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

July 24, 2020 updated by: Georg Gyoeri, Medical University of Vienna
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
IV administration of iron-III-carboxymaltose according to iron deficit every 4 weeks.
Drug: Iron Carboxymaltose
see above
Other Names:
  • IRON
Placebo Comparator: Group B
IV administration of 1000ml 0.9% NaCl every 4 weeks.
Drug: Placebo
see above

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Georg P Gyoeri, MD, Department of Surgery
  • Principal Investigator: David M Baron, MD, Department of Anaesthesiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 23, 2020

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

May 31, 2023

Study Registration Dates

First Submitted

July 14, 2020

First Submitted That Met QC Criteria

July 16, 2020

First Posted (Actual)

July 17, 2020

Study Record Updates

Last Update Posted (Actual)

July 28, 2020

Last Update Submitted That Met QC Criteria

July 24, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1175/2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Liver Transplantation

Clinical Trials on Iron Carboxymaltose

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Singapore

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe