Randomized controlled trials: Informing clinical practice for traumatically injured patients

Abstract

Well-designed randomized controlled trials have changed trauma resuscitation dramatically over the past few decades. Randomized controlled trials have established the effectiveness of permissive hypotension and the use of balanced blood product resuscitation to minimize mortality in traumatically injured patients. Together, these therapeutic concepts are termed "damage control resuscitation" and are now the standard of care for traumatically injured patients at risk of hemorrhagic shock and therefore trauma-induced coagulopathy. In order to inform and change clinical practice, experimental human trials require special consideration. Each trial must be created with the safety of participants in mind. The clinical research team is responsible for establishing a trial design and statistical analysis plan which tests a question or hypothesis with scientific value and validity. To respect the trial participants and inform clinical practice, all trial planning, analysis, and outcomes must be reported appropriately both prior to data collection and at the completion of the trial. Therefore, only trials that are carefully and ethically designed, implemented, and analyzed which are adequately and transparently reported should be used to modify norms of clinical practice.