Treatment of Anemia With Intravenous Iron in Patients Listed for Orthotopic Liver Transplantation
NCT ID: NCT04475887
Last Updated: 2020-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
60 participants
INTERVENTIONAL
2020-07-23
2023-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Group A
IV administration of iron-III-carboxymaltose according to iron deficit every 4 weeks.
Iron Carboxymaltose
see above
Group B
IV administration of 1000ml 0.9% NaCl every 4 weeks.
Placebo
see above
Interventions
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Iron Carboxymaltose
see above
Placebo
see above
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Hemochromatosis
* Iron utilization disorders
* Non-IDA
* Therapy with erythropoietin-stimulating agents or intravenous iron within 4 weeks prior to screening
* Previous allergic reactions against intravenous iron formulations
* Transfusion within 2 weeks prior to screening
* Complete portal vein thrombosis
* High-urgency OLT
* Pregnancy
* Sepsis or severe infection
* Immunosuppressive therapy
18 Years
ALL
No
Sponsors
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Medical University of Vienna
OTHER
Responsible Party
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Georg Gyoeri
Head of Liver Transplantation Outpatient Clinic
Principal Investigators
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Georg P Gyoeri, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Surgery
David M Baron, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Anaesthesiology
Locations
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Medical University of Vienna, Department of Surgery
Vienna, , Austria
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1175/2017
Identifier Type: -
Identifier Source: org_study_id
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