We appreciate the thoughtful editorial critique provided by Dr Kram1 regarding our recently published report of the effectiveness of a fibrin sealant in controlling hepatic bleeding.2 However, Dr Kram raises several points of concern that require response and clarification. We can only assume that the study design as detailed in the "Patients and Methods" section of the article was incompletely understood when the reviewer states, "This study was purported to be a prospective randomized trial." This was indeed a randomized controlled trial, without qualification. The overall study population consisted of 4 a priori defined surgical subgroups (including hepatic), and randomization was stratified separately within each of these subgroups. Thus, each subgroup constitutes a smaller randomized controlled trial, providing confidence that the individual subgroup findings are valid.3
Chapman WC, Clavien P, Fung JJ, Block JE. Managing Hepatic Bleeding With Autologous Plasma/Collagen-Based Fibrin Sealant. Arch Surg. 2001;136(8):967. doi:
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