NCT02628860

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: National Cancer Center, Korea · Other Government
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreatic Cancer
• Anemia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-01-01
• Primary completion: 2020-04-27
• Completion: 2020-04-27
• First posted: 2015-12-11
• Last updated: 2020-04-28

Locations

1 site across 1 country: South Korea