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

Primary Purpose

Liver Transplantation, Blood Loss

Status
Unknown status
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Iron Carboxymaltose
Placebo
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Transplantation focused on measuring liver, anemia, transplantation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Medical University of Vienna, Department of SurgeryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Group A

Group B

Arm Description

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

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

Outcomes

Primary Outcome Measures

Hemoglobin at OLT
Change in hemoglobin concentrations from baseline until before induction of anesthesia for OLT

Secondary Outcome Measures

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

Full Information

First Posted
July 14, 2020
Last Updated
July 24, 2020
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT04475887
Brief Title
Treatment of Anemia With Intravenous Iron in Patients Listed for Orthotopic Liver Transplantation
Acronym
TRAILER
Official Title
Treatment of Anemia With Intravenous Iron in Patients Listed for Orthotopic Liver Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 23, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
May 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Transplantation, Blood Loss
Keywords
liver, anemia, transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
IV administration of iron-III-carboxymaltose according to iron deficit every 4 weeks.
Arm Title
Group B
Arm Type
Placebo Comparator
Arm Description
IV administration of 1000ml 0.9% NaCl every 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Iron Carboxymaltose
Other Intervention Name(s)
IRON
Intervention Description
see above
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
see above
Primary Outcome Measure Information:
Title
Hemoglobin at OLT
Description
Change in hemoglobin concentrations from baseline until before induction of anesthesia for OLT
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Transfusion requirement
Description
Transfusion of PRBCs during and within the first 24 hours following OLT
Time Frame
6 months
Title
Hemoglobin after 4 weeks
Description
Change in hemoglobin concentrations from baseline until 4 weeks after initiation of therapy
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Georg P Gyoeri, MD
Phone
+43140400
Ext
68700
Email
georg.gyoeri@meduniwien.ac.at
First Name & Middle Initial & Last Name or Official Title & Degree
Andreas Rosenstingl
Phone
+43140400
Ext
68730
Email
andreas.rosenstingl@meduniwien.ac.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georg P Gyoeri, MD
Organizational Affiliation
Department of Surgery
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David M Baron, MD
Organizational Affiliation
Department of Anaesthesiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna, Department of Surgery
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georg Gyoeri, MD
Phone
+43140400
Ext
68700
Email
georg.gyoeri@meduniwien.ac.at
First Name & Middle Initial & Last Name & Degree
Andreas Rosenstingl
Phone
+43140400
Ext
68730
Email
Andreas.rosenstingl@meduniwien.ac.at

12. IPD Sharing Statement

Plan to Share IPD
No

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

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