Efficacy of Ferric Carboxymaltose (Ferinject®) in Anemic Patients Anticipating Pancreatoduodenectomy
NCT ID: NCT02628860
Last Updated: 2020-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
40 participants
INTERVENTIONAL
2014-01-31
2020-04-27
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Use of Intravenous Ferric Carboxymaltose in Treatment of Anemia in Cancer Patients Undergoing Chemotherapy
NCT04246021
Improved Recovery by Iron Following Surgery With Blood Loss, the IRIS-trial
NCT05744219
The Study of Huaier Granule in Postoperative Adjuvant Therapy of Resectable Pancreatic Cancer
NCT06368063
Single-arm Clinical Trial of TACE in Combination With Icaritin as Adjuvant Therapy After Surgery in Patients With Hepatocellular Carcinoma at High Risk of Recurrence
NCT06644937
Docetaxel in Combination With Iressa in Previously Treated Patients With Pancreatic Cancer
NCT00137761
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Secondary objectives : Postoperative complication, hospital stay, change of hematological parameters (Hb, ferritin, transferrin saturation (TSAT) change after Ferinject® injection), adverse effect with Ferinject® injection.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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 .
Dosage form: 5% w/v iron containing 50 mg iron per mL, as sterile solution of FERINJECT® in water for injection. In case of drip infusion FERINJECT® must be diluted only in sterile 0.9% sodium chloride.
Strength/Packaging: 10 mL vials containing 500 mg iron as iron per vial.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* anticipating PD
* preoperative Hb of Female 7.0-11.9g/dl and Male 7.0-12.9g/dl
* signed written informed consent
Exclusion Criteria
* 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
19 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
JW Pharmaceutical
INDUSTRY
National Cancer Center, Korea
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Sang-Jae Park
Head of Center for Liver Cancer, Chief of the Liver and Pancreatobiliary Cancer Branch
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sang Jae Park, M.D
Role: PRINCIPAL_INVESTIGATOR
Study Principal Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCCCTS-13-709
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.