Efficacy of Ferric Carboxymaltose (Ferinject®) in Anemic Patients Anticipating Pancreatoduodenectomy

Study Overview
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Brief Summary
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This phase II study is to evaluate the safety and efficacy of Ferinject® in reducing perioperative transfusion in iron deficiency anemia patients anticipating pancreatoduodenectomy.

Detailed Description
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Primary objectives : Perioperative transfusion rate (including preop, intraop, postop≦7 days). Secondary objectives : Postoperative complication, hospital stay, change of hematological parameters (Hb, ferritin, transferrin saturation (TSAT) change after Ferinject® injection), adverse effect with Ferinject® injection.

Official Title
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Efficacy of Ferric Carboxymaltose (Ferinject®) in Anemic Patients Anticipating Pancreatoduodenectomy

Conditions
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Pancreatic Cancer, Anemia

Intervention / Treatment
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* Drug: Ferinject (Ferric Carboxymaltose)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥19 years old anticipating PD preoperative Hb of Female 7.0-11.9g/dl and Male 7.0-12.9g/dl signed written informed consent Exclusion Criteria: a concurrent medical condition(s) that would prevent compliance or participation or jeopardize the health of the patient hypersensitivity to any component of the formulation active severe infection/inflammation history of transfusion, erythropoietin, >500 mg intravenous iron administration within 4 weeks prior to screening. history of acquired iron overload. MCV > 95µm3 or TSAT > 35% patients with preoperative Hb<7 g/dl pregnancy or lactation decreased renal function (defined as creatinine clearance <50 L/min/1.73m2calculated by eGFR(MDRD)) chronic liver disease or increase of liver enzymes (ALT, AST) >5 times the upper limit of normal range

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ferinject<br>Ferinject to be administered as IV drip infusion or undiluted bolus injection with a minimum administration time of 15minutes (for 1000mg single administration) for body weight ≥50 Kg or 6 minutes (for 500mg single administration) for body weight <50 Kg . Dosage form: 5% w/v iron containing 50 mg iron per mL, as sterile solution of FERINJECT® in water for injection. In case of drip infusion FERINJECT® must be diluted only in sterile 0.9% sodium chloride. Strength/Packaging: 10 mL vials containing 500 mg iron as iron per vial. | Drug: Ferinject (Ferric Carboxymaltose)<br>* Ferinject® to be administered as IV drip infusion or undiluted bolus injection with a minimum administration time of 15minutes (for 1000mg single administration) for body weight ≥50 Kg or 6 minutes (for 500mg single administration) for body weight <50 Kg . Study drug may be administered as IV drip infusion or IV undiluted bolus injection.<br>* Other names: Ferinject;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative transfusion rate | To evaluate reducing transfusion rate during perioperative period | from preoperative baseline within the first 7 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of complications after surgery as assessed by Clavien-Dindo classification of surgical complications | To investigate the association between the number of participants with complications and hospital length of stay(days) | up to 4-6 weeks after surgery | 
| Change of hematology parameters | change of hematology parameters value of Hb in g/dL, ferritin in ng/ml transferrin saturation in % (TSAT) after Ferinject® administration) | up to 4-6 weeks after surgery | 
| Adverse event | assessment of adverse effect with Ferinject® administration | up to 4-6 weeks after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ferric carboxymaltose, Ferinject®, pancreatoduodenectomy