Randomized controlled trials of aprotinin in cardiac surgery: could clinical equipoise have stopped the bleeding?
Author(s): Fergusson D, Glass KC, Hutton B, Shapiro S Affiliation(s): Ottawa Health Research Institute, Clinical Epidemiology Program, Ottawa, Ontario, Canada. dafergusson@ohri.ca Publication date & source: 2005, Clin Trials., 2(3):218-29; discussion 229-32. Publication type: BACKGROUND: Aprotinin is a serine protease inhibitor used to limit perioperative bleeding and reduce the need for donated blood transfusions during cardiac surgery. Randomized controlled trials of aprotinin evaluating its effect on the outcome of perioperative transfusion have been published since 1987, and systematic reviews were conducted in 1992 and 1997. METHODS: A systematic search was conducted for all RCTs of aprotinin that used placebo controls or were open-label with no active control treatment. Data collected included the primary outcome, objective of each study, whether a systematic review was cited or conducted as part of the background and/or rationale for the study and the number of previously publis