NCT04475887

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2020

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 17, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

July 23, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

July 28, 2020

Status Verified

July 1, 2020

Enrollment Period

2.4 years

First QC Date

July 14, 2020

Last Update Submit

July 24, 2020

Conditions

Liver TransplantationBlood Loss

Keywords

liveranemiatransplantation

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin at OLT

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

    6 months

Secondary Outcomes (2)

  • Transfusion requirement

    6 months

  • Hemoglobin after 4 weeks

    4 weeks

Study Arms (2)

Group A

ACTIVE COMPARATOR

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

Drug: Iron Carboxymaltose

Group B

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Iron CarboxymaltoseDRUG

see above

Also known as: IRON
Group A
PlaceboDRUG

see above

Group B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients listed for OLT with positive screening for IDA

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna, Department of Surgery

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

HemorrhageAnemia

Interventions

ferric carboxymaltoseIron

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsTransition ElementsMetals

Study Officials

  • Georg P Gyoeri, MD

    Department of Surgery

    PRINCIPAL INVESTIGATOR

  • David M Baron, MD

    Department of Anaesthesiology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Georg P Gyoeri, MD

CONTACT

+43140400georg.gyoeri@meduniwien.ac.at

Andreas Rosenstingl

CONTACT

+43140400andreas.rosenstingl@meduniwien.ac.at

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Liver Transplantation Outpatient Clinic

Study Record Dates

First Submitted

July 14, 2020

First Posted

July 17, 2020

Study Start

July 23, 2020

Primary Completion

December 31, 2022

Study Completion

May 31, 2023

Last Updated

July 28, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)