Journal article
Prospective, randomized, controlled, double-blind, multi-center, multinational study on the safety and efficacy of 6% Hydroxyethyl starch (HES) sOlution versus an Electrolyte solutioN In patients undergoing eleCtive abdominal Surgery: study protocol for the PHOENICS study
Abstract
BackgroundHydroxyethyl starch (HES) solutions are used for volume therapy to treat hypovolemia due to acute blood loss and to maintain hemodynamic stability. This study was requested by the European Medicines Agency (EMA) to provide more evidence on the long-term safety and efficacy of HES solutions in the perioperative setting.MethodsPHOENICS is a randomized, controlled, double-blind, multi-center, multinational phase IV (IIIb) study with two …
Authors
Buhre W; de Korte-de Boer D; de Abreu MG; Scheeren T; Gruenewald M; Hoeft A; Spahn DR; Zarbock A; Daamen S; Westphal M
Journal
Trials, Vol. 23, No. 1,
Publisher
Springer Nature
Publication Date
December 2022
DOI
10.1186/s13063-022-06058-6
ISSN
1468-6708