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BMJ Open Jun 2024Tranexamic acid (TXA) is an inexpensive and widely available medication that reduces blood loss and red blood cell (RBC) transfusion in cardiac and orthopaedic... (Randomized Controlled Trial)
Randomized Controlled Trial
INTRODUCTION
Tranexamic acid (TXA) is an inexpensive and widely available medication that reduces blood loss and red blood cell (RBC) transfusion in cardiac and orthopaedic surgeries. While the use of TXA in these surgeries is routine, its efficacy and safety in other surgeries, including oncologic surgeries, with comparable rates of transfusion are uncertain. Our primary objective is to evaluate whether a hospital-level policy implementation of routine TXA use in patients undergoing major non-cardiac surgery reduces RBC transfusion without increasing thrombotic risk.
METHODS AND ANALYSIS
A pragmatic, registry-based, blinded, cluster-crossover randomised controlled trial at 10 Canadian sites, enrolling patients undergoing non-cardiac surgeries at high risk for RBC transfusion. Sites are randomised in 4-week intervals to a hospital policy of intraoperative TXA or matching placebo. TXA is administered as 1 g at skin incision, followed by an additional 1 g prior to skin closure. Coprimary outcomes are (1) effectiveness, evaluated as the proportion of patients transfused RBCs during hospital admission and (2) safety, evaluated as the proportion of patients diagnosed with venous thromboembolism within 90 days. Secondary outcomes include: (1) transfusion: number of RBC units transfused (both at a hospital and patient level); (2) safety: in-hospital diagnoses of myocardial infarction, stroke, deep vein thrombosis or pulmonary embolism; (3) clinical: hospital length of stay, intensive care unit admission, hospital survival, 90-day survival and the number of days alive and out of hospital to day 30; and (4) compliance: the proportion of enrolled patients who receive a minimum of one dose of the study intervention.
ETHICS AND DISSEMINATION
Institutional research ethics board approval has been obtained at all sites. At the completion of the trial, a plain language summary of the results will be posted on the trial website and distributed in the lay press. Our trial results will be published in a peer-reviewed scientific journal.
TRIAL REGISTRATION NUMBER
NCT04803747.
Topics: Humans; Tranexamic Acid; Antifibrinolytic Agents; Canada; Blood Loss, Surgical; Cross-Over Studies; Erythrocyte Transfusion; Organizational Policy
PubMed: 38830735
DOI: 10.1136/bmjopen-2024-084847 -
EFORT Open Reviews Jun 2024This 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...
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.
PubMed: 38828967
DOI: 10.1530/EOR-23-0140 -
Orthopaedic Surgery Jun 2024Total hip arthroplasty (THA) effectively treats end-stage hemophilic hip arthropathy. Given hemophilia's unique characteristics, perioperative bleeding remains a...
OBJECTIVE
Total hip arthroplasty (THA) effectively treats end-stage hemophilic hip arthropathy. Given hemophilia's unique characteristics, perioperative bleeding remains a significant risk for patients undergoing THA. Tranexamic acid (TXA), an efficient antifibrinolytic agent, may benefit the outcomes of THA for patients with hemophilia (PWH). This study aims to explore the clinical efficacy of intra-articular injection of TXA in treating perioperative bleeding in PWH and assess its additional clinical benefits.
METHODS
The retrospective study comprised data of PWH who received THA from January 2015 to December 2021 in the research center. A total of 59 individuals were included in the study, divided into a TXA group (n = 31) and a non-TXA group (n = 28). We compared various parameters, including total blood loss (TBL), visible blood loss (VBL), occult blood loss (OBL), intraoperative coagulation factor VIII (FVIII) consumption, perioperative total FVIII consumption, hemoglobin (HB), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), length of hospital stay, hospitalization costs, length of surgery, total protein, activated partial thromboplastin time (APTT), D-dimer, rate of joint swelling, hip joint range of motion (ROM), visual analogue scale (VAS), and Harris hip joint function scale (HHS) between the two groups. Follow-up assessments were conducted for up to 24 months. A Student's t test was utilized for the statistical analysis.
RESULTS
This study demonstrated that intra-articular TXA effectively reduced TBL (1248.19 ± 439.88 mL, p < 0.001), VBL (490.32 ± 344.34 mL, p = 0.003), and OBL (757.87 ± 381.48 mL, p = 0.004) in PWH who underwent THA. TXA demonstrated effectiveness in reducing VAS scores on POD1, POD7, and POD14 and joint swelling rates on POD1, POD7, POD14, and at discharge (p < 0.05). Additionally, the TXA group achieved higher HHS ratings at all follow-up time points (p < 0.05), showing superior hip joint mobility, lower postoperative inflammation levels, reduced factor VIII consumption during surgery, and less postoperative nutritional loss. No statistically significant differences were observed between the two groups in terms of hospital stay, hospitalization costs, surgery duration, and coagulation indicators.
CONCLUSION
Intra-articular injection of TXA reduces perioperative bleeding in PWH undergoing THA while also improving joint mobility, post-operative rehabilitation, and quality of life. This may provide value for the future application of TXA in PWH.
PubMed: 38828803
DOI: 10.1111/os.14126 -
Therapeutics and Clinical Risk... 2024Percutaneous endoscopic transforaminal lumbar interbody fusion (PE-TLIF) has become one of the most popular minimally invasive surgeries today. However, the issue of...
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.
PubMed: 38827486
DOI: 10.2147/TCRM.S462784 -
The Journal of Emergency Medicine Jul 2024Sexual assault survivors may sustain vaginal trauma that requires intervention in the emergency department, or operating room.
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.
Topics: Humans; Tranexamic Acid; Female; Adolescent; Lacerations; Administration, Topical; Antifibrinolytic Agents; Vagina; Sex Offenses; Hemorrhage; Emergency Service, Hospital
PubMed: 38825529
DOI: 10.1016/j.jemermed.2024.03.009 -
Urology May 2024
PubMed: 38825078
DOI: 10.1016/j.urology.2024.05.028 -
Blood May 2024Interplay between platelets, coagulation factors, endothelial cells (ECs) and fibrinolytic factors is necessary for effective hemostatic plug formation. This study...
Interplay between platelets, coagulation factors, endothelial cells (ECs) and fibrinolytic factors is necessary for effective hemostatic plug formation. This study describes a four-dimensional (4D) imaging platform to visualize and quantify hemostatic plug components in mice with high spatiotemporal resolution. Fibrin accumulation following laser-induced vascular injury was observed at the platelet plug-EC interface, controlled by the antagonistic balance between fibrin generation and breakdown. We observed less fibrin accumulation in mice expressing low levels of tissue factor (TFlow) or F12-/- mice compared to controls, whereas increased fibrin accumulation, including on the vasculature adjacent to the platelet plug, was observed in plasminogen-deficient mice or wild-type mice treated with tranexamic acid (TXA). Phosphatidylserine (PS), a membrane lipid critical for the assembly of coagulation factors, was first detected at the platelet plug-EC interface, followed by exposure across the endothelium. Impaired PS exposure resulted in a significant reduction in fibrin accumulation in cyclophilin D-/- mice. Adoptive transfer studies demonstrated a key role for PS exposure on platelets, and to a lesser degree on ECs, in fibrin accumulation during hemostatic plug formation. Together, these studies suggest that (1) platelets are the functionally dominant procoagulant cellular surface, and (2) plasmin is critical for limiting fibrin accumulation at the site of a forming hemostatic plug.
PubMed: 38820498
DOI: 10.1182/blood.2023022608 -
Musculoskeletal Surgery May 2024Spine surgeries are associated with significant blood loss due to the extensive soft tissue dissection, bony decompression, and prolonged surgical time. Excessive...
Spine surgeries are associated with significant blood loss due to the extensive soft tissue dissection, bony decompression, and prolonged surgical time. Excessive bleeding may require blood transfusions and thereby increase the risk of adverse transfusion reactions. Therefore, minimizing peri-operative bleeding is important for spine surgeons to reduce post-operative morbidity. Tranexamic acid (TXA) is a synthetic anti-fibrinolytic drug, which helps in reducing perioperative blood loss in major surgeries. The evidence on the efficacy of this agent in all manner of spine surgeries is not sufficient. Hence this study was conducted to determine the efficacy of TXA on perioperative blood loss in major spinal surgeries. In a prospective study, two groups of patients with similar surgical profiles who were posted for all manner of open spine surgeries were included. One group received one gram of intravenous TXA while the others did not. Intra- and post-operative assessments included noting levels of surgery, duration of surgery, assessment of blood loss, intra- and/or post- operative blood transfusion, and blood collected in surgical drain at the end of 24 h. The intra-operative blood loss, frequency of intra-operative blood transfusion, post-operative Hemoglobin drop, and surgical drain output were found to be significantly lower in patients who received TXA. In spine surgeries, TXA was found to be effective in reducing intra-operative blood loss, need for intra-operative blood transfusion and post-operative Hb drop. Also, TXA had reduced surgical drain output significantly between the two groups.
PubMed: 38819771
DOI: 10.1007/s12306-024-00826-0 -
European Journal of Trauma and... May 2024Despite the availability of clinical guidelines for hip fracture patients, adherence to these guidelines is challenging, potentially resulting in suboptimal patient...
PURPOSE
Despite the availability of clinical guidelines for hip fracture patients, adherence to these guidelines is challenging, potentially resulting in suboptimal patient care. The goal of this study was (1) to evaluate and benchmark the adherence to recently established quality indicators (QIs), and (2) to study clinical outcomes, in fragile hip fracture patients from different European countries.
METHODS
This observational, cross-sectional multicenter study was performed in 10 hospitals from 9 European countries including data of 298 consecutive patients.
RESULTS
A large variation both within and between hospitals were seen regarding adherence to the individual QIs. QIs with the lowest overall adherence rates were the administration of systemic steroids (5.4%) and tranexamic acid (20.1%). Indicators with the highest adherence rates (above 95%) were pre-operative (99.3%) and post-operative haemoglobin level assessment (100%). The overall median time to surgery was 22.6 h (range 15.7-42.5 h). The median LOS was 9.0 days (range 5.0-19.0 days). The most common complications were delirium (23.2%) and postsurgical constipation (25.2%).
CONCLUSION
The present study shows large variation in the care for fragile patients with hip fractures indicating room for improvement. Therefore, hospitals should invest in benchmarking and knowledge-sharing. Large quality improvement initiatives with longitudinal follow up of both process and outcome indicators should be initiated.
PubMed: 38819678
DOI: 10.1007/s00068-024-02549-0 -
Archives of Orthopaedic and Trauma... May 2024Many different regimes of intravenous and local tranexamic acid (TXA) reduce total blood loss (TBL) in patients undergoing total knee arthroplasty (TKA). However, the...
BACKGROUND
Many different regimes of intravenous and local tranexamic acid (TXA) reduce total blood loss (TBL) in patients undergoing total knee arthroplasty (TKA). However, the most effective TXA regime in reducing blood loss might not be most beneficial for the patient. The aim of the present study was to investigate the effect of commonly used TXA regimes on blood loss and on early clinical outcomes.
METHODS
We performed this monocentric retrospective study in patients undergoing primary TKA. Primary outcome was the estimated TBL. Secondary outcomes were the rates of adverse events (AE) as well as the range of motion (ROM), mobility and pain intensity during the first three physiotherapy sessions (PTS).
RESULTS
We analysed the data of 1250 TKAs. 5 different TXA regimes were applied. TBL (mean ± SE) was 953 ± 64 ml (2xiv), 999 ± 19 ml (2xiv + 1xlocal), 1075 ± 19 ml (1xiv + 1xlocal), 1191 ± 39 ml (1xlocal) and 1241 ± 48 ml (1xiv) (p < 0.01). In the linear regression model for TBL a lower number of TXA applications was a predictor for increased blood loss (p < 0.01). AE rates were lowest under 2xiv (0%) and 2xiv + 1xlocal (4.8%). Highest mobility and lowest pain intensity were observed under 1x iv and 2x iv. The largest portions of fully mobile patients on day three were observed under 1xiv (100%), 2xiv (100%) and 2xiv + 1local TXA (86.9%).
CONCLUSION
Our results suggest that multiple applications of TXA are more effective in decreasing blood loss than excessive dosing of TXA. Interestingly, local use of TXA might be associated with higher pain intensity and decreased mobility on the first days after surgery.
PubMed: 38819459
DOI: 10.1007/s00402-024-05229-1