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1.
Efficacy of Tranexamic Acid in Preventing Alveolar Osteitis in Post-extraction Sockets of First Premolars
Nagaja, S. A., John, R. S., Krishnan, M.
Cureus. 2024;16(1):e51816
Abstract
OBJECTIVES The present study is a randomized trial for comparing the effectiveness of tranexamic acid as an antifibrinolytic agent in preventing alveolar osteitis in the post-extraction period in patients receiving orthodontic therapy that requires extraction. METHODOLOGY This research was carried out in the Department of Oral and Maxillofacial Surgery, Saveetha Dental College and Hospitals, Chennai, India. A total of 40 patients were considered subjects for the research. Patients undergoing orthodontic treatment referred to the Department of Oral and Maxillofacial Surgery for the therapeutic extractions of the first premolars were considered for this study. Randomization was done to split the population into study and control. After the atraumatic extraction of the first premolars under local anesthesia using 2% lignocaine with 1:80000 adrenaline, a tranexamic acid solution of 500 mg soaked gauze over the extraction sockets was used as the intervention in the study group, and plain gauze was used on the control group. Patients were asked to hold the gauze in place for one hour. Participants were reviewed after three days for the incidence of alveolar osteitis and pain severity and healing of the extraction sockets. Results: The prevalence of Alveolitis sicca dolorosa was found to be 5% in the research group and 15% in the control group. Patients in the control group showed more pain than the patients in the research group. The period taken for healing ranged from 7 days to 10 days in the control group and 10 days to 12 days in the study group. Conclusion: This study gives an edge that tranexamic acid can be used as a local hemostatic agent in preventing fibrinolysis of clots and preventing alveolar osteitis.
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2.
The Efficacy of Tranexamic Acid in Craniomaxillofacial Surgery: A Systematic Review of Randomized Controlled Trials
Zhao, M., Luo, Y., Guo, Z., Mu, L., Lu, J.
The Journal of craniofacial surgery. 2023
Abstract
This study aimed to evaluate the use of tranexamic acid in craniomaxillofacial surgery by meta-analysis. A comprehensive search was performed for randomized controlled trials (RCTs) mainly in 3 electronic databases (PubMed, EMBASE, and Cochrane Library) before August 2022. We collected and managed data for weighted mean difference of intraoperative blood loss, transfusion requirement, and operation time for the study. A total of 13 randomized controlled trials were included in the analysis. Compared with the control group, the tranexamic acid group showed a reduction in intraoperative blood loss of 198.67 ml (95% CI: -258.84 to -138.50 ml, P<0.00001), with blood transfusion requirement decreased by 7.77 ml/kg (95% CI: -10.80 to -4.73, P<0.0001) and less operation time (weighted mean difference= -10.39 min; 95% CI: -16.49 to -4.30 min, P=0.0008).
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3.
Tranexamic Acid Irrigation in Liposuction: A Double-Blind, Half-Body, Randomized, Placebo-Controlled Trial
Wolf, Y., Skorochod, R., Kwartin, S., Shapira, L.
Aesthetic Plastic Surgery. 2023
Abstract
BACKGROUND Hematomas are common complications following plastic and esthetic surgeries. Large and complex hematomas might result in prolonged hospitalization, further interventions, additional expenses, and poor esthetic outcome. Tranexamic acid (TXA), an antifibrinolytic agent, has long been used to reduce blood loss. Its use in the field of plastic surgery has gained popularity recently. Several studies have presented the ability of TXA to reduce blood loss, hematomas, and ecchymoses after liposuctions. However, the proper dose and the route of administration remained controversial. OBJECTIVE The objective of the study was to quantify the effect of a low dose of TXA in an irrigation method in reducing hematomas and ecchymoses following liposuction. METHODS A prospective randomized controlled trial was conducted. Following liposuction, 400 mg of TXA were administered in an irrigation protocol to one side of the body in each patient, while the other side was administered with saline. The patients were photographed on 1, 2, 4, and 11 post-operative days. Ecchymosis and hematoma were measured and rated. RESULTS No statistical difference was observed between the intervention and control groups in terms of RBC in liposuction area (p = 0.11), RBC in lipoaspirate (p = 0.79), bruising size on days 1, 2, 4, and 11 (p = 0.68, 0.21, 0.42, and 0.75), and average ecchymosis score on the same days (p = 0.34, 0.72, 0.09, and 1) CONCLUSIONS The use of a low-dose TXA irrigation solution did not demonstrate a statistically significant difference in post-operative hematoma formations rates and subsequent ecchymosis size and scale. LEVEL OF EVIDENCE II This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .
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4.
Risk of bleeding in anticoagulated patients undergoing dental extraction treated with topical tranexamic acid compared to collagen-gelatin sponge: Randomized clinical trial
de Abreu de Vasconcellos, S. J., Souza Dos Santos Marques, R., Gomes Magalhães de Melo, E., Silva de Almeida, C., de Almeida Góes Silva, J. V., de Almeida Souza, L. M., Martins-Filho, P. R.
Journal of cranio-maxillo-facial surgery : official publication of the European Association for Cranio-Maxillo-Facial Surgery. 2023;51(6):393-398
Abstract
This two-arm, parallel-group, double-blind, randomized clinical trial design evaluated the risk of postoperative bleeding in anticoagulated patients undergoing dental extraction treated with topical TXA in comparison to collagen-gelatin sponge. Forty patients were randomly included in one of the study groups: (1) topical use of 4.8% TXA solution; and (2) resorbable hydrolyzed collagen-gelatin sponge applied to the surgical alveolus. Primary outcomes were postoperative bleeding episodes and secondary outcomes were thromboembolic events and postoperative INR values. The relative risk (RR), the absolute risk reduction (RAR) and the number needed to treat (NNT) were used as effect estimates and calculated from the counting of bleeding episodes observed during the first postoperative week. The bleeding rate under the TXA treatment was 22.2%, while in the collagen-gelatin sponge group it was 45.7%, resulting in a RR of 0.49 (95% CI 0.24-099; p = 0.046), RAR 23.5% and NNT 4.3. TXA was more effective in reducing bleeding in surgical sites located in the mandible (RR = 0.10; 95% CI 0.01-0.71; p = 0.021) and the posterior region (RR = 0.39; 95% CI 0.18-0.84; p = 0.016). Within the limitations of the study it seems that topical TXA is more effective in controlling bleeding after tooth extractions in anticoagulated patients than collagen-gelatin sponge. CLINICAL TRIAL REGISTRATION RBR-83qw93.
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5.
The Effect of Tranexamic Acid Local Injection on Bleeding during and after Tonsillectomy: A Double-Blind Randomized Placebo-Controlled Trial
Abtahi, M., Kargoshai, A. A., Shetabi, H., Manafi, A., Manafi, N., Badrouj, A.
World journal of plastic surgery. 2023;12(3):31-36
Abstract
BACKGROUND Tonsillectomy-related bleeding is one of the most prevalent and potentially fatal complications of this common surgical procedure. We aimed to assess the effect of tranexamic acid (TXA) local injection on bleeding during and after tonsillectomy. METHODS This double-blind, randomized placebo-controlled trial included 20 candidates for tonsillectomy referred to Al-Zahra Hospital, Isfahan University of Medical Sciences, Isfahan, Iran, in 2022. The subjects were randomized into two groups. Ten patients received TXA on their left side and the other ten on their right side 10 min before surgery. Placebo was administered to the contralateral side. The primary outcome was the volume of blood loss during tonsillectomy and up to 24 hours post-tonsillectomy. The secondary outcomes were surgeon satisfaction (rated 0-10), hemodynamic complications (patients' heart rate (HR) and mean arterial pressure (MAP) were recorded every 10 min), and rebleeding. The duration of surgery was also noted. RESULTS The mean age of the patients was 21.35 ± 3.16 years, of whom 8 (30%) were male and 12 (60%) were female. there was no significant difference between groups in terms of HR and MAP at any time point. The median of surgery duration did not differ significantly between the two groups; however, the surgeon satisfaction with the procedure was significantly higher with TXA compared to placebo. None of the patients developed hemodynamic complications, and rebleeding did not occur in any of the subjects. CONCLUSIONS TXA local injection was not superior to placebo in terms of bleeding control during and after tonsillectomy, hemodynamic complications, rebleeding, and surgery duration.
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6.
Evaluating the Effect of Tranexamic Acid Local Injection on the Intraoperative Bleeding Amount and the Postoperative Edema and Ecchymosis in Primary Rhinoplasty Patients: A Randomized Clinical Trial
Vaghardoost, R., Ahmadi Dahaj, A., Haji Mohammad, M., Ghadimi, T., Forghani, S. F., Naderi Gharahgheshlagh, S.
Aesthetic plastic surgery. 2023
Abstract
BACKGROUND AND AIMS The purpose of this study was assessing the effect of local injection of tranexamic acid (TXA) on the amount of bleeding during the primary rhinoplasty and edema and ecchymosis following the surgery. METHODS In this randomized clinical trial, 50 patients applying for primary rhinoplasty were divided into two groups of intervention and observation. In the intervention group, 10 mg/kg of TXA was injected locally to the operation field. In the observation group, no medicine was injected. The same anesthesia technique was used during the operation for all the patients. Age, sex, blood pressure, bleeding amount during the operation, the amount of edema and ecchymosis on the first and seventh day after the surgery were noted. The data were analyzed by the SPSS software version 24 and using descriptive statistics of frequency and percentage of frequency and Fisher and Mann-Whitney's exact statistical tests. RESULTS Our results showed that there was a significant difference between the amounts of bleeding during the surgery between two groups (P-value < 0.001). Also, the postoperative edema on the first and seventh day in intervention group was less than the observation group (P-value < 0.001). There were no complications during the surgery and in the follow-up of the patients. CONCLUSION We revealed that local injection of TXA during the rhinoplasty procedure and decreased the intraoperative bleeding and postoperative ecchymosis and edema without any side effects and complications. LEVEL OF EVIDENCE III This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.
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7.
Efficacy of tranexamic acid in prevention of alveolar osteitis following surgical removal of impacted mandibular third molar
Jadhav AN, Shushma G, Deshmukh VD
National journal of maxillofacial surgery. 2022;13(Suppl 1):S85-s90
Abstract
CONTEXT Many preventive measures are described to avoid alveolar osteitis (AO) during third molar surgery (TMS), but very few are found to be effective. Tranexamic acid (TA), an antifibrinolytic agent, impedes the proteolytic degradation of fibrin and prevents blood clot disintegration. AIMS The study was conducted to determine the efficacy of intra-alveolar application of TA soaked in Gelfoam in prevention of AO. SETTINGS AND DESIGN This was a randomized control trial. MATERIALS AND METHODS A total of 200 patients (100 in control group and 100 in study group) reporting for TMS were allocated randomly. Following surgery, TA soaked in gel foam was placed in socket and sutured in the study group, while in the control group, closure was done by suturing. Patients followed subsequently to observe the incidence of AO, pain severity, and duration of healing after AO. STATISTICAL ANALYSIS Z-test, Mann-Whitney test, and t-test were applied, respectively, to compare the incidence of AO, severity of pain, and duration of healing between the two groups. RESULTS The incidence of AO in the control group was 18% and 6% in the study group. Patients in the control group experienced severe pain as compared to patients in the study group. The duration of healing varied from 12 to 16 days in the control group, but in the study group, it was <10 days. CONCLUSION TA significantly reduces the incidence of AO in addition to the reduced severity of pain and enhanced healing. We recommend the routine use of TA, owing to its astonishing rewards.
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8.
The effect of tranexamic acid on blood loss in orthognathic surgery: a randomized, placebo-controlled, equivalence study
Jozefowicz E, Sabourdin N, Lambelin V, Lejeune V, Delassus R, Tavernier B
International journal of oral and maxillofacial surgery. 2021
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.
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9.
Is Preoperative Administration of Tranexamic Acid Effective on Blood Loss Reduction in Mandibular Fracture Surgeries? A Triple-Blind Randomized Clinical Trial
Khiabani, K., Ahmadfar, M., Labafchi, A., Gosheh, M. R., Samieirad, S.
Journal of Oral and Maxillofacial Surgery : Official Journal of the American Association of Oral and Maxillofacial Surgeons. 2021;79(2):429.e1-429.e7
Abstract
PURPOSE Hemorrhage is one of the significant factors that cause adverse reactions and complications during trauma management. This study aimed to investigate the effectiveness of preoperative tranexamic acid (TXA) administration on intraoperative blood loss in mandibular fracture surgeries. MATERIALS AND METHODS The authors implemented a triple blinded randomized clinical trial. All healthy young patients who suffered from bilateral displaced mandibular angle and body fractures were included in this study. All operations were performed using open reduction and internal fixation by the same surgical team. The eligible subjects were randomly divided into 2 equal groups. The anesthesiology staff administered the intravenous TXA (20 mg/kg) to the intervention group and 20 mL of intravenous normal saline (0.09%) in the control group, 30 minutes preoperatively. The study outcome variables included intraoperative blood loss and hemoglobin loss. The data were statistically analyzed in SPSS, version 20 (SPSS Inc, Chicago, IL). RESULTS Fifty patients, including 31 males (62%) and 19 females (38%), with the mean age of 28 ± 5.6 years were studied. The mean blood loss was 360.57 ± 173.5 mL and 560.9 ± 248.07 mL in the TXA and control groups, respectively. This difference was statistically significant (P = .008). In addition, the mean drop in hemoglobin value was 0.91 ± 0.33 mg/dL in the intervention group and 1.44 ± 0.45 mg/dL in the control group, with a significant difference (P = .001). No adverse effect was observed in the TXA cases. CONCLUSIONS TXA is a safe and effective drug for reducing intraoperative blood loss in patients who underwent mandibular fracture open reduction and internal fixation surgeries.
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10.
Tranexamic acid and bleeding in patients treated with non-vitamin K oral anticoagulants undergoing dental extraction: The EXTRACT-NOAC randomized clinical trial
Ockerman A, Miclotte I, Vanhaverbeke M, Vanassche T, Belmans A, Vanhove J, Meyns J, Nadjmi N, Van Hemelen G, Winderickx P, et al
PLoS medicine. 2021;18(5):e1003601
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.