Treatment of anemia (low red blood cells) with iron infusions in patients listed for a liver transplantation

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-000703-24-AT

Enrollment

Registered

2017-10-27

Start date

2017-11-17

Completion date

Unknown

Last updated

2024-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

iron deficiency anemia

Interventions

Trade Name: Ferinject Pharmaceutical Form: Solution for infusion INN or Proposed INN: FERRIC CARBOXYMALTOSE CAS Number: 9007-72-1 Concentration unit: mg/ml milligram(s)/millilitre Concentration type:

Eligibility

Sex/Gender

All

Inclusion 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 (30 µg/l one of the following criteria has to be fulfilled in addition to hemoglobin levels =65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

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 • female patients breastfeeding • Sepsis or severe infection • Immunosuppressive therapy

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate whether therapy with intravenous iron in anemic patients listed for orthotopic liver transplantation (OLT) increases hemoglobin concentrations and reduces intraoperative transfusion of packed red blood cells (PRBCs);Secondary Objective: Not applicable;Primary end point(s): - Change in hemoglobin concentrations from baseline until before induction of anesthesia for OLT - Change in hemoglobin concentrations from baseline until 4 weeks after initiation of therapy;Timepoint(s) of evaluation of this end point: 4 weeks after treament start and at timepoint of LTX	—

Measure

Time frame

Main Objective: To investigate whether therapy with intravenous iron in anemic patients listed for orthotopic liver transplantation (OLT) increases hemoglobin concentrations and reduces intraoperative transfusion of packed red blood cells (PRBCs);Secondary Objective: Not applicable;Primary end point(s): - Change in hemoglobin concentrations from baseline until before induction of anesthesia for OLT - Change in hemoglobin concentrations from baseline until 4 weeks after initiation of therapy;Timepoint(s) of evaluation of this end point: 4 weeks after treament start and at timepoint of LTX

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Secondary

Measure	Time frame
Secondary end point(s): - Transfusion of PRBCs during and within the first 24 hours following OLT - Serum iron concentrations, ferritin concentrations, and transferrin saturation before induction of anesthesia - Health-related quality of life (SF36 questionaire) and fatigue (FIS and FSS questionaire). - Transfusion of fresh frozen plasma and platelet concentrates during and within the first 24 hours following OLT - Administration of coagulation products during and within the first 24 hours following OLT - Administration of crystalloid and colloid solutions during and within the first 24 hours following OLT;Timepoint(s) of evaluation of this end point: At timepoint of LTX and 24 hours after LTX	—

Measure

Time frame

Secondary end point(s): - Transfusion of PRBCs during and within the first 24 hours following OLT - Serum iron concentrations, ferritin concentrations, and transferrin saturation before induction of anesthesia - Health-related quality of life (SF36 questionaire) and fatigue (FIS and FSS questionaire). - Transfusion of fresh frozen plasma and platelet concentrates during and within the first 24 hours following OLT - Administration of coagulation products during and within the first 24 hours following OLT - Administration of crystalloid and colloid solutions during and within the first 24 hours following OLT;Timepoint(s) of evaluation of this end point: At timepoint of LTX and 24 hours after LTX

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Countries

Austria

Contacts

Public ContactTransplantation Center

Medical University Vienna

georg.gyoeri@meduniwien.ac.at+43140400-68730

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026