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

Medical University of Vienna

Status and phase: Unknown; Phase 4

Conditions: Liver Transplantation; Blood Loss

Treatments: Drug: Iron Carboxymaltose; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04475887

1175/2017

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Group A

Active Comparator group

Description:

IV administration of iron-III-carboxymaltose according to iron deficit every 4 weeks.

Treatment:

Drug: Iron Carboxymaltose

Group B

Placebo Comparator group

Description:

IV administration of 1000ml 0.9% NaCl every 4 weeks.

Treatment:

Drug: Placebo