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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
- Source :
- Trials, TRIALS(15)
- Publisher :
- Springer Nature
-
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
- Subjects :
- Male
medicine.medical_specialty
Randomization
Time Factors
Anemia
medicine.medical_treatment
Medicine (miscellaneous)
Placebo
Ferric Compounds
law.invention
Hemoglobins
Study Protocol
Randomized controlled trial
Clinical Protocols
law
Gastrectomy
Stomach Neoplasms
Multicenter trial
Republic of Korea
Clinical endpoint
medicine
Humans
Pharmacology (medical)
Infusions, Intravenous
Maltose
Blood Volume
Isovolemic postoperative anemia
business.industry
Ferric carboxymaltose
Gastric cancer
medicine.disease
Surgery
Clinical trial
Treatment Outcome
Research Design
Hematinics
Quality of Life
Female
business
Biomarkers
Subjects
Details
- Language :
- English
- ISSN :
- 17456215
- Volume :
- 15
- Issue :
- 1
- Database :
- OpenAIRE
- Journal :
- Trials
- Accession number :
- edsair.doi.dedup.....94ccc11155ec648383d666d7ec0ce006
- Full Text :
- https://doi.org/10.1186/1745-6215-15-111