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Clinical Trials/EUCTR2017-000703-24-AT
EUCTR2017-000703-24-AT
Active, not recruiting
Phase 1

Treatment of anemia with intravenous iron in patients listed fororthotopic liver transplantation - TRAILER

Medical University of Vienna; Department of Surgery; Division of Transplantation0 sites60 target enrollmentOctober 27, 2017
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DrugsFerinject

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Medical University of Vienna; Department of Surgery; Division of Transplantation
Enrollment
60
Status
Active, not recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 27, 2017
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Medical University of Vienna; Department of Surgery; Division of Transplantation

Eligibility Criteria

Inclusion Criteria

  • •All adult patients with IDA listed for OLT at the Department of Surgery, Division of
  • •Transplantation of the Medical University of Vienna will be evaluated for inclusion into
  • •the study. All patients will have to provide written informed consent before inclusion
  • •into the study.
  • •Following criteria will be used to define IDA:
  • •Hemoglobin (\<12 g/dl) and ferritin (\<30 µg/l)
  • •In case of ferritin levels \>30 µg/l one of the following criteria has to be fulfilled
  • •in addition to hemoglobin levels \<12 g/dl in order to define IDA:
  • •o Serum iron (\<50 µg/dl)
  • •o Transferrin saturation (\<20%)

Exclusion Criteria

  • •Age \<18 years
  • •Hemochromatosis
  • •Iron utilization disorders
  • •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

Outcomes

Primary Outcomes

Not specified

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