Abstract

<h3>BACKGROUND CONTEXT</h3> Postoperative hematoma following lumbosacral surgery carries significant morbidity. Tranexamic acid (TXA) has been shown to mitigate perioperative blood loss in lumbosacral fusion. <h3>PURPOSE</h3> We sought to report a quality improvement (QI) protocol using intravenous (iv) and/or tTXA to reduce postoperative surgical site hematoma (SSH) in patients undergoing elective lumbosacral surgery. <h3>STUDY DESIGN/SETTING</h3> Longitudinal comparative cohort. <h3>PATIENT SAMPLE</h3> Consecutive adults who underwent elective lumbosacral laminectomy and/or fusion in a single institution. <h3>OUTCOME MEASURES</h3> SSH hematoma necessitating evacuation of hematoma or readmission to the hospital due to hematoma. <h3>METHODS</h3> The FADE model was used. A feasibility study was performed in 2019 using IV or tTXA. Retrospective chart review demonstrated preimplementation baseline (7/1/18-6/30/19) SSH rate. Multiple interdisciplinary meetings were conducted to ensure standardized coagulopathy screening, TXA administration, drug supply, and compliance monitoring. Topical TXA was given in 2 g/250 NS via 60mL bulb syringe while ivTXA was given as 1 g bolus over 10 minutes. The QI project was integrated with the residents' patient safety activity. The QI start date was February 2020 with the interim analysis set for June 2020. The primary outcome was postoperative hematoma necessitating evacuation or hospital readmission. The secondary outcome was hospital length of stay. The post-implementation data were collected prospectively. A final analysis was performed for July 2020 - October 2020. Univariate analysis was used to compare outcome measures between pre- and postimplementation populations. A p-value < .05 was considered significant. A sample size calculation determined that there should be 198 patients in each group for a total of 396 patients. <h3>RESULTS</h3> During interim analyses, we found inadequate compliance with tTXA usage (68.5%). Stakeholders were reeducated regarding usage of tTXA and the implementation date was redefined as 7/1/2020. Comparing consecutive lumbosacral surgical patients in pre- (219 patients) and postimplementation (258 patients), the postimplementation group demonstrated significantly reduced incidence of SSH requiring evacuation (.38% vs 3.3%, p<.001) TXA compliance significantly improved after QI implementation (86.8% vs 9.6%, p=.001). The postimplementation tTXA group demonstrated that our standardized protocol resulted in a significantly lower incidence of SSH (.45% vs 4.8%, p=.004). <h3>CONCLUSIONS</h3> Our QI project demonstrated that the use of IV and tTXA was associated with a significantly lower rate of SSH requiring evacuation. We also demonstrated that the use of standardized administration of tTXA was associated with similar benefits when compared with nonstandardized tTXA administration. <h3>FDA DEVICE/DRUG STATUS</h3> tranexamic acid (Investigational/Not Approved)

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