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Purpose: The purpose of this randomized trial was to measure the effect of intravenously administered tranexamic acid (TXA) on intraoperative blood loss (IOB) in patients undergoing bimaxillary orthognathic surgery (OS)., Materials and Methods: The authors designed and implemented a double-blinded placebo-controlled trial composed of patients eligible for OS at the Hospital of South West Denmark (Esbjerg, Denmark) from August 2014 through September 2016. The primary predictor variable was a single intravenous dose of TXA 1 g administered preoperatively or an equivalent saline placebo. The primary outcome was IOB determined by milliliters of blood in the suction canister and gauzes deducted from the volume of saline used intraoperatively., Results: The study population consisted of 96 patients. The TXA group (n = 51) and the placebo group (n = 45) showed a median IOB of 275 and 403 mL (P = .005), respectively. A significant effect of TXA was detected in women (median IOB, 153 mL [96 to 233 mL] in TXA group vs 329 mL [185 to 582 mL] in placebo group; P < .001), whereas no significant effect of TXA on IOB was detected in men (median IOB, 367 mL [275 to 472 mL] in TXA group vs 429 mL [275 to 655 mL] in placebo group; P = .23). No correlations were found between IOB and procedure length, procedure type, or hematologic markers (platelets, hemoglobin, and hematocrit)., Conclusion: In contrast to other studies, this double-blinded randomized controlled trial found a hemostatic effect of TXA in women and none in men who underwent bimaxillary OS. To focus on the specific effect of TXA in men, future studies should include larger male samples., (Copyright © 2017 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.)

Purpose: Bleeding volume in orthognathic surgery (OS) varies considerably, although OS comprises standardized procedures and the patient population consists of young healthy individuals. The aim of this prospective cohort study was to investigate the influence of preoperative sex-related differences in hemostatic parameters on intraoperative bleeding (IOB) volume in OS., Materials and Methods: Patients scheduled for routine OS in our department in Esbjerg, Denmark, were included as study patients in this short-term cohort study. The primary predictor variable was patient sex, and the primary outcome variable was IOB volume measured in milliliters. Secondary outcome variables included preoperative measures of hematologic variables, thromboelastography, fibrinogen concentration, D-dimer concentration, prothrombin fragment 1+2 (F1+2) concentration, and type of osteotomy. Data analyses included the χ(2) test, Mann-Whitney U test, Pearson product moment correlation analysis, and analysis of covariance for analyses of dichotomous variables, comparison between sex, correlations between IOB volume and secondary predictors, and adjustment for confounders, respectively., Results: Forty-one consecutive patients undergoing bimaxillary OS were included and subsequently grouped according to sex (26 men and 15 women). The main finding was that male patients bled twice as much as female patients on average (400 mL [interquartile range, 300 to 500 mL] vs 200 mL [interquartile range, 63 to 288 mL]; P = .001). Age and preoperative measures of thromboelastography, fibrinogen concentration, D-dimer concentration, and F1+2 concentration were significantly associated with sex (P = .001, P = .002, P = .007, and P = .014, respectively). The significant association between sex and IOB volume disappeared when adjusted for these confounders (P = .18)., Conclusions: Preoperative sex-related increases in measures of fibrin turnover predict IOB volume in bimaxillary OS, with women displaying a significantly lower IOB volume than men., (Copyright © 2016 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.)

Purpose: The objective of the present study was to evaluate the efficacy of hemostatic adjuncts on intraoperative blood loss (IOB) in orthognathic surgery (OS) detected by randomized controlled trials (RCTs) of the highest quality., Materials and Methods: A search of the Medline, Cochrane, Embase, and Web of Science databases was performed in January 2015, and the risk of bias was assessed using the Jadad and Delphi scales. The predictor variable was the hemostatic measures, and the main outcome variable was the total IOB volume. The secondary outcome variables were the hemoglobin and hematocrit and operating time. This review is registered at PROSPERO (CRD42014014840)., Results: Eleven trials were included for review. The individual trials demonstrated the effects on IOB from hypotensive anesthetic regimens, the use of aprotinin, and the herbal medicine Yunnan Baiyao. Six studies of tranexamic acid (TXA), with 288 patients, were suitable for a meta-analysis of continuous data. TXA reduced IOB by an average of 171 mL (95% confidence interval [CI] -230 to -112; P < .00001). Its topical use yielded similarly significant results (mean difference -197, 95% CI -319 to -76; P < .001). A subgroup analysis showed a decreased operating time in the TXA groups by an average of 15 minutes (mean difference -14.78, 95% CI -22.21 to -7.35; P < .0001)., Conclusions: Efficient hemostatic adjuncts exist for OS. Our meta-analysis showed that TXA significantly reduces IOB by an average of one third, regardless of whether it was given intravenously (IV) or applied topically. Additional RCTs are needed to confirm the effect of topical TXA in OS, and larger studies of intravenous administration are needed before any routine recommendations. No hemostatic effect of hypotensive anesthesia was found, mainly owing to imprecise descriptions of the blinding procedures. Transparent and uniform trial reporting is thus encouraged in future studies., (Copyright © 2016 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.)

Purpose: The aim of this prospective study was to evaluate the predictive value of the viscoelastic properties of whole blood samples collected preoperatively in relation to intraoperative blood loss in patients subjected to orthognathic surgery., Materials and Methods: Forty-one consecutive patients underwent simultaneous mandibular and maxillary osteotomy. Whole blood samples were collected preoperatively. The intraoperative blood loss volume was precisely estimated. The viscoelastic properties of whole blood samples were evaluated by thromboelastography (TEG), a global method that addresses the complex interplay among coagulation factors, blood platelets, and components of the fibrinolytic system. Blood platelet count, activated partial thromboplastin time, prothrombin time, plasma fibrinogen concentration, and D-dimer concentration were determined by routine methods., Results: Patients were separated into 2 groups according to their intraoperative bleeding volume (≤ 400 mL and >400 mL). No significant associations were observed between routine coagulation tests and intraoperative bleeding volume. The TEG results for the groups were compared. Significant associations were observed between intraoperative blood loss and the clot formation time, maximum clot firmness, and α angle, whereas bleeding volume was not related to the fibrinolytic resistance of the blood clot. An α angle exceeding 67° predicted with 95% certainty a blood loss of 400 mL or less., Conclusions: We conclude that intraoperative bleeding volume in patients subjected to orthognathic surgery can be predicted by means of preoperative TEG analysis. TEG results provide optimization of patient safety and can be used for the evaluation of bleeding risk., (Copyright © 2012 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.)