Treatment of anemia (low red blood cells) with iron infusions in patients listed for a liver transplantatio

Phase 1

• Conditions: iron deficiency anemia; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2017-000703-24-AT
• Lead Sponsor: Medical University of Vienna; Department of Surgery; Division of Transplantation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-27
• Last Update Posted: 8 April 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

All adult patients with IDA listed for OLT at the Department of Surgery, Division of
Transplantation of the Medical University of Vienna will be evaluated for inclusion into
the study. All patients will have to provide written informed consent before inclusion
into the study.
Following criteria will be used to define IDA:
• Hemoglobin (<12 g/dl) and ferritin (<30 µg/l)
• In case of ferritin levels >30 µg/l one of the following criteria has to be fulfilled
in addition to hemoglobin levels <12 g/dl in order to define IDA:
o Serum iron (<50 µg/dl)
o Transferrin saturation (<20%)
o Mean corpuscular hemoglobin (<27 pg)
o Mean corpuscular volume (<80 fl)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

• Age <18 years
• 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
• female patients breastfeeding
• Sepsis or severe infection
• Immunosuppressive therapy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified