Verma Kushagra, Kohan Eitan, Ames Christopher P, Cruz Dana L, Deviren Vedat, Berven Sigurd, Errico Thomas J
University of California - San Francisco, San Francisco, CA.
Washington University in St. Louis, St. Louis, MO.
Int J Spine Surg. 2015 Nov 19;9:65. doi: 10.14444/2065. eCollection 2015.
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.
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.
多节段脊柱融合术通常伴随着大量失血。先前的研究表明，抗纤溶药物可减少青少年和成人脊柱畸形患者的失血量。虽然其他亚专业领域也有类似情况，但氨甲环酸（TXA）的剂量仍存在很大差异。迄今为止，在脊柱手术乃至骨科手术中，指导TXA剂量的资料仍然匮乏。
方法/设计：来自3家机构的150名患者（每家机构50名）将被连续纳入研究，并随机分为高剂量TXA组（50mg/kg负荷剂量，随后每小时20mg/kg）或低剂量组（10mg/kg，然后每小时1mg/kg）。外科医生和患者均对治疗组情况不知情。主要结局指标将是围手术期失血量、引流量和输血率。次要结局指标将是住院时间、并发症和总体费用。
本研究的主要目标是为成人脊柱畸形手术中两种TXA给药方案提供一级比较数据。控制失血仍然是减少脊柱畸形手术并发症的关键因素。无效假设是高剂量和低剂量TXA在任何主要或次要结局方面均无差异。
