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

National Cancer Center, Korea40 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pancreatic Cancer Anemia

Interventions

Ferinject (Ferric Carboxymaltose)DRUG

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.

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Outcomes

Primary Outcomes

Perioperative transfusion rate

To evaluate reducing transfusion rate during perioperative period

Time frame: from preoperative baseline within the first 7 days after surgery

Secondary Outcomes

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)

Time frame: 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)

Time frame: up to 4-6 weeks after surgery

Adverse event

assessment of adverse effect with Ferinject® administration

Time frame: up to 4-6 weeks after surgery

Data from ClinicalTrials.gov

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