Importance Tranexamic acid (TXA) is an efficient antifibrinolytic agent; however, concerns remain about the potential adverse effects, particularly vascular occlusive events, that may be associated with its use. Objective To examine the association between intravenous TXA and total thromboembolic events (TEs) and mortality in patients of all ages and of any medical disciplines. Data source Cochrane Central Register of Controlled Trials and MEDLINE were searched for eligible studies investigating intravenous TXA and postinterventional outcome published between 1976 and 2020. Study selection Randomized clinical trials comparing intravenous TXA with placebo/no treatment. The electronic database search yielded a total of 782 studies, and 381 were considered for full-text review. Included studies were published in English, German, French, and Spanish. Studies with only oral or topical tranexamic administration were excluded. Data extraction and synthesis Meta-analysis, subgroup and sensitivity analysis, and meta-regression were performed. This study followed the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guideline. Main outcomes and measures Vascular occlusive events and mortality. Results A total of 216 eligible trials including 125 550 patients were analyzed. Total TEs were found in 1020 (2.1%) in the group receiving TXA and 900 (2.0%) in the control group. This study found no association between TXA and risk for total TEs (risk difference = 0.001; 95% CI, -0.001 to 0.002; P = .49) for venous thrombosis, pulmonary embolism, venous TEs, myocardial infarction or ischemia, and cerebral infarction or ischemia. Sensitivity analysis using the risk ratio as an effect measure with (risk ratio = 1.02; 95% CI, 0.94-1.11; P = .56) and without (risk ratio = 1.03; 95% CI, 0.95-1.12; P = .52) studies with double-zero events revealed robust effect size estimates. Sensitivity analysis with studies judged at low risk for selection bias showed similar results. Administration of TXA was associated with a significant reduction in overall mortality and bleeding mortality but not with nonbleeding mortality. In addition, an increased risk for vascular occlusive events was not found in studies including patients with a history of thromboembolism. Comparison of studies with sample sizes of less than or equal to 99 (risk difference = 0.004; 95% CI, -0.006 to 0.014; P = .40), 100 to 999 (risk difference = 0.004; 95% CI, -0.003 to 0.011; P = .26), and greater than or equal to 1000 (risk difference = -0.001; 95% CI, -0.003 to 0.001; P = .44) showed no association between TXA and incidence of total TEs. Meta-regression of 143 intervention groups showed no association between TXA dosing and risk for venous TEs (risk difference, -0.005; 95% CI, -0.021 to 0.011; P = .53). Conclusions and relevance Findings from this systematic review and meta-analysis of 216 studies suggested that intravenous TXA, irrespective of dosing, is not associated with increased risk of any TE. These results help clarify the incidence of adverse events associated with administration of intravenous TXA and suggest that TXA is safe for use with undetermined utility for patients receiving neurological care.

/pdf/association-of-intravenous-tranexamic-acid-with-f2m943fzir.pdf

Association of Intravenous Tranexamic Acid With Thromboembolic Events and Mortality: A Systematic Review, Meta-analysis, and Meta-regression.

Background A growing body of published research on tranexamic acid (TXA) suggests that it is effective in reducing blood loss and the risk for transfusion in total knee arthroplasty (TKA). The purpose of this network meta-analysis was to evaluate TXA in primary TKA as the basis for the efficacy recommendations of the combined clinical practice guidelines of the American Association of Hip and Knee Surgeons, American Academy of Orthopaedic Surgeons, Hip Society, Knee Society, and American Society of Regional Anesthesia and Pain Medicine on the use of TXA in primary total joint arthroplasty. Methods We searched Ovid MEDLINE, Embase, Cochrane Reviews, Scopus, and Web of Science databases for publications before July 2017 on TXA in primary total joint arthroplasty. All included studies underwent qualitative and quantitative homogeneity testing. Direct and indirect comparisons were performed as a network meta-analysis, and results were tested for consistency. Results After critical appraisal of the available 2113 publications, 67 articles were identified as representing the best available evidence. Topical, intravenous (IV), and oral TXA formulations were all superior to placebo in terms of decreasing blood loss and risk of transfusion, while no formulation was clearly superior. Use of repeat IV and oral TXA dosing and higher doses of IV and topical TXA did not significantly reduce blood loss or risk of transfusion. Preincision administration of IV TXA had inconsistent findings with a reduced risk of transfusion but no effect on volume of blood loss. Conclusions Strong evidence supports the efficacy of TXA to decrease blood loss and the risk of transfusion after primary TKA. No TXA formulation, dosage, or number of doses provided clearly improved blood-sparing properties for TKA. Moderate evidence supports preincision administration of IV TXA to improve efficacy.

The Efficacy of Tranexamic Acid in Total Knee Arthroplasty: A Network Meta-Analysis.

Background Tranexamic acid (TXA) is an antifibrinolytic agent commonly used to reduce blood loss in total hip arthroplasty (THA). The purpose of our study was to evaluate the efficacy of TXA in primary THA to support the combined clinical practice guidelines of the American Association of Hip and Knee Surgeons, American Academy of Orthopaedic Surgeons, Hip Society, Knee Society, and American Society of Regional Anesthesia and Pain Medicine on the use of TXA in primary total joint arthroplasty. Methods A search was performed using Ovid-MEDLINE, Embase, Cochrane Reviews, Scopus, and Web of Science databases to identify all publications before July 2017 on TXA in primary THA. We completed qualitative and quantitative homogeneity testing of all included studies. Direct and indirect comparisons were analyzed using a network meta-analysis followed by consistency testing of the results. Results Two thousand one hundred thirteen publications underwent critical appraisal with 34 publications identified as representing the best available evidence for inclusion in the analysis. Topical, intravenous, and oral TXA formulations provided reduced blood loss and risk of transfusion compared to placebo, but no formulation was clearly superior. Use of repeat doses, higher doses, or variation in timing of administration did not significantly reduce blood loss or risk of transfusion. Conclusions Strong evidence supports the use of TXA to reduce blood loss and risk of transfusion after primary THA. No specific routes of administration, dosage, dosing regimen, or time of administration provides clearly superior blood-sparing properties.

The Efficacy of Tranexamic Acid in Total Hip Arthroplasty: A Network Meta-analysis.

Total knee arthroplasty (TKA) often causes a significant amount of blood loss with an accompanying decline in hemoglobin and may increase the frequency of allogeneic blood transfusion rates. Unfortunately, allogeneic blood transfusions have associated risks including postoperative confusion, infection, cardiac arrhythmia, fluid overload, increased length of hospital stay, and increased mortality. Other than reducing the need for blood transfusions, reducing perioperative blood loss in TKA may also minimize intra-articular hemorrhage, limb swelling, and postoperative pain, and increase the range of motion during the early postoperative period. These benefits improve rehabilitation success and increase patients' postoperative satisfaction. Preoperative anemia, coupled with intraoperative and postoperative blood loss, is a major factor associated with higher rates of blood transfusion in TKA. Thus, treatment of preoperative anemia and prevention of perioperative blood loss are the primary strategies for perioperative blood management in TKA. This review, combined with current evidence, analyzes various methods of blood conservation, including preoperative, intraoperative, and postoperative methods, in terms of their effectiveness, safety, and cost. Because many factors can be controlled to reduce blood loss and transfusion rates in TKA, a highly efficient, safe, and cost-effective blood management strategy can be constructed to eliminate the need for transfusions associated with TKA.

https://onlinelibrary.wiley.com/doi/pdf/10.1111/os.12361

Perioperative Blood Management Strategies for Total Knee Arthroplasty.

Total knee replacement (TKR) is one of the most common surgeries over the last decade. Patients undergoing TKR are at high risk for postoperative anemia and furthermore for allogeneic blood transfusions (ABT). Complications associated with ABT including chills, rigor, fever, dyspnea, light-headedness should be early recognized in order to lead to a better prognosis. Therefore, perioperative blood management program should be adopted with main aim to reduce the risk of blood transfusion while maximizing hemoglobin simultaneously. Many blood conservation strategies have been attempted including preoperative autologous blood donation, acute normovolemic haemodilution, autologous blood transfusion, intraoperative cell saver, drain clamping, pneumatic tourniquet application, and the use of tranexamic acid. For practical and clinical reasons we will try to classify these strategies in three main stages/pillars: Pre-operative optimization, intra-operative and post-operative protocols. The aim of this work is review the strategies currently in use and reports our experience regarding the perioperative blood management strategies in TKR.

Perioperative blood management strategies for patients undergoing total knee replacement: Where do we stand now?

Background: Postoperative blood loss in patients after total knee arthroplasty may cause local and systemic complications and influence clinical outcome. The aim of this study was to assess whether fibrin glue or tranexamic acid reduced blood loss compared with routine hemostasis in patients undergoing total knee arthroplasty.

Methods: A randomized, single-center, parallel, open clinical trial was performed in adult patients undergoing primary total knee arthroplasty. Patients were divided into four groups. Group 1 received fibrin glue manufactured by the Blood and Tissue Bank of Catalonia, Group 2 received Tissucol (fibrinogen and thrombin), Group 3 received intravenous tranexamic acid, and Group 4 (control) had no treatment other than routine hemostasis. The primary outcome was total blood loss collected in drains after surgery. Secondary outcomes were the calculated hidden blood loss, transfusion rate, preoperative and postoperative hemoglobin, number of blood units transfused, adverse events, and mortality.

Results: One hundred and seventy-two patients were included. The mean total blood loss (and standard deviation) collected in drains was 553.9 ± 321.5 mL for Group 1, 567.8 ± 299.3 mL for Group 2, 244.1 ± 223.4 mL for Group 3, and 563.5 ± 269.7 mL for Group 4. In comparison with the control group, Group 3 had significantly lower total blood loss (p < 0.001), but it was not significantly lower in Groups 1 and 2. The overall rate of patients who had a blood transfusion was 21.1% (thirty-five of 166 patients analyzed per protocol). Two patients required transfusion in Group 3 compared with twelve patients in Group 4 (p = 0.015). No significant difference was observed between the two fibrin glue groups and the control group with regard to the need for transfusion. There was no difference between groups with regard to the percentage of adverse events.

Conclusions: Neither type of fibrin glue was more effective than routine hemostasis in reducing postoperative bleeding and transfusion requirements, and we no longer use them. However, this trial supports findings from previous studies showing that intravenous tranexamic acid can decrease postoperative blood loss.

Level of Evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Efficacy and safety of fibrin glue and tranexamic acid to prevent postoperative blood loss in total knee arthroplasty: a randomized controlled clinical trial.

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Efficacy and safety of fibrin glue and tranexamic acid to prevent postoperative blood loss in total knee arthroplasty: a randomized controlled clinical trial.