Copyright 2015 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.
In Reply Dr Moore and colleagues raise issues regarding clinical trial end points. The 24-hour and 30-day regulatory end points commonly used are based on convenient clock and calendar periods rather than the physiology of patients with severe and multiple injuries at high risk of hemorrhagic death. Regarding potential bias in the determination of hemostasis and death due to exsanguination, these end points were prespecified by investigators as clinically relevant and operationalized to avoid bias. Each death was reviewed by the attending surgeon and then adjudicated by an external clinician blinded to group assignment.
Holcomb JB, Fox EE, Wade CE, . Mortality and Ratio of Blood Products Used in Patients With Severe Trauma—Reply. JAMA. 2015;313(20):2078-2079. doi:10.1001/jama.2015.4427