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

NCT ID: NCT04475887

Last Updated: 2020-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-23

Study Completion Date

2023-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Liver Transplantation Blood Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group A

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

Group Type ACTIVE_COMPARATOR

Iron Carboxymaltose

Intervention Type DRUG

see above

Group B

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

see above

Interventions

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Iron Carboxymaltose

see above

Intervention Type DRUG

Placebo

see above

Intervention Type DRUG

Other Intervention Names

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IRON

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Georg Gyoeri

Head of Liver Transplantation Outpatient Clinic

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Georg P Gyoeri, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Surgery

David M Baron, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anaesthesiology

Locations

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Medical University of Vienna, Department of Surgery

Vienna, , Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Georg P Gyoeri, MD

Role: CONTACT

+43140400 ext. 68700

Andreas Rosenstingl

Role: CONTACT

+43140400 ext. 68730

Facility Contacts

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Georg Gyoeri, MD

Role: primary

+43140400 ext. 68700

Andreas Rosenstingl

Role: backup

+43140400 ext. 68730

Other Identifiers

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1175/2017

Identifier Type: -

Identifier Source: org_study_id

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