FAIRY: a randomized controlled patient-blind phase III study to compare the efficacy and safety of intravenous ferric carboxymaltose Ferinject® to placebo in patients with acute isovolemic anemia after gastrectomy - study protocoReport as inadecuate




FAIRY: a randomized controlled patient-blind phase III study to compare the efficacy and safety of intravenous ferric carboxymaltose Ferinject® to placebo in patients with acute isovolemic anemia after gastrectomy - study protoco - Download this document for free, or read online. Document in PDF available to download.

Trials

, 15:111

First Online: 05 April 2014Received: 16 December 2013Accepted: 04 March 2014DOI: 10.1186-1745-6215-15-111

Cite this article as: Reim, D., Kim, YW., Nam, B.H. et al. Trials 2014 15: 111. doi:10.1186-1745-6215-15-111

Abstract

BackgroundIsovolemic anemia decrease in hemoglobin concentration with normal or even increased blood volume after gastric cancer surgery may negatively influence short- and long-term outcomes. Therefore correction of isovolemic postoperative anemia is supposed to be beneficial. This prospective randomized placebo-controlled multicenter trial is designed to evaluate the efficacy of ferric carboxymaltose administration with the primary end point of successful hemoglobin level increase by 2 g-dl at 12 weeks after randomization.

Methods and designGastric cancer patients after oncologic resection and postoperative hemoglobin level ≥ 7 g-dl to <10 g-dl at postoperative days 5 to 7 will be eligible for trial inclusion. After randomization, 450 patients 225 per group are going to be subjected either to administration of ferric carboxymaltose treatment group or normal 0.9% saline placebo group. Patients will be blinded to the intervention. Patients will undergo evaluation for hemoglobin level, hematology and quality of life assessment 3 and 12 weeks after randomization.

DiscussionCorrection of isovolemic postoperative anemia in gastric cancer patients after oncologic resection is considered to be beneficial. Administration of ferric carboxymaltose is considered to be superior to placebo for anemia correction without the possible risks of red blood cell transfusion. Further, improved quality of life for patients with quick recovery of hemoglobin levels is expected.

Trial registrationNCT01725789 international: http:-www.clinicaltrials.gov and NCCCTS-12-644 NCC, Korea.

KeywordsFerric carboxymaltose Isovolemic postoperative anemia Gastric cancer Randomized controlled trial AbbreviationsAEAdverse event

AGCAdvanced gastric cancer

ALTAlanine aminotransferase

ASTAspartate aminotransferase

CRPC-reactive protein

EGCEarly gastric cancer

ESAErythropoiesis stimulating agent

FCMFerric carboxymaltose

FUFluorouracil

GGTGamma-glutamyl transpeptidase

HbHemoglobin

HCGHuman chorionic gonadotropin

IDIron deficiency

IDAIron deficiency anemia

LDHLactate dehydrogenase

OSOverall survival

PFSProgression-free survival

QoLQuality of life

SAESerious adverse event

SUSARSuspected unexpected serious adverse reaction

TSATTranferrin saturation

TIBCTotal iron binding capacity.

Electronic supplementary materialThe online version of this article doi:10.1186-1745-6215-15-111 contains supplementary material, which is available to authorized users.

Young-Woo Kim and Jae Moon Bae contributed equally to this work.

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