Setting, study design, and oversight
FVL, trauma
DEL
This double-blind, randomized, placebo-controlled trial was conducted at Fundación Valle del Lili (FVL) University hospital between November 2015 and August 2018. The FVL is a fourth-level university hospital equivalent to a US-level I trauma center, and it has 523 beds. Of these, 205 are ICU beds and 10 are reserved for trauma patients. The FVL trauma center admits approximately 700 moderate-to-severe trauma patients per year, serving as one of the largest trauma referral centers in the southwest region of Colombia.The trial protocol was registered in clinicaltrials.gov (identifier: NCT02542241). The protocol was designed by the Trial Steering Committee and was reviewed and approved by the FVL ethical and biomedical research committee. Written informed consent was obtained from all patients or another surrogate decision-maker. Consent by an independent physician and deferred consent was used as a surrogate to subject consent when appropriate. In these cases, the trial team performed the randomization following pre-specified trial protocol criteria and then requested for the patient’s or representative’s (proxy) informed consent in a later phase.An independent committee and the staff from the FVL clinical research center regularly monitored the trial to check for protocol compliance and data transparency.