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

Liver Transplantation Clinical Trial

— TRAILER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04475887
• Other study ID #: 1175/2017
• Status: Recruiting
• Phase: Phase 4
• Start date: July 23, 2020
• Est. completion date: May 31, 2023

Study information

• Verified date: July 2020
• Source: Medical University of Vienna
• Contact: Georg P Gyoeri, MD
• Phone: +43140400
• Email: georg.gyoeri[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Blood Loss
• Liver Transplantation

Intervention

Drug:
• Iron Carboxymaltose
see above
• Placebo
see above

Locations

Country	Name	City	State
Austria	Medical University of Vienna, Department of Surgery	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin at OLT	Change in hemoglobin concentrations from baseline until before induction of anesthesia for OLT	6 months
Secondary	Transfusion requirement	Transfusion of PRBCs during and within the first 24 hours following OLT	6 months
Secondary	Hemoglobin after 4 weeks	Change in hemoglobin concentrations from baseline until 4 weeks after initiation of therapy	4 weeks