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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04475887

Acronym

TRAILER

Enrollment

Registered

2020-07-17

Start date

2020-07-23

Completion date

2023-05-31

Last updated

2020-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Transplantation, Blood Loss

Keywords

liver, anemia, transplantation

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.

Interventions

DRUGIron Carboxymaltose

see above

DRUGPlacebo

see above

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Hemoglobin at OLT	6 months	Change in hemoglobin concentrations from baseline until before induction of anesthesia for OLT

Secondary

Measure	Time frame	Description
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

Countries

Austria

Contacts

Primary ContactGeorg P Gyoeri, MD

georg.gyoeri@meduniwien.ac.at+43140400

Backup ContactAndreas Rosenstingl

andreas.rosenstingl@meduniwien.ac.at+43140400

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026