Clinical trial · Interventional
Efficacy of Ferric Carboxymaltose (Ferinject®) in Anemic Patients Anticipating Pancreatoduodenectomy
NCT02628860CI-TRIAL-00044871FCMcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase II study is to evaluate the safety and efficacy of Ferinject® in reducing perioperative transfusion in iron deficiency anemia patients anticipating pancreatoduodenectomy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anemia | — | UNRESOLVED | — |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ferinject (Ferric Carboxymaltose) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ferinject
- description
- 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.
- interventionNames
- Drug: Ferinject (Ferric Carboxymaltose)
Primary outcomes (1)
- measure
- Perioperative transfusion rate
- timeFrame
- from preoperative baseline within the first 7 days after surgery
- description
- To evaluate reducing transfusion rate during perioperative period
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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
References
Publications (9)
- RESULTPark 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. PMID 11910485
- RESULTYeh 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. PMID 17330243
- RESULTPeters JH, Carey LC. Historical review of pancreaticoduodenectomy. Am J Surg. 1991 Feb;161(2):219-25. doi: 10.1016/0002-9610(91)91134-5. PMID 1990875
- RESULTKaplan 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. PMID 6234037
- RESULTWaymack 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. PMID 3492188
- RESULTInnerhofer 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. PMID 10924610
- RESULTGhio 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.