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Open Access Study protocol

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 protocol for a randomized controlled trial

Daniel Reim12, Young-Woo Kim1*, Byung Ho Nam3, Mi-Jung Kim1, Jeong Hwan Yook5, Young Kyu Park6, Sung Hoon Roh7, Wan Sik Yu8 and Jae Moon Bae4*

Author Affiliations

1 Gastric Cancer Branch, Research Institute & Hospital, National Cancer Center, 323 Ilsan-Ro, Ilsandong-Gu, Goyang-si, Gyeonggi-do 411-769, Republic of Korea

2 Department of Surgery, Klinikum Rechts der Isar der Technischen Universität München, Ismaninger Strasse 22, 81675 Munich, Germany

3 National Cancer Center, Biometric Research Branch, Research Institute for National Cancer Control & Evaluation, 323 Ilsan-Ro, Ilsandong-gu, Goyang-si, Gyeonggi-do 411-764, Republic of Korea

4 Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-Ro, Gangnam-gu, Seoul 135-710, Republic of Korea

5 Asan Medical Center, 88 Olympic-Ro 43-Gil, Songpa-gu, Seoul 138-736, Republic of Korea

6 Chonnam National University Hwasun Hospital, 322 Seoyang-Ro Hwasun-Eup, Hwasun-Gun, Jeonnam 519-763, Republic of Korea

7 Yonsei University Health System Severance Hospital, 50 Yonsei-Ro, Seodaemun-gu, Seoul 120-752, Republic of Korea

8 Gastric Cancer Center, Kyungpook National University Medical Center, 807 Hogukno, Buk-gu, Daegu 702-210, Republic of Korea

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Trials 2014, 15:111  doi:10.1186/1745-6215-15-111

Published: 5 April 2014

Abstract

Background

Isovolemic 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 design

Gastric 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.

Discussion

Correction 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 registration

NCT01725789 (international: http://www.clinicaltrials.gov webcite) and NCCCTS-12-644 (NCC, Korea).

Keywords:
Ferric carboxymaltose; Isovolemic postoperative anemia; Gastric cancer; Randomized controlled trial