BACKGROUND: Multilevel spinal fusions have typically been associated with significant blood loss. Previous studies have shown a reduction in blood loss with antifibrinolytics in both adolescent and adult spinal deformity patients. While this has been mirrored in other subspecialties as well, the dosing of TXA remains highly variable. To date, there remains a paucity of data guiding dosing for TXA in spine surgery and orthopedic surgery as a whole. METHODS/ DESIGN: One hundred and fifty patients from 3 institutions (50 each site) will be consecutively enrolled and randomized to either a high dose of TXA (50mg/kg loading followed by 20mg/kg hourly) or a lose dose (10mg/kg, then 1mg/kg hourly). Both surgeons and patients will be blinded to the treatment group. Primary outcomes will be perioperative blood loss, drain output, and transfusion rate. Secondary outcomes will be length of stay, complications, and overall cost. DISCUSSION: The primary goal of this study is to provide level-1 comparative data for two TXA dosing regimens in adult spinal deformity surgery. Management of blood loss remains a critical factor in reducing complications during spinal deformity surgery. The null hypothesis is that there is no difference between high- and low-dose TXA with respect to any of the primary or secondary outcomes.
RCT Entities:
BACKGROUND: Multilevel spinal fusions have typically been associated with significant blood loss. Previous studies have shown a reduction in blood loss with antifibrinolytics in both adolescent and adult spinal deformitypatients. While this has been mirrored in other subspecialties as well, the dosing of TXA remains highly variable. To date, there remains a paucity of data guiding dosing for TXA in spine surgery and orthopedic surgery as a whole. METHODS/ DESIGN: One hundred and fifty patients from 3 institutions (50 each site) will be consecutively enrolled and randomized to either a high dose of TXA (50mg/kg loading followed by 20mg/kg hourly) or a lose dose (10mg/kg, then 1mg/kg hourly). Both surgeons and patients will be blinded to the treatment group. Primary outcomes will be perioperative blood loss, drain output, and transfusion rate. Secondary outcomes will be length of stay, complications, and overall cost. DISCUSSION: The primary goal of this study is to provide level-1 comparative data for two TXA dosing regimens in adult spinal deformity surgery. Management of blood loss remains a critical factor in reducing complications during spinal deformity surgery. The null hypothesis is that there is no difference between high- and low-dose TXA with respect to any of the primary or secondary outcomes.
Authors: Aryeh Shander; Axel Hofmann; Sherri Ozawa; Oliver M Theusinger; Hans Gombotz; Donat R Spahn Journal: Transfusion Date: 2009-12-09 Impact factor: 3.157
Authors: Christopher M Duncan; Blake P Gillette; Adam K Jacob; Rafael J Sierra; Joaquin Sanchez-Sotelo; Hugh M Smith Journal: J Arthroplasty Date: 2014-09-06 Impact factor: 4.757
Authors: Peter O Newton; Tracey P Bastrom; John B Emans; Suken A Shah; Harry L Shufflebarger; Paul D Sponseller; Daniel J Sucato; Lawrence G Lenke Journal: Spine (Phila Pa 1976) Date: 2012-11-01 Impact factor: 3.468
Authors: Christopher Mikhail; Zach Pennington; Paul M Arnold; Darrel S Brodke; Jens R Chapman; Norman Chutkan; Michael D Daubs; John G DeVine; Michael G Fehlings; Daniel E Gelb; George M Ghobrial; James S Harrop; Christian Hoelscher; Fan Jiang; John J Knightly; Brian K Kwon; Thomas E Mroz; Ahmad Nassr; K Daniel Riew; Lali H Sekhon; Justin S Smith; Vincent C Traynelis; Jeffrey C Wang; Michael H Weber; Jefferson R Wilson; Christopher D Witiw; Daniel M Sciubba; Samuel K Cho Journal: Global Spine J Date: 2020-01-06