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

Pancreatic Cancer Clinical Trial

— FCM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02628860
• Other study ID #: NCCCTS-13-709
• Status: Completed
• Phase: Phase 2
• Start date: January 2014
• Est. completion date: April 27, 2020

Study information

• Verified date: April 2020
• Source: National Cancer Center, Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 27, 2020
• Est. primary completion date: April 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Pancreatic Cancer

Intervention

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 . Study drug may be administered as IV drip infusion or IV undiluted bolus injection.

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center	Goyang	Gyeonggi

Sponsors (2)

Lead Sponsor	Collaborator
National Cancer Center, Korea	JW Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (9)

Burrows L, Tartter P. Effect of blood transfusions on colonic malignancy recurrent rate. Lancet. 1982 Sep 18;2(8299):662. — View 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 M — View Citation

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. — View Citation

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 arth — View Citation

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. — View 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. Epub 2002 Feb 4. — View Citation

Peters JH, Carey LC. Historical review of pancreaticoduodenectomy. Am J Surg. 1991 Feb;161(2):219-25. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perioperative transfusion rate	To evaluate reducing transfusion rate during perioperative period	from preoperative baseline within the first 7 days after surgery
Secondary	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
Secondary	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
Secondary	Adverse event	assessment of adverse effect with Ferinject® administration	up to 4-6 weeks after surgery