Efficacy Of Ferric Carboxymaltose (Ferinject®) In Anemic Patients Anticipating Pancreatoduodenectomy

Study Overview

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

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.

Pancreatic Cancer
Anemia

DRUG: Ferinject (Ferric Carboxymaltose)

NCCCTS-13-709

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2015-02-05	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2020-04-27
First Submitted that Met QC Criteria 2015-12-09	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2020-04-28
First Posted (ACTUAL) 2015-12-11	Results First Posted N/A	Last Verified 2020-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Ferinject 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 .	DRUG: Ferinject (Ferric Carboxymaltose) 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

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Ferinject

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 .

DRUG: Ferinject (Ferric Carboxymaltose)

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

Primary Outcome Measures	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	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
19 Years

Accepts Healthy Volunteers:

≥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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

JW Pharmaceutical

Investigators

PRINCIPAL_INVESTIGATOR: Sang Jae Park, M.D, Study Principal Investigator

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
Yeh JJ, Gonen M, Tomlinson JS, Idrees K, Brennan MF, Fong Y. Effect of blood transfusion on outcome after pancreaticoduodenectomy for exocrine tumour of the pancreas. Br J Surg. 2007 Apr;94(4):466-72. doi: 10.1002/bjs.5488.
Peters JH, Carey LC. Historical review of pancreaticoduodenectomy. Am J Surg. 1991 Feb;161(2):219-25. doi: 10.1016/0002-9610(91)91134-5.
Kaplan J, Sarnaik S, Gitlin J, Lusher J. Diminished helper/suppressor lymphocyte ratios and natural killer activity in recipients of repeated blood transfusions. Blood. 1984 Jul;64(1):308-10.
Waymack JP, Gallon L, Barcelli U, Trocki O, Alexander JW. Effect of blood transfusions on immune function. III. Alterations in macrophage arachidonic acid metabolism. Arch Surg. 1987 Jan;122(1):56-60. doi: 10.1001/archsurg.1987.01400130062009.
Innerhofer P, Tilz G, Fuchs D, Luz G, Hobisch-Hagen P, Schobersberger W, Nussbaumer W, Lochs A, Irschick E. Immunologic changes after transfusion of autologous or allogeneic buffy coat-poor versus WBC-reduced blood transfusions in patients undergoing arthroplasty. II. Activation of T cells, macrophages, and cell-mediated lympholysis. Transfusion. 2000 Jul;40(7):821-7. doi: 10.1046/j.1537-2995.2000.40070821.x.
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.
Burrows L, Tartter P. Effect of blood transfusions on colonic malignancy recurrent rate. Lancet. 1982 Sep 18;2(8299):662. doi: 10.1016/s0140-6736(82)92764-7. No abstract available.
Griffin JF, Smalley SR, Jewell W, Paradelo JC, Reymond RD, Hassanein RE, Evans RG. Patterns of failure after curative resection of pancreatic carcinoma. Cancer. 1990 Jul 1;66(1):56-61. doi: 10.1002/1097-0142(19900701)66:13.0.co;2-6.

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