Anemia, Pancreatic Cancer
Conditions
Keywords
ferric carboxymaltose, Ferinject®, pancreatoduodenectomy
Brief summary
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
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.
Interventions
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.
Sponsors
JW Pharmaceutical
National Cancer Center, Korea
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative transfusion rate | from preoperative baseline within the first 7 days after surgery | To evaluate reducing transfusion rate during perioperative period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of complications after surgery as assessed by Clavien-Dindo classification of surgical complications | up to 4-6 weeks after surgery | To investigate the association between the number of participants with complications and hospital length of stay(days) |
| Change of hematology parameters | up to 4-6 weeks after surgery | change of hematology parameters value of Hb in g/dL, * ferritin in ng/ml * transferrin saturation in % (TSAT) after Ferinject® administration) |
| Adverse event | up to 4-6 weeks after surgery | assessment of adverse effect with Ferinject® administration |
Countries
South Korea
Outcome results
None listed