Abstract

BACKGROUND Oral bleeding after dental extraction in patients on non-vitamin K oral anticoagulants (NOACs) is a frequent problem. We investigated whether 10% tranexamic acid (TXA) mouthwash decreases post-extraction bleeding in patients treated with NOACs. METHODS AND FINDINGS The EXTRACT-NOAC study is a randomized, double-blind, placebo-controlled, multicenter, clinical trial. Patients were randomly assigned to 10% TXA or placebo mouthwash and were instructed to use the mouthwash prior to dental extraction, for 3 times a day for 3 days thereafter. The primary outcome was the number of patients with any post-extraction oral bleeding up to day 7. Secondary outcomes included the periprocedural, early, and delayed bleeding, and the safety outcomes included all thrombotic events. The first patient was randomized on February 9, 2018 and the last patient on March 12, 2020. Of 222 randomized patients, 218 patients were included in the full analysis set, of which 106 patients were assigned to TXA (74.8 (±8.8) years; 81 men) and 112 to placebo (72.7 (±10.7) years; 64 men). Post-extraction bleeding occurred in 28 (26.4%) patients in the TXA group and in 32 (28.6%) patients in the placebo group (relative risk, 0.92; 95% confidence interval [CI], 0.60 to 1.42; P = 0.72). There were 46 bleeds in the TXA group and 85 bleeds in the placebo group (rate ratio, 0.57; 95% CI, 0.31 to 1.05; P = 0.07). TXA did not reduce the rate of periprocedural bleeding (bleeding score 4 ± 1.78 versus 4 ± 1.82, P = 0.80) and early bleeding (rate ratio, 0.76; 95% CI, 0.42 to 1.37). Delayed bleeding (rate ratio, 0.32; 95% CI, 0.12 to 0.89) and bleeding after multiple extractions (rate ratio, 0.40; 95% CI, 0.20 to 0.78) were lower in the TXA group. One patient in the placebo group had a transient ischemic attack while interrupting the NOAC therapy in preparation for the dental extraction. Two of the study limitations were the premature interruption of the trial following a futility analysis and the assessment of the patients' compliance that was based on self-reported information during follow-up. CONCLUSIONS In patients on NOACs undergoing dental extraction, TXA does not seem to reduce the rate of periprocedural or early postoperative oral bleeding compared to placebo. TXA appears to reduce delayed bleeds and postoperative oral bleeding if multiple teeth are extracted. TRIAL REGISTRATION ClinicalTrials.gov NCT03413891 EudraCT; EudraCT number:2017-001426-17; EudraCT Public website: eudract.ema.europa.eu.

Abstract

Objective: To compare the effectiveness of tranexamic acid (TXA) in reducing blood loss and decreasing surgery duration in craniomaxillofacial surgery. Methods: The literature was searched systematically for all comparative studies of the effect of TXA on craniomaxillofacial surgery with placebo to evaluate the efficacy of TXA in craniomaxillofacial surgery. The primary outcome was intraoperative blood loss, and secondary outcomes were postoperative hematocrit, postoperative hemoglobin, and operation duration. Results: This systematic review included 16 studies consisting of 958 patients. Meta-analysis revealed that compared with the placebo group, the TXA group showed a significant reduction in intraoperative blood loss of 139.81 mL (95% confidence interval, CI: -179.66 to -99.96 mL; p < 0.01), a shortening of the maxillary surgery duration of 15.48 min (95% CI: -21.03 to -9.92 min; p < 0.01), an elevation of the postoperative hemoglobin level of 0.74 mg/dL (95% CI: 0.42 to 1.07 mg/dL; p < 0.01), and a limited effect on increasing the postoperative hematocrit level of 1.77% (95% CI: 0.17 to 3.36; p = 0.03). Conclusion: The use of TXA in craniomaxillofacial surgery can effectively reduce intraoperative blood loss, maintain elevate postoperative hemoglobin and hematocrit levels, and reduce the operation duration.

Abstract

Orthognathic surgery can cause substantial bleeding. Recent meta-analyses concluded that there is a statistically significant reduction in perioperative blood loss with the preventive use of tranexamic acid (TA). However, the mean reported difference in bleeding was moderate, and the clinical relevance of this blood-sparing effect remains debated. We therefore conducted a prospective, double-blind, randomized, placebo-controlled equivalence study of the effect of TA in patients undergoing Lefort I or bimaxillary osteotomies. Our main outcome measure was total blood loss on postoperative day 1. The equivalence margin was ± 250 ml for the difference in blood loss and its 95% confidence interval. One hundred and forty-seven patients were randomized, of which 122 underwent bimaxillary osteotomies. Blood loss in the treatment group was 682 ± 323 vs. 875 ± 492 ml. The mean difference in bleeding was -132 [-243; -21] ml as per-protocol, but -193 [-329; -57] ml in intention-to-treat: the limits of this confidence interval exceeded the margin of equivalence. Similar results were obtained when analysing only patients undergoing bimaxillary osteotomy. Haemoglobin decreased by 1.8 ± 1.2 g/dl with TA, vs. 2.6 ± 1.1 g/dl with placebo (p<0.001). Our study did not demonstrate equivalence between TA and placebo on perioperative blood loss in orthognathic surgery. TA may reduce blood loss but without evidence of clinical consequences.

Abstract

BACKGROUND Tranexamic acid (TXA) reduces blood loss and transfusion requirements during craniosynostosis surgery in small children. Possible interaction from TXA on the inflammatory system is unknown. OBJECTIVE To evaluate the effect of TXA on a wide range of inflammatory markers in children receiving TXA in a randomized, blinded and placebo controlled study design. METHODS Thirty children undergoing craniosynostosis surgery with significant blood loss received TXA (bolus dose of 10 mg kg(-1) followed by 8 hours continuous infusion of 3 mg kg(-1) h(-1) ) or placebo in a randomized, double-blinded study design. Using a new proximity extension assays employing a panel of inflammatory biomarkers samples was used for analysis of blood samples obtained preoperatively, 4h and 24 h after operation. RESULTS Ninety-two inflammatory parameters were measured. TXA did not affect any of the measured parameters as compared with placebo. Among 34 of the 92 pro- and antiinflammatory parameters investigated changes were observed between preoperative, 4 h or 24 h respectively, reflecting immune activation during surgical stress. CONCLUSION TXA administration in a low-dose regimen including bolus followed by 8h infusion during craniosynostosis surgery did not change any of 92 inflammatory markers as compared with placebo.

Abstract

PURPOSE Little is known of the systemic effects of oral and maxillofacial surgery on the hemostatic balance, including the biochemical effects of tranexamic acid (TXA), on fibrin clot lysis. The present study investigated the effects of orthognathic surgery on fibrin lysis, fibrin structure, and D-dimer and evaluated the effect of TXA on these fibrinolytic measures. MATERIALS AND METHODS The present double-blind, controlled, and randomized, placebo study included patients referred to the Department of Oral and Maxillofacial Surgery at the University Hospital of Southern Denmark-Esbjerg from August 2014 through September 2016. The patients were elective and had a diagnosis of maxillary or mandibular deficiency, either excessive or asymmetric. All patients underwent bimaxillary orthognathic surgery (OS) with or without maxillary segmentation or additional genioplasty. The patients were blindly randomized to treatment with TXA or placebo. The primary predictor variable was OS. The secondary predictor variable was an intravenous dose of 1 g of TXA or equivalent placebo preoperatively. Blood samples were collected before surgery and 5 hours after the initiation of surgery. The primary outcome variable was lysis of fibrin. The fibrin structure properties and D-dimer were secondary outcome measures. The Mann-Whitney U test was used for the within-group comparisons. The Wilcoxon signed rank test was used for the between-group comparisons. RESULTS The sample included 96 patients; 45 had received placebo and 51 had received TXA. Fibrin lysis had decreased after OS (P < .001). The fibrinolytic shutdown had decreased significantly more in the TXA group than in the placebo group (P < .001). OS altered the fibrin structure properties with comparable effects in the 2 groups. D-dimer increased postoperatively but significantly less so in the TXA group than in the control group (P < .001). CONCLUSIONS OS is associated with fibrinolytic shutdown and alters fibrin structure properties, driving the hemostatic balance in a prothrombotic direction. The fibrinolytic shutdown is significantly amplified by TXA.

Abstract

BACKGROUND Tranexamic acid (TXA) is an anti-fibrinolytic agent shown to decrease intraoperative bleeding, reduce transfusions, and improve outcomes across multiple specialties. Within plastic surgery, initial reports are encouraging but formal studies are lacking. A study was designed to assess whether TXA demonstrates noticeable benefit for rhytidectomy to warrant further investigation. OBJECTIVE To determine whether intravenous (IV) TXA has effect on intraoperative bleeding, or postoperative sequelae in patients undergoing a deep-plane facelift. METHODS This is a prospective, randomized, double-blind, case series in a private practice surgery center. Participants included 44 patients undergoing rhytidectomy with the senior authors (R.A.G. or M.J.G). Treatment group received 1 gram of IV TXA prior to skin incision, and 4 hours later (vs saline). Bleeding was rated mild, moderate, or severe. Postoperative ecchymosis and edema were subjectively evaluated by patient and surgeon and scores were aggregated for analysis. RESULTS The TXA group showed decreased intraoperative bleeding but did not reach statistical significance. Postoperative ecchymosis/edema ratings were lower for patients who received TXA, including a statistically significant decrease in surgeon-rated bruising. TXA resulted in a statistically significant decrease in postoperative collections in this study and no major complications occurred. CONCLUSIONS TXA is a safe, low-cost, addition to any existing surgical protocol and may lead to less surgical sequelae and improved satisfaction. Although, we did not observe a dramatically different intraoperative experience, postoperative bruising and collections were significantly reduced. Tranexamic acid may have great value in the management of patients undergoing rhytidectomy and warrants further study.

Abstract

BACKGROUND Tranexamic acid (TXA) is an antifibrinolytic that has become widely used in aesthetic facial plastic surgery, although its efficacy has not been well investigated. OBJECTIVES To evaluate the existing evidence for use of TXA in aesthetic facial plastic surgery, highlighting routes of administration, dosing, surgical applications, and clinical outcomes. METHODS Systematic review of primary literature evaluating TXA in aesthetic facial plastic surgery. RESULTS Eleven studies met inclusion criteria: 8 prospective randomized controlled trials, 2 retrospective case series/cohort studies, and 1 clinical opinion. Six studies evaluated TXA in rhinoplasty, 4 in rhytidectomy, and 1 in blepharoplasty. Significant reductions in intraoperative blood loss were found in 5 rhinoplasty studies. Three rhinoplasty and 2 rhytidectomy studies found significantly reduced postoperative edema and ecchymosis. One rhinoplasty and 1 rhytidectomy study reported reduced operative time and time to achieve hemostasis. One rhytidectomy study reported reduced postoperative drain output and faster time to drain removal. No studies reported an adverse outcome directly related to TXA. CONCLUSIONS Existing literature investigating TXA in aesthetic facial plastic surgery is sparse with varying levels of evidence and heterogeneous data. Literature suggests systemic TXA reduces intraoperative blood loss during rhinoplasty, although the clinical significance of this blood loss reduction is unclear. TXA may also reduce postoperative edema and/or ecchymosis in rhytidectomy and rhinoplasty, although the lack of validated grading scales yields insufficient evidence to support this claim. Topical and subcutaneously injected TXA are emerging administration routes in rhytidectomy, with evidence suggesting TXA mixed with tumescent may reduce postoperative drain output, thereby expediting drain removal.

Abstract

BACKGROUND This scoping review aimed to map available evidence regarding minor/major oral procedures in patients with inherited bleeding disorders (IBDs). METHODS Studies in medicine or dentistry that reported minor and major oral procedures in individuals presenting IBDs (e.g. hemophilia A or B, von Willebrand disease) were selected. Search and screening were performed in PubMed/Medline, Scopus, Web of Science, and Cochrane Library by two independent researchers. RESULTS Initial search yielded 4152 citations, of which 257 were included in the final analysis. Most of the evidence for prophylaxis use was derived from observational studies and the most-commonly reported prophylactic protocols were fresh frozen plasma and factor VIII concentrate. A considerable number of studies reported postoperative complications and hospitalizations. CONCLUSION The present study identified that (1) there is room for new studies to assess the use of antifibrinolytic agents with no factor replacement; (2) to date the use of factor replacement therapy is the most indicated approach when treating patients with IBDs with adjunct systemic or local antifibrinolytic agents to reduce post-operative complications; and (3) there is a critical need for high-quality evidence studies since much of the conclusions of the included studies are not supported by statistical analysis.

Abstract

Background: Tranexamic acid (TXA) has been widely used during craniofacial and orthognathic surgery (OS). However, results of the literature are inconsistent due to specific type of surgery and a small sample of studies. The purpose of this study was to evaluate the role of TXA in bimaxillary OS. Methods: We performed a comprehensive literature search of PubMed, Cochrane Central Register of Controlled Trials, and EMBASE to identify randomized controlled trials (RCTs) that compared effect of TXA on bimaxillary OS with placebo. Outcomes of interests included intraoperative blood loss, allogenic transfusion, operation time, and volume of irrigation fluid. Random effects models were chosen considering that heterogeneity between studies was anticipated, and I (2) statistics were used to test for the presence of heterogeneity. Results: Totally 6 RCTs were identified. Tranexamic acid resulted in significantly reduced intraoperative blood loss (weighted mean difference [WMD] = -264.82 mL; 95% CI: -380.60 to -149.04 mL) and decreased amounts of irrigation fluid (WMD = -229.23 mL; 95% CI: -399.63 to -58.83 mL). However, TXA had no remarkable impact on risk of allogenic blood transfusion (pooled risk ratio = 0.50; 95% CI: 0.20-1.23), operation time (WMD = -8.71 min; 95% CI: -20.98 to 3.57 min), and length of hospital stay (WMD = -0.24 day; 95% CI: -0.62 to 0.14 day). No TXA-associated severe adverse reactions or complications were observed. Conclusions: Currently available meta-analysis reveals that TXA is effective in decreasing intraoperative blood loss; however, it does not reduce the risk of allogenic blood transfusion in bimaxillary OS.

Abstract

PURPOSE In the past, both tranexamic acid and dexmedetomidine have been used separately to decrease intraoperative blood loss during orthognathic surgery. However, their combined use in the same setting has never been prospectively evaluated. The present study was conducted to evaluate the effect of tranexamic acid on operative field visibility and blood loss during orthognathic surgery after dexmedetomidine-induced hypotensive anesthesia. PATIENTS AND METHODS The present prospective, randomized clinical trial included patients who had undergone orthognathic surgery under general anesthesia. The patients were divided into 2 groups. The dexmedetomidine and tranexamic (DT) group received an intravenous bolus of tranexamic acid (15 mg/kg) and intravenous dexmedetomidine (0.25 to 0.7 mug/kg/hr) as maintenance infusion. The dexmedetomidine (DS) group received only intravenous dexmedetomidine at the same dosage. All the patients had received a bolus dose of intravenous dexmedetomidine (1 mug/kg) before the start of anesthesia induction. The operating surgeon rated the quality of the surgical visual field every 15 minutes using the Fromme ordinal scale. Intraoperative blood loss was estimated using the modified gross formula. The operating surgeon's satisfaction was assessed using a Likert scale. Data were analyzed using SPSS, version 22.0 (IBM Corp, Armonk, NY). Kolmogorov-Smirnov tests were used to assess the normality of the measured data, and categorical variables were analyzed using the chi(2) or Fischer exact test. RESULTS The study sample included 36 patients, with a mean age of 23.67 +/- 11.298 years in the DS group and 20.28 +/- 3.286 years in the DT group. Of the patients in the DS and DT groups, 66.66 and 61.11% were male, respectively. No statistically significant differences were found in the baseline characteristics between the 2 treatment groups. The surgeon reported a significantly better surgical visual field in the DT group compared with that in the DS group (P = .001). Also, the intraoperative blood loss significantly less in the DT group (231.11 +/- 137.64 mL vs 360.17 +/- 187.86 mL; P = .025). CONCLUSIONS Tranexamic acid improved surgical field visibility and reduced intraoperative blood loss when administered in conjunction with dexmedetomidine during orthognathic surgery under controlled hypotensive anesthesia.