Clinical trial NCT02628860: Efficacy of Ferric Carboxymaltose (Ferinject®) in Anemic Patients Anticipating Pancreatoduodenectomy
Official title: Efficacy of Ferric Carboxymaltose (Ferinject®) in Anemic Patients Anticipating Pancreatoduodenectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Cancer
Anemia
Keywords: ferric carboxymaltose
Ferinject®
pancreatoduodenectomy
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
Collaborators: name: JW Pharmaceutical
First posted: 2015-12-11
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Perioperative transfusion rate
timeFrame: from preoperative baseline within the first 7 days after surgery
Secondary outcomes:
measure: Assessment of complications after surgery as assessed by Clavien-Dindo classification of surgical complications
timeFrame: up to 4-6 weeks after surgery
measure: Change of hematology parameters
timeFrame: up to 4-6 weeks after surgery
measure: Adverse event
timeFrame: up to 4-6 weeks after surgery
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi
Study officials:
affiliation: Study Principal Investigator
name: Sang Jae Park, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Park SJ, Kim SW, Jang JY, Lee KU, Park YH. Intraoperative transfusion: is it a real prognostic factor of periampullary cancer following pancreatoduodenectomy? World J Surg. 2002 Apr;26(4):487-92. doi: 10.1007/s00268-001-0254-6. Epub 2002 Feb 4.
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citation: Ghio M, Contini P, Mazzei C, Brenci S, Barberis G, Filaci G, Indiveri F, Puppo F. Soluble HLA class I, HLA class II, and Fas ligand in blood components: a possible key to explain the immunomodulatory effects of allogeneic blood transfusions. Blood. 1999 Mar 1;93(5):1770-7.
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