Efficacy, safety, tolerability and treatment durability of microneedling plus topical tranexamic acid in combination with topical modified Kligman lightening formula for melasma: A four-arm assessor and analyst blinded randomized controlled clinical trial.

BACKGROUND: The challenging management of melasma highlights the inadequacies of conventional therapies and their high risk of recurrence. Integrating microneedling for device-assisted drug delivery with tranexamic acid (TA), recognized for its melanin synthesis inhibition, presents a novel approach that warrants further investigation to fully assess its potential in enhancing melasma treatment efficacy. METHODS: Fifty moderate to severe melasma patients participated in this randomized outcome-assessor-blinded controlled trial. Patients were randomly allocated into two main groups. Group A received a modified Kligman formula on one hemi-face on alternate nights for 2 months (A1) and three sessions of microneedling with 10% topical TA on the other hemi-face at 1-month intervals (A2). Group B used the same modified Kligman formula on both sides of the face, with one side additionally receiving three sessions of microneedling with 4% TA (B1) and the opposite side with 10% TA (B2). Primary outcomes were % Modified Melasma Area and Severity Index (mMASI) and % visual analogue scale (VAS) change during 6 month follow-up. Adverse events including post-inflammatory hyperpigmentation (PIH) and treatment tolerability were recorded. RESULTS: Compared to baseline, the mean mMASI reduction immediately after the final session was higher in A1, B1, and B2 (56.84%, 50.88%, and 55.87%, respectively) than in A2, which saw only a 13.16% reduction. Efficacy notably declined after the cessation of treatment across all groups. While the efficacy within groups A1, B1, and B2 was comparable, microneedling with 4% or 10% TA combined with the topical modified Kligman formula proved more potent in patients at a lower risk of PIH. Overall, 22% of patients reported PIH, particularly in the A2 group (28% of hemi-faces), with its occurrence significantly associated with treatment during warmer seasons and in darker skin phototypes. Other adverse events were not observed in any patient. Patient satisfaction was highest in groups B1 and B2, where approximately 72% reported 'excellent' satisfaction. The lowest durability rate (16%) was observed in group A2, while the highest (72%) was seen in group B2, comparable with groups A1 and B1. Treatment tolerability was reported 100% in all groups. CONCLUSION: It was found that the modified Kligman formula outperformed microneedling-TA alone. However, with optimal patient selection, particularly targeting those at lower risk for PIH with lighter skin phototypes and scheduling treatments during less-sunny seasons, combining microneedling with 4% or 10% TA and the modified Kligman formula significantly enhanced efficacy and satisfaction rates compared to conventional topical treatment.

Use of Intravenous Tranexamic Acid in Patients Undergoing Plastic Surgery: Implications and Recommendations per a Systematic Review and Meta-Analysis.

With increasing interest in aesthetic plastic procedures, the event of blood loss has compromised patients' safety and satisfaction. Tranexamic acid (TXA) is a drug used for the reduction of blood loss during surgical procedures. This systematic review aims to evaluate the clinical efficacy and safety of TXA in aesthetic plastic surgery for the reduction of bleeding and related complications. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed. Electronic databases PubMed, EMBASE, Cochrane Library, and Google Scholar were searched. The medical subject headings (MeSH) keywords used for data extraction were ("TXA," OR "tranexamic acid,") AND ("plastic surgery," OR "aesthetic surgery," OR "rhinoplasty," OR "blepharoplasty,") AND ("blood loss" OR "bleeding" OR "TBL") AND ("Edema" OR "ecchymosis"). A combination of these MeSH terms was used in the literature search. The timeline of research was set from 2015 to January 2024. A total of 7380 research articles were identified from the above-mentioned databases, and only 13 research articles met the inclusion criteria. There was a significant difference in total blood loss (TBL) among patients who had undergone plastic surgery procedures while on TXA as compared to a placebo (mean difference = -6.02; Cl: -1.07 to -0.16; p > 0.00001), and heterogeneity was found (degrees of freedom (df) = 9; I2 = 97%). Only two studies reported the average ecchymosis scores after TXA among interventions in comparison to the placebo group. This review provides evidence that TXA lowers TBL, ecchymosis, edema, and anemia during cosmetic surgery without significantly increasing thromboembolic consequences.

Incidence of Subclinical Deep Vein Thrombosis after Total Hip and Knee Arthroplasty Is Not Correlated with Number of Tranexamic Acid Doses.

Background: Recent studies increasingly highlight the efficacy of tranexamic acid administration in total hip arthroplasty (THA) and total knee arthroplasty (TKA). However, the optimal dosage of tranexamic acid is still controversial. Methods: The current study analyzes the efficiency of tranexamic acid dosage and the number of administrations in THA and TKA. The objective of this study is to compare the incidence of deep vein thrombosis (DVT) based on the number of dosages. We divided the patients into two groups; one group received a single dosage, and the other group received two dosages. Doppler ultrasound examinations were conducted on the lower limbs of all patients at both six and thirty days postoperatively. The second objective is to compare the decrease in hemoglobin (Hb) in the two groups. Results: The results show that there is no difference in DVT incidence between the patients with different TXA numbers of dosages. There is no statistically significant decrease in Hb between the two groups at day one and day five postoperatively. Day one shows a statistically higher average in the two-dose group, approximately 0.06 g/dL, and day five shows a slightly elevated average in the single-dose group, approximately 0.06 g/dL. Blood transfusion requirements show no significant differences in the groups; one patient in the single-dose tranexamic acid group needed transfusion at day five postoperatively, while two patients in each group required immediate postoperative transfusion. Conclusion: There was no increase in the incidence of deep vein thrombosis among patients receiving two dosages of tranexamic acid.

Unravelling the Antifibrinolytic Mechanism of Action of the 1,2,3-Triazole Derivatives.

A new family of antifibrinolytic drugs has been recently discovered, combining a triazole moiety, an oxadiazolone, and a terminal amine. Two of the molecules of this family have shown activity that is greater than or similar to that of tranexamic acid (TXA), the current antifibrinolytic gold standard, which has been associated with several side effects and whose use is limited in patients with renal impairment. The aim of this work was to thoroughly examine the mechanism of action of the two ideal candidates of the 1,2,3-triazole family and compare them with TXA, to identify an antifibrinolytic alternative active at lower dosages. Specifically, the antifibrinolytic activity of the two compounds (1 and 5) and TXA was assessed in fibrinolytic isolated systems and in whole blood. Results revealed that despite having an activity pathway comparable to that of TXA, both compounds showed greater activity in blood. These differences could be attributed to a more stable ligand-target binding to the pocket of plasminogen for compounds 1 and 5, as suggested by molecular dynamic simulations. This work presents further evidence of the antifibrinolytic activity of the two best candidates of the 1,2,3-triazole family and paves the way for incorporating these molecules as new antifibrinolytic therapies.

Role of prophylactic tranexamic acid in reducing blood loss during cesarean section: A double-blind placebo-controlled randomized controlled trial.

Background: Postpartum hemorrhage (PPH) is defined by the World Health Organization as blood loss of ≥500 mL within 24 h of delivery. Globally, hemorrhage accounts for 27.1% of maternal deaths, making it the leading direct cause of maternal death. PPH has been identified in more than two-thirds of reported hemorrhage-related deaths, causing 38% of maternal deaths in India. Tranexamic acid, an antifibrinolytic, has been used to control bleeding after PPH is identified. Materials and Methods: Antenatal women admitted for elective cesarean section were randomized into two arms: the case group (received one gram of tranexamic acid 20 min prior to skin incision) and the control group (received a placebo), each group consisting of 36 participants. Clinical Trials Registry - India (CTRI) registration number - CTRI/2021/02/031579. Results: The mean (±standard deviation [SD]) intraoperative blood loss in the case group was 241.25 (±67.83) mL, and in the control group, it was 344.92 (±146.67) mL (P = 0.001), while postoperative blood loss did not differ significantly between the groups (P = 0.1470). In terms of the difference in hemoglobin, there was a significant difference between the two groups (P = 0.001). No significant maternal or neonatal side effects were found. Conclusion: Preoperative tranexamic acid, when given in elective cesarean section, significantly reduces intraoperative blood loss.

Efficacy of intraoperative use of tranexamic acid in reducing blood loss from telescoping nail application in osteogenesis imperfecta. A randomized controlled trial.

BACKGROUND: Osteogenesis imperfecta (O.I) is a rare disease caused by an abnormality in type 1 collagen synthesis leading to repeated fractures after low-energy trauma and progressive long bones deformity. Telescoping nail application and surgical correction of these deformities usually necessitates multiple osteotomies and significant bleeding occur due to weakened capillaries and impaired platelet activity. Tranexamic acid (TXA) has an antifibrinolytic effect which is useful in reducing bleeding and need for blood transfusions following several orthopaedic procedures. HYPOTHESIS: The use of intraoperative (Local and Intravenous) tranexamic acid reduces blood loss during femoral telescoping nail application in O.I. MATERIAL AND METHODS: A prospective randomized controlled study was carried out on 40 patients during applying femoral telescoping nail divided into Group A: (case TXA); 20 patients receiving intraoperative TXA and Group B: (control); 20 patients not receiving TXA. Blood loss and perioperative Hemoglobin (Hb) and Hematocrit Level (Hct) were assessed. RESULTS: The study included 29 males and 11 females with mean age 7.98 years. The number of osteotomies in both groups ranged from zero to 3 osteotomies with a median one osteotomy. A significant decrease in blood loss was observed in TXA group (mean 241.5 cc) compared to control group (mean 461.5 cc). Postoperative Hb was significantly lower in control group (mean 12.30 g/dL changed to 10.45 g/dL) compared to TXA group (mean 12.26 g/dL changed to 11.52 g/dL). Also, postoperative Hct was significantly lower in control group (m:ean 37.37 % changed to 32.03%) compared to TXA group (mean 36.53 % changed to 34.66 %). DISCUSSION: The use of TXA during femoral telescoping nail application in OI patients has contributed to a remarkable reduction in overall blood loss. Consideration of adding it to management protocol is advised. LEVEL OF EVIDENCE: II; Randomized Controlled Trial (RCT).

The Association Between Tranexamic Acid and Seizures in Moderate or Severe Traumatic Brain Injury.

INTRODUCTION: Tranexamic acid (TXA) administered within 2 h of injury reduces mortality in traumatic brain injury (TBI) with intracranial hemorrhage. TXA also reduces the seizure threshold in a dose-dependent manner. We examined whether a 2-g bolus of prehospital TXA administered in moderate or severe TBI is associated with seizure activity within 72 h of injury. METHODS: Patients from the prehospital TXA for TBI trial with Glasgow Coma Scale < 13, blunt head injury, and time-of-seizure data were included in this analysis. The original trial randomized patients with suspected TBI to placebo, 1-g TXA bolus + 1-g 8-h TXA infusion, or 2-g TXA bolus within 2 h of injury. In this secondary analysis, multivariable logistic regression was performed to examine the association of treatment group with seizure incidence. The model controlled for age, Glasgow Coma Scale, Injury Severity Score, intracranial hemorrhage, Abbreviated Injury Scale-head, and home antiseizure medication use. RESULTS: Of the 786 patients who met the inclusion criteria, 19 had seizures within 72 h (five in placebo, two in 1-g bolus/1-g infusion, and 12 in 2-g bolus). The 2-g TXA bolus was not associated with increased seizures compared to placebo (odds ratio 0.41, 95% confidence interval 0.12-1.18, P = 0.12). Home antiseizure medication use was associated with increased seizures (odds ratio 15.95, 95% confidence interval 3.79-60.57, P < 0.001). CONCLUSIONS: A prehospital 2-g TXA bolus in moderate or severe TBI was not associated with increased seizure activity during the first 72 h after injury; however, limited power, limited use of continuous electroencephalography, and unavailable seizure prophylaxis data highlight the need for further study.

The emerging role of tranexamic acid and its principal target, plasminogen, in skeletal health.

The worldwide burden of skeletal diseases such as osteoporosis, degenerative joint disease and impaired fracture healing is steadily increasing. Tranexamic acid (TXA), a plasminogen inhibitor and anti-fibrinolytic agent, is used to reduce bleeding with high effectiveness and safety in major surgical procedures. With its widespread clinical application, the effects of TXA beyond anti-fibrinolysis have been noticed and prompted renewed interest in its use. Some clinical trials have characterized the effects of TXA on reducing postoperative infection rates and regulating immune responses in patients undergoing surgery. Also, several animal studies suggest potential therapeutic effects of TXA on skeletal diseases such as osteoporosis and fracture healing. Although a direct effect of TXA on the differentiation and function of bone cells in vitro was shown, few mechanisms of action have been reported. Here, we summarize recent findings of the effects of TXA on skeletal diseases and discuss the underlying plasminogen-dependent and -independent mechanisms related to bone metabolism and the immune response. We furthermore discuss potential novel indications for TXA application as a treatment strategy for skeletal diseases.

Role of Tranexamic Acid in Controlling Blood Loss in Hemiarthroplasty of the Hip: A Prospective and Observational Study.

INTRODUCTION: Tranexamic acid, an antifibrinolytic drug, is well-established for its efficacy in reducing intraoperative and postoperative blood loss in major orthopedic surgeries, particularly total knee replacement (TKR) and spine surgeries. However, there is limited research on the role of tranexamic acid in hemiarthroplasty of the hip. This study aims to investigate the efficacy of tranexamic acid in controlling blood loss in hemiarthroplasty of the hip. OBJECTIVES: The primary objective was to analyze the pre- and postoperative changes in hemoglobin levels among patients undergoing hemiarthroplasty of the hip with and without intravenous tranexamic acid administration. METHODS: A prospective observational study was conducted at the Department of Orthopedics of Government Medical College, Kannur, and St. Joseph's Hospital, Karuvanchal, Kannur. Patients undergoing hemiarthroplasty of the hip with 1 gm of intravenous tranexamic acid were compared with those without tranexamic acid. The sample size was calculated to be 33 in each group. Data were collected using a standardized proforma, entered into an Excel sheet (Redmond, USA), and analyzed using IBM Corp. Released 2017. IBM SPSS Statistics for Windows, Version 25.0. Armonk, NY: IBM Corp. RESULTS: The study comprised mainly elderly females with a mean age of 74.84 ± 8 years. There was a significant reduction in postoperative hemoglobin drop, requirement for postoperative blood transfusion, and total drain output for the initial three postoperative days among patients who received intravenous tranexamic acid. CONCLUSION: Preoperative administration of intravenous tranexamic acid significantly reduced postoperative hemoglobin drop and the need for postoperative blood transfusion in patients undergoing hemiarthroplasty of the hip. This highlights the efficacy and safety of tranexamic acid in controlling blood loss in this surgical setting.

Tranexamic acid efficacy in geriatric hip fractures: impact of nutritional status on blood loss, transfusion rates, and safety.

BACKGROUND: Tranexamic acid (TXA) is a widely employed intervention in orthopedic surgeries to minimize blood loss and the need for postoperative transfusions. This study focuses on assessing the efficacy and safety of TXA specifically in undernourished older adults undergoing hip fracture procedures. METHODS: A total of 216 patients were classified into two groups based on the Geriatric Nutritional Risk Index: undernourished and normal. In total, 82 patients received intravenous TXA at a dosage of 15 mg/kg before incision, with an additional 1 g administered intravenously over a 3-hour period postoperatively. Postoperative hemoglobin (Hb) drop, blood transfusion rate, and the incidence of deep venous thrombosis (DVT) were assessed in each group according to the presence or absence of TXA. Additionally, demographic factors including age, sex, body mass index, and serum albumin were investigated. RESULTS: 51.9% patients were identified as undernourished, experiencing progressive anemia (Hb: 10.9 ± 1.5 g/dL) and hypoalbuminemia (serum albumin: 31.9 ± 8 g/L). In comparison with the normal group, undernourished individuals were more likely to sustain femoral neck fractures (undernutrition vs. normal: 56.2 vs. 42.3%) and less likely to incur trochanteric fractures (undernutrition vs. normal: 43.8 vs. 57.7%) (P = 0.043). TXA administration significantly reduced the transfusion rate (P = 0.014) and Hb drop (P = 0.001) in the normal nutritional group, while its impact on the undernourished group remained less pronounced. There was no significant association between TXA administration and the rate of DVT complications, irrespective of the nutritional status. CONCLUSIONS: Undernutrition not only diminishes muscle strength and gait function, leading to various types of hip fractures, but it may also hinder the efficacy of TXA in reducing blood transfusion rates and blood loss.

Venous Thromboembolic Events in Adult Trauma Patients Receiving Balanced Hemostatic Resuscitation (BHR): An Analysis of Their Incidence, Predictors, and Associated Mortality Rates at a Level 1 Trauma Center.

Background and objective Studies assessing the incidence of venous thromboembolic (VTE) events in the setting of massive balanced transfusions and/or tranexamic acid (TXA) infusion have yielded varied outcomes. In light of this, we conducted this study to examine the incidence of VTEs in trauma patients requiring blood products, and to identify the risk factors for VTE and mortality in this population. Methods We performed a retrospective analysis of trauma patients admitted to our level 1 trauma center from January 2013 to September 2023. Clinical characteristics were compared between patients who developed VTE and those who did not. A regression analysis of potential variables associated with the development of VTEs and mortality was performed. Results Among 1305 patients (mean age: 42.4 ± 18.8 years) receiving blood products within the initial 24 hours, 4.3% (56 patients) developed a VTE. Patients with VTE experienced prolonged ICU and hospital stays and ventilation duration (p<0.001). They were also noted to have delayed initiation of VTE prophylaxis (104.2 vs. 50.3 hours, p<.001). Prolonged ventilation >7 days was the sole significant factor associated with VTE in multivariate regression analysis [odds ratio (OR): 6.2, p=0.004]. Early TXA administration (within four hours) showed a higher association with VTE than TXA within 24 hours (OR: 2.1, p=0.07 vs. OR 1.6, p=0.22). Massive transfusion was found to increase VTE risk (OR: 2.65, p<0.001). Severe head and neck (OR: 6.0, p=0.002) and chest (OR: 3.8, p=0.01) injuries were key predictors of mortality, while TXA was not significantly associated with mortality in the multivariate model. Conclusions Our study revealed an elevated risk of VTE in patients requiring massive transfusion protocol (MTP, ≥6 units). Early TXA administration was neither associated with increased VTE risk in MTP patients nor increased mortality risk. Strategies directed at reducing the risk of VTE in massively transfused patients while maintaining the survival benefits of balanced resuscitation and TXA need to be devised.

Computational Discovery of AngiomiRs and Evaluating the Synergistic Effects of Target miRNA with Tranexamic Acid in Colorectal Cancer.

INTRODUCTION: microRNA (miRNA) levels are dysregulated in many cancers, suggesting that miRNA-based therapy may be effective. The molecular pathways of colorectal cancer (CRC) development are unknown. METHOD: Understanding miRNAs implicated in CRC formation may reveal new diagnostic and therapeutic targets. Angiogenesis is a key mechanism in tumor growth. CRC treatment may involve inhibiting angiogenesis, but existing drugs can cause negative effects. Tranexamic acid, an FDA-approved medication, may reduce the adverse effects of angiogenesis inhibitors. This work examined miRNAs implicated in CRC angiogenesis and how miR-16 and tranexamic acid may synergistically decrease CRC cell migration and angiogenesis. We identified miRNAs targeting CRC angiogenesis genes using bioinformatic databases. Proteins were docked with tranexamic acid utilizing the PyRx software. Quantitative Real-time PCR was used to analyze the effects of overexpressed miRNA and tranexamic acid on the expression of target genes. Scratch, transwell migration, and Chicken Chorioallantoic Membrane (CAM) assays were used to evaluate the effect of selected miRNA and tranexamic acid on the invasion and angiogenesis of CRC cells. in silico studies identified hsa-miR-16-5p, -101-3p, and 34a-5p as possible CRC angiogenesis modulators. RESULTS: The study found that miR-16 and tranexamic acid influence the expression of VEGFA, ANGPT2, MMP9, and HIF1A. miR-16 and tranexamic acid influenced CRC cell movement in scratch tests and transwell migration assays. Furthermore, the CAM assay results demonstrated that miR-16 and tranexamic acid can alter angiogenesis in CRC. CONCLUSION: These findings highlight the potential of miR-16 and tranexamic acid as combination therapeutic agents for CRC, with the ability to simultaneously target tumorigenesis and angiogenesis.

Tranexamic acid versus oxytocin prophylaxis in reducing post-partum blood loss, in low-risk pregnant women: TRANOXY STUDY, a phase III randomized clinical trial.

Background: To assess the equivalence of tranexamic acid (TRAN) versus synthetic oxytocin (OXY) in reducing post-partum blood loss, in full-term patients (37-42 weeks), at low risk of post-partum hemorrhage, with vaginal childbirth. Methods: Phase III, randomized (1:1), open-label, longitudinal, multi-center, prospective clinical trial (Prot. n 63209, ClinicalTrials.gov Identifier: NCT02775773). From January 7, 2020, to June 30, 2023, a total of 256 women were enrolled at two general urban community hospitals in Italy, serving a multi-ethnic patient population with National Health Insurance. The primary outcome was to explore a potential equivalence between the two treatments (OXY and TRAN) in preventing total blood loss. Therefore, we randomized 231 women into two groups: Group A (OXY), 127 women who were administered 10UI intramuscularly within 5 min from childbirth; Group B (TRAN), 104 women to whom 1-g slow intravenous infusion was administered within 5 min from childbirth. Findings: At the time of delivery, mean blood loss for OXY group versus TRAN group was 269.12 mL versus 263.88 mL, respectively, with equivalence between the two groups. Similarly, there was equivalence in total blood loss between the OXY and the TRAN group (397.66 mL versus 405.64 mL, respectively. No statistical differences between Hb levels at admission and discharge in the two groups were reported. No difference was found in terms of additional uterotonic and surgical therapies between the two groups of patients. Neither group showed thrombotic complications at check-up performed after 7 days or after a questionnaire regarding adverse effects, subjected after 40 days. Interpretation: The study shows the equivalence of tranexamic acid versus synthetic oxytocin in post-partum blood loss prophylaxis in term patients at low risk of PPH with vaginal childbirth. The safety profiles of OXY and TRAN were similar. Funding: None.

Hemostatic effects of tranexamic acid in cardiac surgical patients with antiplatelet therapy: a systematic review and meta-analysis.

BACKGROUND: The purpose of the current study was to assess the efficacy of tranexamic acid (TXA) on reducing bleeding in cardiac surgical patients with preoperative antiplatelet therapy (APT). METHODS: Five electronic databases were searched systematically for randomized-controlled trials (RCTs) assessing the impact of intravenous TXA on post-operative bleeding on cardiac surgical patients with preoperative APT until May 2024. Primary outcome of interest was post-operative blood loss. Secondary outcomes of interest included the incidence of reoperation due to post-operative bleeding, post-operative transfusion requirements of red blood cells (RBC), fresh-frozen plasma (FFP), and platelet concentrates. Mean difference (MD) with 95% confidence interval (CI) or odds ratios (OR) with 95% CI was employed to analyze the data. Subgroup and meta-regression analyses were performed to assess the possible influence of TXA administration on reducing bleeding and transfusion requirements. RESULTS: A total of 12 RCTs with 3018 adult cardiac surgical patients (TXA group, 1510 patients; Control group, 1508 patients) were included. The current study demonstrated that TXA significantly reduced post-operative blood loss (MD = - 0.38 L, 95% CI: - 0.73 to - 0.03, P = 0.03; MD = - 0.26 L, 95% CI: - 0.28 to - 0.24, P < 0.00001; MD = - 0.37 L, 95% CI: - 0.63 to - 0.10, P = 0.007) in patients receiving dual antiplatelet therapy (DAPT), aspirin, or clopidogrel, respectively. Patients in TXA group had significantly lower incidence of reoperation for bleeding as compared to those in Control group. The post-operative transfusion of RBC and FFP requirements was significantly lower in TXA group than Control group. Subgroup analyses showed that studies with DAPT discontinued on the day of surgery significantly increased the risk of post-operative blood loss [(MD: - 1.23 L; 95% CI: - 1.42 to - 1.04) vs. (MD: - 0.16 L; 95% CI: - 0.27 to - 0.05); P < 0.00001 for subgroup difference] and RBC transfusion [(MD: - 3.90 units; 95% CI: - 4.75 to - 3.05) vs. (MD: - 1.03 units; 95% CI: - 1.96 to - 0.10); P < 0.00001 for subgroup difference] than those with DAPT discontinued less than 5-7 days preoperatively. CONCLUSIONS: This meta-analysis demonstrated that TXA significantly reduced post-operative blood loss and transfusion requirements for cardiac surgical patients with preoperative APT. These potential clinical benefits may be greater in patients with aspirin and clopidogrel continued closer to the day of surgery. TRIAL REGISTRATION NUMBER: CRD42022309427.

Topical Tranexamic Acid to Control Vaginal Laceration Bleeding after Sexual Assault.

BACKGROUND: Sexual assault survivors may sustain vaginal trauma that requires intervention in the emergency department, or operating room. CASE REPORT: We describe the case of a 16-year-old female who was referred to the emergency department for evaluation of continued bleeding from a vaginal laceration following sexual assault 38 h prior. The bleeding limited the medical forensic medical examination, but she was hemodynamically stable. After the application of tranexamic acid (TXA)-soaked gauze, the patient's bleeding was controlled and the wound was able to be evaluated and the examination completed. WHY SHOULD AN EMERGENCY PHYSICIAN BE AWARE OF THIS?: To our knowledge, this is the first case in the literature that describes the use of topical TXA in a patient to achieve hemostasis in a vaginal laceration sustained from sexual violence.

Tranexamic acid may benefit patients with preexisting thromboembolic risk undergoing total joint arthroplasty: a systematic review and meta-analysis.

Purpose: This study sought to determine if the use of tranexamic acid (TXA) in preexisting thromboembolic risk patients undergoing total joint arthroplasty (TJA) was linked to an increased risk of death or postoperative complications. Methods: We conducted a comprehensive search for studies up to May 2023 in PubMed, Web of Science, EMBASE, and the Cochrane Library. We included randomized clinical trials, cohort studies, and case-control studies examining the use of TXA during TJA surgeries on high-risk patients. The Cochrane Risk of Bias instrument was used to gauge the excellence of RCTs, while the MINORS index was implemented to evaluate cohort studies. We used mean difference (MD) and relative risk (RR) as effect size indices for continuous and binary data, respectively, along with 95% CIs. Results: Our comprehensive study, incorporating data from 11 diverse studies involving 812 993 patients, conducted a meta-analysis demonstrating significant positive outcomes associated with TXA administration. The findings revealed substantial reductions in critical parameters, including overall blood loss (MD = -237.33; 95% CI (-425.44, -49.23)), transfusion rates (RR = 0.45; 95% CI (0.34, 0.60)), and 90-day unplanned readmission rates (RR = 0.86; 95% CI (0.76, 0.97)). Moreover, TXA administration exhibited a protective effect against adverse events, showing decreased risks of pulmonary embolism (RR = 0.73; 95% CI (0.61, 0.87)), myocardial infarction (RR = 0.47; 95% CI (0.40-0.56)), and stroke (RR = 0.73; 95% CI (0.59-0.90)). Importantly, no increased risk was observed for mortality (RR = 0.53; 95% CI (0.24, 1.13)), deep vein thrombosis (RR = 0.69; 95% CI (0.44, 1.09)), or any of the evaluated complications associated with TXA use. Conclusion: The results of this study indicate that the use of TXA in TJA patients with preexisting thromboembolic risk does not exacerbate complications, including reducing mortality, deep vein thrombosis, and pulmonary embolism. Existing evidence strongly supports the potential benefits of TXA in TJA patients with thromboembolic risk, including lowering blood loss, transfusion, and readmission rates.

Effect of Tranexamic Acid on Hidden Blood Loss in Percutaneous Endoscopic Transforaminal Lumbar Interbody Fusion: A Retrospective Study.

Purpose: Percutaneous endoscopic transforaminal lumbar interbody fusion (PE-TLIF) has become one of the most popular minimally invasive surgeries today. However, the issue of hidden blood loss (HBL) in this surgery has received little attention. This study aims to examine the HBL in PE-TLIF surgery and the effect of tranexamic acid (TXA) on blood loss. Methods: In our research, We conducted a retrospective analysis of 300 patients who underwent PE-TLIF from September 2019 to August 2023. They were divided into 2 groups based on whether they received intravenous TXA injection before surgery. The variables compared included: demographic data, pre-and postoperative hemoglobin (HB), hematocrit (HCT), platelets (PLT), red blood cells (RBC), total blood loss (TBL), visible blood loss (VBL), HBL, operation time, postoperative hospital stay, inflammatory markers, coagulation parameters, and adverse events. Results: Regarding demographic characteristics, besides the operation time, no significant differences were observed between the two groups. Compared with the control group, the TXA group showed a significant reduction trend in TBL, HBL, and VBL (P < 0.05). On the first day after surgery, there were significant differences in prothrombin (PT), activated partial thromboplastin time (APTT), and D-dimer (D-D) levels between the two groups. Similarly, HCT also found similar results on the third day after surgery. No adverse events occurred in either group. Conclusion: Research has found that there is a significant amount of HBL in patients undergoing PE-TLIF. Intravenous injection of TXA can safely and effectively reduce perioperative HBL and VBL. Additionally, compared to the control group, the TXA group shows a significant reduction in operation time.

The hemostatic and anti-inflammatory effects of intravenous single-dose of tranexamic acid in double-segment posterior lumbar interbody fusion: a case control study.

This study aims to observe the hemostatic and anti-inflammatory effects of intravenous administration of tranexamic acid (TXA) in dual segment posterior lumbar interbody fusion (PLIF). The data of 53 patients with lumbar disease treated with double-segment PLIF were included in this study. The observation group was received a single-dose intravenous of TXA (1 g/100 mL) 15 min before skin incision after general anesthesia. The control group was not received TXA. The observation indicators included postoperative activated partial prothrombin time (APTT), thrombin time (PT), thrombin time (TT), fibrinogen (FIB), platelets (PLT), and postoperative deep vein thrombosis in the lower limbs, surgical time, intraoperative bleeding volume, postoperative drainage volume, transfusion rate, postoperative hospital stay, red blood cell (RBC), hemoglobin (HB), hematocrit (HCT), C-reactive protein (CRP), and erythrocyte sedimentation rate (ESR) on the 1st, 4th, 7th, and last tested day after surgery. All patients successfully completed the operation, and there was no deep vein thrombosis after operation. There was no statistically significant difference in postoperative APTT, PT, TT, FIB, PLT, surgical time, and postoperative hospital stay between the two groups (p > 0.05). The intraoperative bleeding volume, postoperative drainage volume, and transfusion rate in the observation group were lower than those in the control group, and the differences were statistically significant (p < 0.05). There was no statistically significant difference in RBC, HB, HCT, CRP, and ESR between the two groups on the 1st, 4th, 7th, and last tested day after surgery (p > 0.05). Intravenous administration of TXA in dual segment PLIF does not affect coagulation function and can reduce bleeding volume, postoperative drainage volume, and transfusion rate. Moreover, it does not affect the postoperative inflammatory response.

Safety assessment of tranexamic acid: real-world adverse event analysis from the FAERS database.

Background: In recent years, with the continuous expansion of the application scope of Tranexamic acid (TXA), its usage has surged. Despite numerous studies demonstrating its powerful efficacy, concerns regarding its adverse reactions persist, necessitating comprehensive safety assessment. This study analyzed real-world data from the U.S. Food and Drug Administration to investigate TXA-related adverse events, aiming to elucidate its safety and optimize patient treatment. Methods: The adverse drug event data concerning TXA from 2004 Q1 to 2023 Q3 were collected. Following data standardization, a variety of signal quantification techniques, including the reporting odds ratios, proportional reporting ratios, Bayesian confidence propagation neural network, and empirical Bayes geometric mean were used for analysis. Results: After analyzing 16,692,026 adverse event reports, a total of 1,574 cases of adverse events related to TXA were identified, spanning 23 system organ classes and 307 preferred terms. In addition to the common thrombosis-related Vascular disorders (n = 386) and Cardiac disorders (n = 377), adverse reactions in the Nervous system disorders category were also observed (n = 785), including Myoclonus (n = 70), Status epilepticus (n = 43), and Myoclonic epilepsy (n = 17). Furthermore, this study uncovered adverse effects such as Renal cortical necrosis, Hepatic cyst rupture, and Vascular stent stenosis, which were not previously mentioned in the instructions. Although these occurred infrequently, they exhibited high signal strength. Both Retinal artery occlusion and Vascular stent thrombosis disorder were frequent and exhibited high signal strength as well. It is worth noting that 78 cases of adverse reactions were caused by confusion between incorrect product administration. Conclusion: Our research suggests that TXA has some adverse reactions that are being overlooked. As a cornerstone medication in hemorrhage treatment, it's crucial to monitor, identify, and address these adverse reactions effectively.

Therapeutic efficiency and safety assessment of intradermal platelet-rich plasma combined with oral tranexamic acid in patients with facial melasma.

BACKGROUND: Melasma is a chronic, acquired hypermelanosis that primarily affects the face. Platelet-rich plasma (PRP) and tranexamic acid (TXA) are promising treatments for melasma. However, only a few randomized clinical trials have examined the efficacy and safety of combining these therapies for melasma. OBJECTIVES: We aimed to compare the efficacy and safety of combining PRP and oral TXA with those of PRP alone in the treatment of facial melasma. MATERIAL AND METHODS: A randomized controlled trial was conducted at Walailak University Hospital, Nakhon Si Thammarat, Thailand, between March and September 2023. Participants with mixed-type melasma were randomly allocated in a 1:1 ratio to either group A (PRP injection alone without placebo) or group B (PRP injection with oral TXA). Therapeutic efficacy and safety assessments were performed over a 12-week follow-up period. RESULTS: The study included 26 participants (mean age: 45.9 years, standard deviation (±SD): 5.0) who were predominantly female (84.6%). In group A, the modified Melasma Area and Severity Index (mMASI) scores significantly decreased from a median of 4.30 interquartile range (IQR): 4.10) to 3.60 (IQR: 3.10) between week 0 and week 12, respectively. In group B, the median mMASI decreased from 6.40 (IQR: 7.80) to 3.60 (IQR: 3.70) over the same period. The median change in mMASI scores in group B (2.90, IQR: 2.40) was significantly larger than in group A (0.90, IQR: 0.60) (p < 0.001, U = 160.50). However, there were no significant differences in the physicians' global assessment (PGA), melasma quality of life scale (MelasQoL) or patient satisfaction during follow-up. Four patients (15.4%) experienced transient erythema and swelling. In group B, 1 participant (7.7%) experienced transient mild gastrointestinal discomfort after receiving oral TXA. CONCLUSIONS: The combination of intradermal PRP injection and oral TXA is effective for melasma, even in patients with poor prognostic treatment response factors. No serious adverse reactions were observed in either group.