Dhwani Hariharan1, Marco Mammi2,3, Kelicia Daniels1, Nayan Lamba2, Kerilyn Petrucci1, Christian D Cerecedo-Lopez2, Joanne Doucette1, Alexander F C Hulsbergen2, Stefania Papatheodorou4, Linda S Aglio2,5, Timothy R Smith2, Rania A Mekary6,7, Hasan Zaidi2. 1. School of Pharmacy, MCPHS University, Boston, MA, 02115, USA. 2. Department of Neurosurgery, Computational Neuroscience Outcomes Center, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. 3. Neurosurgery Unit, Neuroscience Department, University of Turin, Turin, Italy. 4. Department of Epidemiology, Harvard TH Chan School of Public Health, Boston, MA, USA. 5. Department of Anesthesiology, Perioperative and Pain Management, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. 6. School of Pharmacy, MCPHS University, Boston, MA, 02115, USA. rania.mekary@channing.harvard.edu. 7. Department of Neurosurgery, Computational Neuroscience Outcomes Center, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. rania.mekary@channing.harvard.edu.
Abstract
OBJECTIVES: Major spinal corrective surgeries can be associated with critical intra-operative blood loss. The objective of this systematic review and meta-analysis was to assess the safety and efficacy of tranexamic acid (TXA), a commonly used antifibrinolytic agent, in adult spinal deformity (ASD) surgery, defined as fusion of five or more levels. METHODS: Articles from PubMed, Embase, Cochrane, and clinicaltrials.gov were screened using PRISMA guidelines through December 2018. Thromboembolic events, blood loss, and transfusion levels were primary outcomes of interest. Randomized controlled trials (RCTs) and observational studies (OBSs) with adult patients (≥ 18 years) were included. Continuous variables were analyzed using mean difference (MD) and categorical variables were analyzed using Peto odds ratio (OR), via random effects models. RESULTS: Of the 604 articles screened, seven studies (two RCTs and five cohort studies) were included. Incidence of thromboembolic events was not statistically significantly different between TXA (1 event/19) and placebo (0 events/13) in the RCT (Peto OR = 1.41, 95% CI 0.05-37.2; 32 patients; 1 study) and in the OBSs (TXA [2 events/135] vs control [0 events/72]; Peto OR = 1.09, 95% CI 0.16-7.61; p-heterogeneity = 0.85; 207 patients; 3 studies). Data from OBSs showed that the pooled MD was statistically significantly lower in the TXA group compared with the control group for intraoperative blood loss (MD: - 620.2 mL, 95% CI - 1066.6 to - 173.7; p-heterogeneity = 0.14; 228 patients; 4 studies) and total transfusion volume (MD: - 958.2 mL, 95% CI - 1867.5 to - 49.0; p-heterogeneity = 0.23; 93 patients; 2 studies). CONCLUSION: In this meta-analysis, TXA was not significantly associated with increased risk of thromboembolic events but was associated with lower intraoperative blood loss and lower total transfusion volumes in ASD surgery.
OBJECTIVES: Major spinal corrective surgeries can be associated with critical intra-operative blood loss. The objective of this systematic review and meta-analysis was to assess the safety and efficacy of tranexamic acid (TXA), a commonly used antifibrinolytic agent, in adult spinal deformity (ASD) surgery, defined as fusion of five or more levels. METHODS: Articles from PubMed, Embase, Cochrane, and clinicaltrials.gov were screened using PRISMA guidelines through December 2018. Thromboembolic events, blood loss, and transfusion levels were primary outcomes of interest. Randomized controlled trials (RCTs) and observational studies (OBSs) with adult patients (≥ 18 years) were included. Continuous variables were analyzed using mean difference (MD) and categorical variables were analyzed using Peto odds ratio (OR), via random effects models. RESULTS: Of the 604 articles screened, seven studies (two RCTs and five cohort studies) were included. Incidence of thromboembolic events was not statistically significantly different between TXA (1 event/19) and placebo (0 events/13) in the RCT (Peto OR = 1.41, 95% CI 0.05-37.2; 32 patients; 1 study) and in the OBSs (TXA [2 events/135] vs control [0 events/72]; Peto OR = 1.09, 95% CI 0.16-7.61; p-heterogeneity = 0.85; 207 patients; 3 studies). Data from OBSs showed that the pooled MD was statistically significantly lower in the TXA group compared with the control group for intraoperative blood loss (MD: - 620.2 mL, 95% CI - 1066.6 to - 173.7; p-heterogeneity = 0.14; 228 patients; 4 studies) and total transfusion volume (MD: - 958.2 mL, 95% CI - 1867.5 to - 49.0; p-heterogeneity = 0.23; 93 patients; 2 studies). CONCLUSION: In this meta-analysis, TXA was not significantly associated with increased risk of thromboembolic events but was associated with lower intraoperative blood loss and lower total transfusion volumes in ASD surgery.
Authors: Christine R Baldus; Keith H Bridwell; Lawrence G Lenke; Gbolahan O Okubadejo Journal: Spine (Phila Pa 1976) Date: 2010-01-15 Impact factor: 3.468