Tranexamic Acid in Craniomaxillofacial Surgery: A Meta-Analysis and Systematic Review
Facial plastic surgery & aesthetic medicine. 2021
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.
Efficacy and Safety of Tranexamic Acid in Bimaxillary Orthognathic Surgery
Plast Surg (Oakv). 2020;28(2):94-104
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.
Tranexamic Acid in Aesthetic Facial Plastic Surgery: A Systematic Review of Evidence, Applications, and Outcomes
Aesthetic surgery journal. Open forum. 2020;2(3):ojaa029
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.
Inherited bleeding disorders in oral procedures. Assessment of prophylactic and therapeutic protocols: a scoping review
Australian dental journal. 2020
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.
The efficacy of tranexamic acid for orthognathic surgery: a meta-analysis of randomized controlled trials
International journal of oral and maxillofacial surgery. 2019
The efficacy of tranexamic acid in orthognathic surgery remains controversial. We conducted a systematic review and meta-analysis to explore the influence of tranexamic acid on blood loss for orthognathic surgery. We performed a search of PubMed, Embase, Web of science, EBSCO, and Cochrane library databases through October 2017 for randomized controlled trials (RCTs) assessing the effects of tranexamic acid versus placebo on orthognathic surgery. Meta-analysis was performed using the random-effects model. Six RCTs were included in the meta-analysis. Overall, compared with placebo in orthognathic surgery, tranexamic acid administration results in significantly decreased blood loss [mean difference (MD)=-159.73; 95% confidence interval (CI)=-236.42 to -83.03; P<0.0001], and higher postoperative haemoglobin (MD=0.71; 95% CI=0.11 to 1.31; P=0.02), but has no remarkable impact on postoperative haematocrit (MD=1.23; 95% CI=-1.22 to 3.69; P=0.33) and operation time (MD=-2.35; 95% CI=-18.05 to 13.36; P=0.77). In addition, patients with orthognathic surgery need decreased amounts of irrigant fluid (MD=-229.23; 95% CI=-399.63 to -58.83; P=0.008) after using tranexamic acid. We concluded that tranexamic acid promotes the bleeding control in orthognathic surgery.
Antifibrinolytic therapy for preventing oral bleeding in patients with haemophilia or Von Willebrand disease undergoing minor oral surgery or dental extractions
The Cochrane database of systematic reviews. 2019;4:Cd011385
BACKGROUND Minor oral surgery or dental extractions (oral or dental procedures) are widely performed and can be complicated by hazardous oral bleeding, especially in people with an inherited bleeding disorder such as haemophilia or Von Willebrand disease (VWD). The amount and severity of singular bleedings depend on disease-related factors, such as the severity of the haemophilia, both local and systemic patient factors (such as periodontal inflammation, vasculopathy or platelet dysfunction) and intervention-related factors (such as the type and number of teeth extracted or the dimension of the wound surface). Similar to local haemostatic measures and suturing, antifibrinolytic therapy is a cheap, safe and potentially effective treatment to prevent bleeding complications in individuals with bleeding disorders undergoing oral or dental procedures. However, a systematic review of trials reporting outcomes after oral surgery or a dental procedure in people with an inherited bleeding disorder, with or without, the use of antifibrinolytic agents has not been performed to date. This is an update of a previously published Cochrane Review. OBJECTIVES Primarily, we aim to assess the efficacy of antifibrinolytic agents to prevent bleeding complications in people with haemophilia or VWD undergoing oral or dental procedures.Secondary objectives are to assess if antifibrinolytic agents can replace or reduce the need for clotting factor concentrate therapy in people with haemophilia or VWD and to establish the effects of these agents on bleeding in oral or dental procedures for each of these patient populations. SEARCH METHODS We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Coagulopathies Trials Register, compiled from electronic database searches of the Cochrane Central Register of Controlled Trials (CENTRAL), of MEDLINE and from handsearching of journals and conference abstract books. We additionally searched the reference lists of relevant articles and reviews. We searched PubMed, Embase, Cinahl and the Cochrane Library. Additional searches were performed in ClinicalTrials.gov, WHO International Clinical Trials Registry Platform (ICTRP).Date of last search of the Cystic Fibrosis and Genetic Disorders Group's Coagulopathies Trials Register: 01 March 2019. SELECTION CRITERIA Randomised and quasi-randomised controlled trials in people with haemophilia or VWD undergoing oral or dental procedures using antifibrinolytic agents (tranexamic acid or epsilon aminocaproic acid (EACA)) to prevent perioperative bleeding compared to no intervention or usual care with or without placebo. DATA COLLECTION AND ANALYSIS Two authors independently screened the titles and abstracts of all identified articles. Full texts were obtained for potentially relevant abstracts and two authors independently assessed these for inclusion based on the selection criteria. A third author verified trial eligibility. Two authors independently performed data extraction and risk of bias assessments using standardised forms. MAIN RESULTS While there were no eligible trials in people with VWD identified, two randomised, double-blind, placebo-controlled trials (total of 59 participants) in people with haemophilia undergoing dental extraction were included. One trial of tranexamic acid published in 1972 included 28 participants with mild, moderate or severe haemophilia A and B and one of EACA published in 1971 included 31 people with haemophilia with factor VIII or factor IX levels less than 15%. Overall, the two included trials showed a beneficial effect of tranexamic acid and EACA, administered systemically, in reducing the number of bleedings, the amount of blood loss and the need for therapeutic clotting factor concentrates. Regarding postoperative bleeding, the tranexamic acid trial showed a risk difference (RD) of -0.64 (95% confidence interval (CI) -0.93 to - 0.36) and the EACA trial a RD of -0.50 (95% CI 0.77 to -0.22). The combined RD of both trials was -0.57 (95% CI -0.76 to -0.37), with the quality of the evidence (GRADE) for this outcome is rated as moderate. Side effects occurred once and required stopping EACA (combined RD of -0.03 (95% CI -0.08 to 0.13). There was heterogeneity between the two trials regarding the proportion of people with severe haemophilia included, the concomitant standard therapy and fibrinolytic agent treatment regimens used. We cannot exclude that a selection bias has occurred in the EACA trial, but overall the risk of bias appeared to be low for both trials. AUTHORS' CONCLUSIONS Despite the discovery of a beneficial effect of systemically administered tranexamic acid and EACA in preventing postoperative bleeding in people with haemophilia undergoing dental extraction, the limited number of randomised controlled trials identified, in combination with the small sample sizes and heterogeneity regarding standard therapy and treatment regimens between the two trials, do not allow us to conclude definite efficacy of antifibrinolytic therapy in oral or dental procedures in people with haemophilia. No trials were identified in people with VWD.
The Role of Antifibrinolytics in Reducing Blood Loss During Craniofacial or Orthognathic Surgical Procedures: A Meta-Analysis
Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons. 2019
PURPOSE Use of antifibrinolytic drugs in craniofacial and orthognathic surgery seems quite promising and has strong advocates. However, supporting evidence is controversial and limited by a small sample of individual studies. We sought to systematically review and meta-analyze the available data regarding the role of preoperative or intraoperative antifibrinolytic drugs (eg, tranexamic acid, aprotinin, or aminocaproic acid) in craniofacial and orthognathic surgery. MATERIALS AND METHODS We searched PubMed, Scopus, Embase, the Cochrane Library, and Web of Science through April 19, 2018, according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Outcomes of interest included the volume of blood loss, volume of transfusions, and operative time. A meta-analysis was performed with a random-effects model using Review Manager (RevMan) software (The Cochrane Collaboration, Copenhagen, Denmark). RESULTS We identified 32 eligible studies with 749 patients undergoing craniofacial surgery and 546 undergoing orthognathic surgery. Meta-analysis showed that antifibrinolytic use led to statistically significant decreases in blood loss and blood transfusions for craniofacial procedures in adult or pediatric patients and to significantly less blood loss during orthognathic surgical procedures. Operative time did not significantly differ for either type of surgery. CONCLUSIONS Antifibrinolytics can significantly reduce blood loss in craniofacial surgical procedures including pediatric craniosynostosis and adult rhinoplasties and in orthognathic surgical procedures, as well as transfusion requirements in pediatric craniofacial surgical procedures. However, the clinical significance of the medications is still questionable because of the relative paucity of information on adverse effects and the usual small volume loss during those operations.
Comprehensive assessment of tranexamic acid during orthognathic surgery: A systematic review and meta-analysis of randomized, controlled trials
Journal of cranio-maxillo-facial surgery : official publication of the European Association for Cranio-Maxillo-Facial Surgery. 2019
The objective of this study was to comprehensively assess the use of tranexamic acid (TXA) during orthognathic surgery. A systematic review and meta-analysis of randomized controlled trials addressing these issues were carried out. Three electronic databases, included PubMed, Web of Science, and Cochrane Library, were searched until April 30, 2018. Eligible studies were restricted to randomized, controlled trials (RCTs). Weighted mean differences (WMD) for blood loss, operation time, haematocrit, quality of surgical field, and odds ratio (OR) for transfusion rates were pooled for the included studies. Eight randomized, controlled trials were included for analysis. Compared with the control group, the TXA group showed a reduction in intraoperative blood loss of 165.03 ml (p < 0.00001; 95% CI, -200.93 to -129.13 ml), a reduction in the drop of haematocrit of 2.32 g/dl (p < 0.00001; 95% CI, -3.38 to -1.26 g/dl), and an improved quality of surgical field (p < 0.00001; MD, -1.01; 95% CI, -1.23 to -0.80). Tranexamic acid has a limited effect on reducing operative time (p < 0.00001; MD, -16.18 min; 95% CI, -19.60 to -12.75 min) and on decreasing the transfusion rates (p = 0.02; OR = 0.33; 95% CI, 0.13 to 0.83).
Role of tranexamic acid in nasal surgery: A systemic review and meta-analysis of randomized control trial
OBJECTIVE Nasal surgeries (such as Functional Endoscopic Sinus Surgery, Rhinoplasty, and Septorhinoplasty) are popular procedures. But perioperative bleeding, eyelid edema, and periorbital ecchymosis remain problems. Tranexamic acid (TXA) is an antifibrinolytic, and it was used to reduce the perioperative bleeding. However, there is no enough evidence judging its safety and efficiency. Therefore, a meta-analysis is conducted by us to evaluate the role of TXA in patients undergoing nasal surgeries. METHOD A search of the literature was performed until June 2018; the PubMed, Embase, Cochrane Central Register of Controlled Trials, and Google Scholar databases were searched for related articles using search strategy. Two authors independently assessed the methodological quality of the included studies and extracted data. Surgical information and postoperative outcomes were analyzed. Only randomized controlled trial (RCT) articles were included, and subgroup analysis was established to deal with heterogeneity. RevMan 5.3 software was selected to conduct the meta-analysis. RESULT Eleven RCTs were included in our meta-analysis. There were significant differences in blood loss (P < .001), surgical field quality (P < .001), edema rating of upper (P < .001) and lower (P < .001) eyelid, ecchymosis rating of upper (P < .001) and lower eyelid (P < .001) when comparing the TXA group to the placebo group. However, the difference in operation time (P = .57) was not significant between the two groups. CONCLUSION Perioperative TXA could reduce the blood loss and improve the quality of surgery field during nasal surgery, and it was helpful for reducing the edema and ecchymosis after nasal surgeries, but it has little influence in reducing the operation time.
Antifibrinolytic therapy for preventing oral bleeding in people on anticoagulants undergoing minor oral surgery or dental extractions
The Cochrane Database of Systematic Reviews. 2018;((7)):CD012293.
BACKGROUND Individuals on continuous treatment with vitamin K antagonists (VKAs) or direct oral anticoagulants (DOACs) are at increased risk of bleeding complications during and after oral or dental procedures. Anticoagulant treatment is preferably continued at the same dose, since dose reduction or discontinuation of treatment is associated with an increased risk of thromboembolism. The use of haemostatic measures during or after the procedure (or both) could enable continuation of the oral anticoagulant treatment. OBJECTIVES We aimed to assess the efficacy of antifibrinolytic agents for preventing bleeding complications in people on oral anticoagulants undergoing minor oral surgery or dental extractions. SEARCH METHODS We searched the Cochrane Cystic Fibrosis and Genetic Disorders Coagulopathies Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books. We also searched the reference lists of relevant articles and reviews. We searched PubMed, Embase and the Cochrane Library. Additional searches were performed using ClinicalTrials.gov, the International Clinical Trials Registry Platform (ICTRP), the CINAHL database of nursing and allied health services, the open access ProQuest dissertation database, papers and reports from the American College of Clinical Pharmacy (ACCP) and abstract books from annual scientific conferences.Date of last search: 04 January 2018. SELECTION CRITERIA Randomised and quasi-randomised controlled trials in people on continuous treatment with VKAs or DOACs undergoing oral or dental procedures using antifibrinolytic agents (tranexamic acid (TXA) or epsilon aminocaproic acid) to prevent perioperative bleeding compared to no intervention or usual care with or without placebo. DATA COLLECTION AND ANALYSIS Two authors independently screened the titles and abstracts of all identified articles. Full texts were obtained from potentially relevant abstracts and two authors independently assessed these for inclusion based of the selection criteria. A third author verified trial eligibility. Two authors independently performed data extraction and risk of bias assessments using standardized forms. The quality of the evidence was assessed using GRADE. MAIN RESULTS No eligible trials in people on continuous treatment with DOACs undergoing oral or dental procedures were identified.Three randomised trials and one quasi-randomised trial (follow-up in all was seven days) in people on continuous treatment with VKAs were included with a total of 253 participants (mean age 60 years). Two trials published in 1989 and 1993 compared the antifibrinolytic agent TXA with placebo in people using VKAs. Two other trials were published in 1999 and 2015 and compared TXA with gelatin sponge and sutures, and dry gauze compression, respectively. In all included trials, those who were treated with VKAs had international normalised ratio (INR) values within the therapeutic range and TXA was applied locally, not systemically.The two trials from 1989 and 1993 comparing TXA with placebo showed a statistically significant beneficial effect regarding the number of major postoperative bleeding episodes requiring intervention, with a pooled risk difference (RD) of -0.25 (95% confidence interval (CI) -0.36 to -0.14) (128 participants) (moderate-quality evidence). For the two trials that compared TXA with either gelatin sponge and sutures or with dry gauze compression, there was no difference between the TXA and the standard care group, RD 0.02 (95% CI -0.07 to 0.11) (125 participants) (moderate-quality evidence). The combined RD of all included trials was -0.13 (95% CI -0.30 to 0.05) (moderate-quality evidence). There were no side effects of antifibrinolytic therapy that required treatment withdrawal (128 participants) (moderate-quality evidence). Despite heterogeneity between trials with respect to the different haemostatic measures used in the control groups, the trials were comparable regarding design and baseline participant characteristics.Overall, we co