Systemic tranexamic acid can decrease blood loss and rates of transfusion in patients undergoing total hip arthroplasty (THA). However, the efficacy of topical tranexamic acid in THA has only recently been characterized in a small number of studies. The purpose of this study was to compare (1) the greatest hemoglobin decrease after surgery; (2) transfusion rates; and (3) symptomatic thromboembolic events among patients undergoing THA who did and did not receive topical tranexamic acid. We retrospectively compared 135 patients (154 THAs) who received 10 mL 5% tranexamic acid added in a topical cocktail solution during surgery between January 2009 and July 2011 with 211 patients (234 THAs) who received only the topical cocktail solution (analgesic and antibiotic agent) between January 2005 and December 2008. Contraindications for the use of tranexamic acid included a documented history of a venous thromboembolic event, an allergy to tranexamic acid, thrombophilia, or a high risk of venous thromboembolism based on the guidelines of the American Academy of Orthopaedic Surgeons; the 135 patients who received it during that period represented 99.4% of the patients undergoing THA during that time. We compared changes in Hb, transfusion rates, estimated blood loss, surgical results, and complications between the groups. The transfusion threshold was the same, when the Hb values were < 10 g/dL. Patients were screened for thromboembolic disease if symptoms or signs appeared. Hb decreased less in the tranexamic acid group (1.87 ± 1.10 g/dL) than in the control group (2.2 ± 1.36 g/dL; p = 0.01) on the first postoperative day. The frequency of transfusion was lower in patients receiving tranexamic acid (17% as compared with 35% in the control group; p < 0.001). There was only one nonfatal pulmonary embolism in the control group during the study period. Use of topical tranexamic acid in patients undergoing THA reduces postoperative bleeding and decreases blood transfusion rates. No increase in major complications was identified in patients managed with topical tranexamic acid. This retrospective study confirms the results of a smaller randomized trial on the same topic by another group. Level III, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.
Objectives: To investigate the safety, feasibility, and possible adverse events of single-dose human umbilical cord-derived mesenchymal stem cells in patients with moderate-to-severe acute respiratory distress syndrome. Design: Prospective phase I clinical trial. Setting: Medical center in Kaohsiung, Taiwan. Patients: Moderate-to-severe acute respiratory distress syndrome with a Pao 2/Fio 2 ratio less than 200. Interventions: Scaling for doses was required by Taiwan Food and Drug Administration as follows: the first three patients received low-dose human umbilical cord-derived mesenchymal stem cells (1.0 × 106 cells/kg), the next three patients with intermediate dose (5.0 × 106 cells/kg), and the final three patients with high dose (1.0 × 107 cells/kg) between December 2017 and August 2019. Measurements and Main Results: Nine consecutive patients were enrolled into the study. In-hospital mortality was 33.3% (3/9), including two with recurrent septic shock and one with ventilator-induced severe pneumomediastinum and subcutaneous emphysema. No serious prespecified cell infusion-associated or treatment-related adverse events was identified in any patient. Serial flow-cytometric analyses of circulating inflammatory biomarkers (CD14+CD33+/CD11b+CD16+/CD16+MPO+/CD11b+MPO+/CD14dimCD33+) and mesenchymal stem cell markers (CD26+CD45–/CD29+CD45–/CD34+CD45–/CD44+CD45–/CD73+CD45–/CD90+CD45–/CD105+CD45–/CD26+CD45–) were notably progressively reduced (p for trend < 0.001), whereas the immune cell markers (Helper-T-cellCD3+CD4+/Cytotoxity-T-cellCD3+CD8+/Regulatory-T-cellCD4+CD25+FOXp3+) were notably increased (p for trend < 0.001) after cell infusion. Conclusions: The result of this phase I clinical trial showed that a single-dose IV infusion of human umbilical cord-derived mesenchymal stem cells was safe with favorable outcome in nine acute respiratory distress syndrome patients.