Early Prehospital Tranexamic Acid Following Injury is Associated with a 30-day Survival Benefit: A Secondary Analysis of a Randomized Clinical Trial
Annals of surgery. 2021
OBJECTIVE We sought to characterize the timing of administration of prehospital Tranexamic Acid (TXA) and associated outcome benefits. BACKGROUND TXA has been shown to be safe in the prehospital setting post-injury. METHODS We performed a secondary analysis of a recent prehospital randomized TXA clinical trial in injured patients. Those who received prehospital TXA within 1hr (EARLY) from time of injury were compared to those who received prehospital TXA beyond 1hr (DELAYED). We included patients with a shock index of > 0.9. Primary outcome was 30-day mortality. Kaplan-Meier and Cox Hazard regression were utilized to characterize mortality relationships. RESULTS EARLY and DELAYED patients had similar demographics, injury characteristics and shock severity but DELAYED patients had greater prehospital resuscitation requirements and longer prehospital times. Stratified Kaplan-Meier analysis demonstrated significant separation for EARLY patients (N =238, log-rank chi-square test, 4.99; P = .03) with no separation for DELAYED patients (N=238, log-rank chi-square test, 0.04; P = .83). Stratified Cox Hazard regression verified, after controlling for confounders, that EARLY TXA was associated with a 65% lower independent hazard for 30-day mortality (HR 0.35, 95%CI 0.19-0.65, P = .001) with no independent survival benefit found in DELAYED patients (HR 1.00, 95%CI 0.63-1.59, P = .999). EARLY TXA patients had lower incidence of multiple organ failure and 6-hour and 24-hour transfusion requirements compared to placebo. CONCLUSIONS Administration of prehospital TXA within 1 hour from injury in patients at risk of hemorrhage is associated with 30-day survival benefit, lower incidence of multiple organ failure, and lower transfusion requirements.
Injured patients (n= 476).
Prehospital tranexamic acid (TXA) within 1 hour from time of injury (Early group, n= 238).
Prehospital TXA beyond 1 hour (Delayed group, n= 238).
Patients from both groups had similar demographics, injury characteristics and shock severity but those in the delayed group had greater prehospital resuscitation requirements and longer prehospital times. Stratified Kaplan-Meier analysis demonstrated significant separation for those in the early group (log-rank chi-square test, 4.99) with no separation for patients in the delayed group (log-rank chi-square test, 0.04). Stratified Cox Hazard regression verified, after controlling for confounders, that early TXA was associated with a 65% lower independent hazard for 30-day mortality (HR 0.35) with no independent survival benefit found in delayed patients (HR 1.00). Early TXA patients had lower incidence of multiple organ failure and 6-hour and 24-hour transfusion requirements.
A Systematic Review and Meta-Analysis Evaluating the Impact of Tranexamic Acid Administration in Aesthetic Plastic Surgery
Aesthetic surgery journal. 2021
BACKGROUND Recent evidence suggests tranexamic acid (TXA) may improve outcomes in aesthetic surgery patients. OBJECTIVES This systematic review aimed to investigate the impact of TXA use in aesthetic plastic surgery on bleeding and aesthetic outcomes. METHODS A systematic literature search was conducted to identify studies evaluating TXA use in aesthetic plastic surgery. The primary outcome of interest was perioperative bleeding, reported as total blood loss (TBL), ecchymosis, and hematoma formation. Meta-analyses analyzing TBL, and postoperative hematoma were performed. RESULTS Of 287 identified articles, 14 studies evaluating TXA use in rhinoplasty (6), rhytidectomy (3), liposuction (3), reduction mammaplasty (1), and blepharoplasty (1) were included for analysis. Of 820 total patients, 446 (54.4%) received TXA. Meta-analysis demonstrated TXA is associated with 26.3mL average blood loss reduction (95% CI: -40.0mL to -12.7mL, p < 0.001) and suggested a trend toward decreased odds of postoperative hematoma with TXA use (OR: 0.280, 95% CI: 0.076 - 1.029, p = 0.055). Heterogeneity among reporting of other outcomes precluded meta-analysis; however, 5 of 7 studies found significantly decreased postoperative ecchymosis levels within 7 days of surgery, three studies found statistically significant reductions in postoperative drain output, and one study reported significantly improved surgical site quality for patients who received TXA (p = 0.001). CONCLUSIONS TXA is associated with decreased blood loss and a trend toward decreased hematoma formation in aesthetic plastic surgery. Its use has the potential to increase patient satisfaction with postoperative recovery and decrease costs associated with complications, including hematoma evacuation.
The effect of tranexamic acid on blood loss in orthognathic surgery: a randomized, placebo-controlled, equivalence study
International journal of oral and maxillofacial surgery. 2021
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.
Is There a Role for Tranexamic Acid in Upper GI Bleeding? A Systematic Review and Meta-Analysis
Surgery research and practice. 2021;2021:8876991
INTRODUCTION Upper gastrointestinal (GI) bleeding is associated with increased morbidity and mortality. Tranexamic acid (TXA) is an antifibrinolytic agent which is licensed in the management of haemorrhage associated with trauma. It has been suggested that tranexamic acid may be able to play a role in upper GI bleeding. However, there is currently no recommendation to support this. AIM: The aim of this study was to synthesise available evidence of the effect of TXA on upper GI bleeding. METHODS AND MATERIALS A systematic review was conducted. PubMed, EMBASE, and Cochrane Central Register of Controlled Trials (CENTRAL) were searched for relevant studies. A random effects meta-analysis was performed to determine the risk ratio of primary and secondary outcomes pertaining to the use of TXA in upper GI bleeding. RESULTS A total of 8 studies were included in this systematic review. The total number of patients in all studies was 12994 including 4550 females (35%) and 8444 males (65%). The mean age of participants in 6 of the studies was 59.3; however the mean age for either intervention or placebo group was not reported in two of the studies. All studies reported on the effect of TXA on mortality, and the risk ratio was 0.95; however, with the 95% CI ranging from 0.80 to 1.13, this was not statistically significant. 6 of the studies reported on rebleeding rate, the risk ratio was 0.64, and with a 95% CI ranging from 0.47 to 0.86, this was statistically significant. 3 of the studies reported on the risk of adverse thromboembolic events, and the risk ratio was 0.93; however, the 95% CI extended from 0.62 to 1.39 and so was not statistically significant. 7 of the studies reported on the need for surgery, and the risk ratio was 0.59 and was statistically significant with a 95% CI ranging from 0.38 to 0.94. CONCLUSION In conclusion, the use of TXA in upper GI bleeding appears to have a beneficial effect in terms of decreasing the risk of re-bleeding and decreasing the need for surgery. However, we could not find a statistically significant effect on need for blood transfusions, risk of thromboembolic events, or effect on mortality. Future randomised controlled trials may elucidate these outcomes.
Patients with upper gastrointestinal (GI) bleeding (8 studies, n= 12,994).
Meta-analysis to synthesise available evidence of the effect of tranexamic acid (TXA) on upper GI bleeding.
All studies reported on the effect of TXA on mortality, and the risk ratio was 0.95; however, this was not statistically significant. 6 of the studies reported on rebleeding rate, the risk ratio was 0.64, and this was statistically significant. 3 of the studies reported on the risk of adverse thromboembolic events, and the risk ratio was 0.93; however, was not statistically significant. 7 of the studies reported on the need for surgery, and the risk ratio was 0.59 and was statistically significant.
Efficacy and Safety of Tranexamic Acid for the Control of Surgical Bleeding in Patients Under Liposuction
Aesthetic plastic surgery. 2021
Liposuction remains one of the most frequently performed cosmetic surgical procedures and its popularity is increasing every year. However, since its inception, justified concerns regarding patient safety have placed limits on the volume of fat that can be aspirated, influenced by hemodynamic fluctuations and blood loss during liposuction. Tranexamic acid (TXA) is an antifibrinolytic agent that competitively inhibits the conversion of plasminogen to plasmin, thus preventing the binding and degradation of fibrin. Despite the existence of evidence of the effectiveness of TXA in orthopedic and cardiac surgeries, there is little evidence of its use in liposuction. The objective of this study was to evaluate the efficacy and safety of tranexamic acid in the control of surgical bleeding in patients undergoing liposuction, through a prospective, open, randomized and controlled clinical trial. Two groups of 25 participants each were formed to whom the application of TXA in a tumescent solution prior to liposuction or liposuction with the traditional technique was randomly assigned. The results showed a decrease in blood loss reflected by the differences in the final hematocrit values, as well as decrease in the same per aspirated volume (p = 0.003). No adverse events were found related with the TXA application and no blood transfusions were required in this group, in contrast to the control group where the need for blood transfusion was present in 20% of the intervened participants. 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.
Evaluation of local tranexamic acid on septoplastic surgery quality
Journal of plastic, reconstructive & aesthetic surgery : JPRAS. 2021
BACKGROUND Even a small amount of bleeding during nose surgery can impair the surgeon's vision, prolong the duration of operation, and affect surgery quality; therefore, various techniques have been proposed to control the bleeding. The aim of this study was to compare the efficacy of the local use of tranexamic acid (TXA) in the dry field of surgery. METHOD This randomized, double-blinded, controlled trial was conducted in the operation room of Imam Reza Hospital, Tehran, Iran, from January 10, 2016 to February 8, 2017. Sixty patients with age range from 20 to 60 years and the American Society of Anesthesiologists physical status classes I candidates who require septoplasty enrolled. Patients were randomized through white and black cards to receive either syringes. Thirty patients in the intervention group received lidocaine + adrenaline + TXA and 30 patients in the control group received lidocaine + adrenaline. Bleeding volume accumulated in the suction chamber, the nasopharyngeal pack, and hemodynamic variations were measured. Surgeon's satisfaction scores and suitability of operation field were obtained from the surgeon by using the Likert scale and Boezaart grading scale, respectively. RESULTS The intervention group had a higher score of surgeon satisfaction [4.1 vs 3.16 in the control group (P = 0.001)] and fewer hemodynamic variations. The mean bleeding volume in the intervention was 187.23 ± 54.61 mL and in the control group was 341.22 ± 49.17 mL (P = 0.001). The mean Boezaart score (suitability of operation field) in the intervention group was 1.8 (score range: 1-3) and in the control group was 2.53 (score range: 2-4) and it was statistically significant (P = 0.001). CONCLUSION The local use of TXA + lidocaine + adrenaline is associated with reduced bleeding, greater surgeon satisfaction, reduced need for Karpol injection, and better hemodynamic stability.
Inconclusive evidence for the efficacy of tranexamic acid in reducing transfusions, postoperative infection or hematoma formation after primary shoulder arthroplasty: A meta-analysis with trial sequential analysis
Shoulder & elbow. 2021;13(1):38-50
BACKGROUND Tranexamic acid efficacy on clinically relevant adverse outcomes in patients undergoing shoulder arthroplasty has been contradictory. The aim of this review was to analyze whether tranexamic acid administration could decrease transfusions, infection and hematoma formation in patients undergoing shoulder arthroplasty. METHODS PubMed, EMBASE, and the Cochrane Library were searched up to May 2019 for randomized controlled trials comparing tranexamic acid to placebo in shoulder arthroplasty. Random-effect models were performed to meta-analyze the evidence. Trial sequential analysis was used to calculate and to establish the conclusiveness of the evidence derived from the meta-analysis. RESULTS Four randomized controlled trials comprising 375 patients were included. Meta-analysis showed no effect of tranexamic acid on transfusion rate (RR = 0.48 (adjusted 95% CI 0.05 to 3.85)). The possible effect of tranexamic acid on hematoma formation or infection rates after shoulder arthroplasty is non-estimable with the current evidence. The sample size necessary to reliably determine if tranexamic acid decreases transfusions, infection rates and hematoma formation is not available from the current literature as determined by the trial sequential analysis. DISCUSSION While tranexamic acid has proven its efficacy in decreasing blood loss in shoulder arthroplasty, this meta-analysis of randomized controlled trials clarifies that there is currently no conclusive evidence for a positive effect of tranexamic acid upon transfusion rate, infection rates or hematoma formation in patients undergoing primary shoulder arthroplasty.
Complications of Tranexamic Acid in Orthopedic Lower Limb Surgery: A Meta-Analysis of Randomized Controlled Trials
BioMed research international. 2021;2021:6961540
OBJECTIVE Tranexamic acid (TXA) is increasingly used in orthopedic surgery to reduce blood loss; however, there are concerns about the risk of venous thromboembolic (VTE) complications. The aim of this study was to evaluate TXA safety in patients undergoing lower limb orthopedic surgical procedures. DESIGN A meta-analysis was performed on the PubMed, Web of Science, and Cochrane Library databases in January 2020 using the following string (Tranexamic acid) AND ((knee) OR (hip) OR (ankle) OR (lower limb)) to identify RCTs about TXA use in patients undergoing every kind of lower limb surgical orthopedic procedures, with IV, IA, or oral administration, and compared with a control arm to quantify the VTE complication rates. RESULTS A total of 140 articles documenting 9,067 patients receiving TXA were identified. Specifically, 82 studies focused on TKA, 41 on THA, and 17 on other surgeries, including anterior cruciate ligament reconstruction, intertrochanteric fractures, and meniscectomies. The intravenous TXA administration protocol was studied in 111 articles, the intra-articular in 45, and the oral one in 7 articles. No differences in terms of thromboembolic complications were detected between the TXA and control groups neither in the overall population (2.4% and 2.8%, respectively) nor in any subgroup based on the surgical procedure and TXA administration route. CONCLUSIONS There is an increasing interest in TXA use, which has been recently broadened from the most common joint replacement procedures to the other types of surgeries. Overall, TXA did not increase the risk of VTE complications, regardless of the administration route, thus supporting the safety of using TXA for lower limb orthopedic surgical procedures.
Use of tranexamic acid does not influence perioperative outcomes in ambulatory foot and ankle surgery-a prospective triple blinded randomized controlled trial
International orthopaedics. 2021
STUDY OBJECTIVE TXA is an antifibrinolytic medication widely used to reduce perioperative blood loss, but it has been seldom used during foot and ankle surgery. Our study evaluates the impact of TXA use on blood loss, post-operative pain, peri-operative opioid consumption, and wound healing in ambulatory outpatient foot and ankle procedures. DESIGN Prospective, triple-blinded, randomized controlled trial. SETTING Peri-operative environment of a major academic health centre in New York City. PATIENTS A total of 100 participants who were scheduled for ambulatory foot and ankle surgery with a single surgeon. INTERVENTIONS Patients receive either 10 mg/kg TXA (TXA group) or 10 ml/kg of normal saline (placebo group) intravenously prior to skin incision. MEASUREMENTS Primary outcome was intra-operative blood loss. Secondary outcomes were peri-operative opioid consumption and wound complications between post-operative days 14 and 21. MAIN RESULTS We found no difference between TXA and placebo groups in terms of intra-operative blood loss, p value 0.71, 95% CI (63.13-19.80). There was no difference between the two groups in terms of post-operative morphine milliequivalents (MME). The incidence of wound complications was 16.3% in the TXA group compared to 15.7% in the placebo group with OR 1.04, p value 0.93, 95% CI (0.32-2.77). No adverse events associated with TXA were reported. CONCLUSIONS The use of TXA during foot and ankle surgery was not associated with any benefits in perioperative outcomes in our outpatient ambulatory surgical population. Considering potential risks, we do not support the routine use of TXA in this surgical model.
Tranexamic Acid for the Prevention of Blood Loss after Cesarean Delivery
The New England journal of medicine. 2021;384(17):1623-1634
BACKGROUND Prophylactic administration of tranexamic acid has been associated with reduced postpartum blood loss after cesarean delivery in several small trials, but evidence of its benefit in this clinical context remains inconclusive. METHODS In a multicenter, double-blind, randomized, controlled trial, we assigned women undergoing cesarean delivery before or during labor at 34 or more gestational weeks to receive an intravenously administered prophylactic uterotonic agent and either tranexamic acid (1 g) or placebo. The primary outcome was postpartum hemorrhage, defined as a calculated estimated blood loss greater than 1000 ml or receipt of a red-cell transfusion within 2 days after delivery. Secondary outcomes included gravimetrically estimated blood loss, provider-assessed clinically significant postpartum hemorrhage, use of additional uterotonic agents, and postpartum blood transfusion. RESULTS Of the 4551 women who underwent randomization, 4431 underwent cesarean delivery, 4153 (93.7%) of whom had primary outcome data available. The primary outcome occurred in 556 of 2086 women (26.7%) in the tranexamic acid group and in 653 of 2067 (31.6%) in the placebo group (adjusted risk ratio, 0.84; 95% confidence interval [CI], 0.75 to 0.94; P = 0.003). There were no significant between-group differences in mean gravimetrically estimated blood loss or in the percentage of women with provider-assessed clinically significant postpartum hemorrhage, use of additional uterotonic agents, or postpartum blood transfusion. Thromboembolic events in the 3 months after delivery occurred in 0.4% of women (8 of 2049) who received tranexamic acid and in 0.1% of women (2 of 2056) who received placebo (adjusted risk ratio, 4.01; 95% CI, 0.85 to 18.92; P = 0.08). CONCLUSIONS Among women who underwent cesarean delivery and received prophylactic uterotonic agents, tranexamic acid treatment resulted in a significantly lower incidence of calculated estimated blood loss greater than 1000 ml or red-cell transfusion by day 2 than placebo, but it did not result in a lower incidence of hemorrhage-related secondary clinical outcomes. (Funded by the French Ministry of Health; TRAAP2 ClinicalTrials.gov number, NCT03431805.).