Treatment of Anemia With Intravenous Iron in Patients Lis... | NCT04475887

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

NCT04475887

Sponsor

Medical University of Vienna

Status

Unknown status

Last Update Posted

Jul 28, 2020Actual

Enrollment

60Estimated

Phase

Phase 4

Conditions

Liver Transplantation
Blood Loss

Interventions

Iron Carboxymaltose
Placebo

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 23, 2020Actual

Primary Completion Date

Dec 31, 2022Estimated

Completion Date

May 31, 2023Estimated

First Submitted Date

Jul 14, 2020

First Submission Date that Met QC Criteria

Jul 16, 2020

First Posted Date

Jul 17, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 24, 2020

Last Update Posted Date

Jul 28, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Georg Gyoeri, Head of Liver Transplantation Outpatient Clinic, Medical University of ViennaPrincipal Investigator

Lead Sponsor

Medical University of ViennaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Iron Carboxymaltose	Drug	see above	Group A	IRON

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Georg P Gyoeri, MD	Contact	+43140400	68700	georg.gyoeri@meduniwien.ac.at
Andreas Rosenstingl	Contact	+43140400	68730	andreas.rosenstingl@meduniwien.ac.at

Overall Officials

Name	Affiliation	Role
Georg P Gyoeri, MD	Department of Surgery	Principal Investigator
David M Baron, MD	Department of Anaesthesiology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of Vienna, Department of Surgery	Recruiting	Vienna		1090	Austria

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006470	Hemorrhage
D000740	Anemia

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C522335	ferric carboxymaltose
D007501	Iron

Ancestor Terms

ID	Term
D019216	Metals, Heavy
D004602	Elements
D007287	Inorganic Chemicals
D028561	Transition Elements

Browse Leaves

Not provided

Browse Branches

Not provided