years
April 15, 2020
April 15, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
hemoglobin
1 g/dl increase
3 - 6 weeks
Study Arms (4)
Verum
EXPERIMENTALoral dose of 2 x 30mg (=60mg) Oleovital® Eisen Forte p.o. per day over a limited intake of 3-6 weeks due to increased physiological iron demand
Control group
NO INTERVENTIONno intervention
Patient with menstral bleeding - subcollective A
OTHERverum or control
Patient without menstral bleeding - subcollective B
OTHERverum or control
Interventions
60 mg daily oral Supplementation for 3 to 6 weeks
Eligibility Criteria
You may qualify if:
- Written consent according to previous written and oral clarification
- Elective intervention in 3-6 weeks
- Hemoglobin (Hb) -12.0g/dl
- Age \>18 years
- Non-cardiac surgery
You may not qualify if:
- Non-business capability or legal representation
- Pregnancy
- Breastfeeding period
- Chronic diarrhoea (\> 4 weeks)
- Known massive absorption restriction (e.g. short bowel syndrome)
- Known or suspected fructose intolerance
- Iron accumulation disorders: hemochromatosis, hemosiderosis
- Vegan diet
- Use of a preparation to specifically increase the body's own erythrocyte or hemoglobin concentration or production (e.g. EPO preparations, erythrocyte concentrates) in the last 4 weeks
- Permanent or preoperativeblood loss (e.g. seepage bleeding)
- Intended intake/application of another iron-supplementing preparation before surgery
- Intended use of preparations to specifically increase the body's own erythrocyte or hemoglobin concentration or production (e.g. EPO preparations, erythrocyte concentrates) prior to surgery
- Simultaneous participation in another clinical trial with insurance cover
- Foreseeable compliance issues
- Existing refractory disorder of the bone marrow: myelodysplasia
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anestesiology and Critical Care Medicine
Vienna, Penzing, 1140, Austria
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D. MSc.
Study Record Dates
First Submitted
April 15, 2020
First Posted
April 17, 2020
Study Start
October 1, 2019
Primary Completion
October 1, 2021
Study Completion
October 1, 2022
Last Updated
April 17, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share