Treatment of Anemia With Intravenous Iron in Patients Listed for Orthotopic Liver Transplantation

Phase 4

• Conditions: Blood Loss; Liver Transplantation
• Interventions: Drug: Placebo; Drug: Iron Carboxymaltose

• Registration Number: NCT04475887
• Lead Sponsor: Medical University of Vienna

Brief Summary

The aim of this study is to investigate whether therapy with intravenous iron carboxymaltose in patients with iron deficiency anemia (IDA) listed for orthotopic liver transplantation (OLT) increases hemoglobin concentrations and reduces intraoperative transfusion of packed red blood cells (PRBCs). The investigators hypothesize that therapy with intravenous iron will increase hemoglobin concentrations and reduce intraoperative transfusion of PRBCs in patients with IDA listed for OLT.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-07
• Study First Submitted: 2020-07-14
• Study First Submitted QC: 2020-07-16
• Study First Posted: 2020-07-17
• Study Start: 2020-07-23
• Last Update Submitted: 2020-07-24
• Last Update Posted: 2020-07-28
• Primary Completion: 2022-12-31
• Study Completion: 2023-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• patients listed for OLT with positive screening for IDA

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
• Sepsis or severe infection
• Immunosuppressive therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Placebo	IV administration of 1000ml 0.9% NaCl every 4 weeks.
Group A	Iron Carboxymaltose	IV administration of iron-III-carboxymaltose according to iron deficit every 4 weeks.

Primary Outcome Measures

Name	Time	Method
Hemoglobin at OLT	6 months	Change in hemoglobin concentrations from baseline until before induction of anesthesia for OLT

Secondary Outcome Measures

Name	Time	Method
Transfusion requirement	6 months	Transfusion of PRBCs during and within the first 24 hours following OLT
Hemoglobin after 4 weeks	4 weeks	Change in hemoglobin concentrations from baseline until 4 weeks after initiation of therapy

Trial Locations

Locations (1)

Medical University of Vienna, Department of Surgery; 🇦🇹 Vienna, Austria