Status:
UNKNOWN
Preoperative Supplementation of Sucrosomal Iron as Hematopoietic Support.
Lead Sponsor:
Mein Hanusch-Krankenhaus
Conditions:
Anemia, Iron-Deficiency
Eligibility:
All Genders
18+ years
Phase:
NA
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.
Detailed Description
Patients with preoperative anemia have a poorer perioperative outcome in morbidity and mortality as part of surgery. Oral iron preparations have so far had poor bioavailability (approx. 30%) and mostl...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- In the case of conspicuous base laboratory towards undiagnosed hemochromatosis: increased plasma iron, increased serum ferritin and increased transferrin saturation without increased signs of inflammation (CRP), the patient is assigned to the hematological department of the Hanusch Hospital for further diagnosis.
- Acutely therapeutic anemia Hb x 8 g/dl (indication for a mandatory correction of the Hb to a clinically safe or non-therapeutic value - no randomization into the control group makes sense)
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2022
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04351607
Start Date
October 1 2019
End Date
October 1 2022
Last Update
April 17 2020
Active Locations (1)
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1
Department of Anestesiology and Critical Care Medicine
Vienna, Penzing, Austria, 1140