Topical Tranexamic Acid Group Research Articles

Clinical efficacy of tranexamic acid administrationviadifferent routes during total hip arthroplasty: study protocol for a prospective randomized controlled trial

Background: Intravenous injection or topical application of tranexamic acid during total hip arthroplasty has been shown to effectively reduce blood loss. There is no consensus on differences in clinical efficacy and safety between these two administration methods. To determine the optimal clinical efficacy of tranexamic acid during hip replacement, we will compare differences between these two administration methods during total hip arthroplasty. Methods/Design: The study protocol is a prospective, paired (1:1:1), double-blind, randomized controlled clinical trial. A total of 174 patients who will receive hip replacement at Ruijin Hospital, Shanghai Jiao Tong University, China will be randomly divided into three groups, with 58 patients per group. Before the end of surgery, in the placebo group, 60 mL of physiological saline will be used to soak the articular cavity for at least 3 minutes and then be sucked away; in the topical tranexamic acid group, 60 mL of physiological saline containing 3 g tranexamic acid will be used and then sucked away; in the intravenous tranexamic acid group, 100 mL of physiological saline containing 10 mg/kg tranexamic acid will be intravenously administered 15 minutes before surgery and then again 3 hours later. The primary outcome is total blood loss on postoperative day 3, which is calculated using Nadler's and Gross's formula. Secondary outcomes include blood transfusion rates, drainage output within 2 days postoperation, amount of human serum albumin used during hospitalization, postoperative blood coagulation indices, and incidences of deep venous thrombosis and other thromboembolic events during postoperative day 1-week 6. Discussion: This protocol is powered to provide reference information for the rational use of tranexamic acid by comparing clinical efficacy of the drug between intravenous and topical administration routes. Trial registration: ClinicalTrials.gov identifier: NCT02312440; registered on 28 November 2014. Ethical approval: This study protocol was approved by the Ethics Committee of Ruijin Hospital, Shanghai Jiao Tong University, China (permission No. (2014)-47-2) and will be performed in accordance with the Declaration of Helsinki.

Topical Tranexamic Acid Reduces Drainage Blood Loss in Primary Total Knee Arthroplasty: A Retrospective Study

Introduction: Total knee arthroplasty (TKA) surgery is associated with significant bleeding and commonly requires allogeneic blood transfusion. Although tranexamic acid (TXA) is reported to reduce post-operative bleeding, concerns on the safety of systemic TXA and of patients with higher risk of deep-vein thrombosis or pulmonary embolism have hindered its wider use. This retrospective study aimed to assess the safety and efficacy of topical TXA in patients undergoing primary TKA. Patients and methods: Between January 2008 and December 2011, a consecutive series of 271 patients who underwent TKAs in hospital single medical center were reviewed. The TXA group received topical tranexamic acid at the end of surgery while the control group did not. Drainage blood loss was measured and the need for blood transfusion was noted. Results: Drainage blood loss was significantly lower in the topical TXA group (304.9 ± 151.2 ml) than in the control group (520.2 ± 251.2 ml) (p ＜ 0.001). Blood transfusion rate was apparently lower in the TXA-treat group (14.3%) when compared to the group without TXA (44.4%) (p=0.013). There was no increase in deep vein thrombosis or wound complication. Conclusions: In this study, topical TXA can effectively reduce blood loss and transfusion rate, and is not associated with any increase in surgical complications.

Topical application of tranexamic acid versus systemic injection during coronary artery bypass graft surgery: a comparative study

Background Diffuse microvascular bleeding remains a common problem after myocardial revascularization with cardiopulmonary bypass. Objectives The efficacy of locally administered tranexamic acid (topical application) was compared with systemically administered tranexamic acid to reduce postoperative bleeding after cardiopulmonary bypass in elective nonredo coronary artery bypass grafting (CABG). Methods The study included 60 patients of both sexes, aged between 35 and 65 years, and scheduled for elective CABG; patients were randomly assigned to two groups: group I (the intravenous tranexamic acid group; 30 patients) and group II (the topical tranexamic acid group; 30 patients). For each patient in each group, postoperative blood loss, number of units of packed red blood cells (RBCs) and fresh frozen plasma (FFP) transfused, frequency of resternotomy, duration of hospital and ICU stay, and mortality were recorded. Results There were statistically significant differences between the two groups with regard to total postoperative blood loss and need for packed RBCs and FFP transfusion, being much greater in group I than in group II. There was no mortality in either group. Frequency of resternotomy was higher in group I than in group II, although the difference was statistically nonsignificant. The duration of hospital and ICU stay revealed no statistically significant differences between the two groups. Conclusion Intraoperative topical administration of tanexamic acid into the pericardial cavity before sternal closure during CABG surgery has reduced the incidence of postoperative blood loss and the need for postoperative packed RBCs and FFP transfusion.

Comparison of Topical and Intravenous Tranexamic Acid on Blood Loss and Transfusion Rates in Total Hip Arthroplasty

The objective of this study was to determine whether topical tranexamic acid (TXA) carried similar hemostatic effect compared with intravenous TXA in total hip arthroplasty (THA). Three hundred and three THA patients were enrolled and randomized into 3 groups: no TXA group, topical and intravenous TXA group. The results showed that the topical and intravenous TXA group had reduced but similar blood transfusion rates (5.88% v. s. 5.94%, P=0.816). No significant difference was detected in total blood loss between the two TXA groups [(963.4±421.3) ml vs. (958.5±422) ml P=0.733]. We conclude that topical use of TXA was equally effective and safe compared with intravenous TXA in reducing blood loss and transfusion rate following THA without substantial complications.

Topical Application of Tranexamic Acid in Primary Total Hip Arthroplasty: A Randomized Double-Blind Controlled Trial

So far, studies of topical tranexamic acid (TXA) in total hip arthroplasty (THA) were still lacking and controversial. We conducted this randomized double-blind controlled trial which included 101 patients to assess the effect of a high-dose 3g topical TXA in THA. The results showed that 3g topical TXA could significantly reduce transfusions from 22.4% to 5.7% (P<0.05) without increasing the risk of deep vein thrombosis (DVT), pulmonary embolism (PE) and other complications. In addition, topical TXA significantly reduced total blood loss, reduced drain blood loss, and the drops of HB and HCT in topical TXA group were lower than control group. We concluded that 3g topical TXA was effective and safe in reducing bleeding and transfusions in THA.

Topical versus intravenous tranexamic acid as a blood conservation intervention for reduction of post-operative bleeding in hemiarthroplasty.

Background:This study was performed to test the effectiveness of topical tranexamic acid (TXA) in reducing blood loss in pelvic hemiarthoplasty surgeries compared with intravenous TXA, regarding the incidence of thromboembolic complications (deep vein thrombosis [DVT], pulmonary embolism (PE) and cerebrovascular stroke [CVS]).Patients and Methods:After obtaining institutional ethical approval 60 patients divided into three groups. Group A: Received intravenous TXA Group B: Received topical TXA Group C: Control group (placebo saline). All patients were received general anesthesia and post-operative bleeding, immediate and 24 h post-operatively, hemoglobin concentration, hematocrit, platelets and coagulation profile (prothrombin time, activated partial thromboplastin time and international normalized ratio) baseline, immediate and 24 h post-operatively. Thromboelastography was recorded baseline, immediate and 24 h post-operatively. Incidence of DVT, PE and CVS was recorded.Results:There was statistical significant elevation hemoglobin concentration and hematocrit in both Groups A and B, significant increase in blood loss in Group C, significant increase in number of patients receiving blood in Group C, there was a significant decrease in “r” and “k” times and a significant increase in maximum amplitude and α-angle in Group A, statistically significant increase in the incidence of thromboembolic events in the form of DVT, PE and CVS in Group A.Conclusion:Topical TXA is effective in decreasing post-operative blood loss with possible side-effects of this route of administration.

Topical Application of Tranexamic Acid to Reduce Post-Operative Bleeding in Coronary Artery Bypass Surgery

Abstract 3432Patients who undergo on-pump coronary artery bypass graft surgery (CABG) are at an increased risk of bleeding due physiologic, mechanical and pharmacologic disruption of hemostasis. The use of topically applied antifibrinolytic agents has been explored as a blood-conservation adjunct to reduce post-operative bleeding in cardiac surgery. Analysis of pooled results in a meta-analysis published by Abrishami et al. in 2009 showed that a significant reduction in blood loss could be achieved utilizing topical tranexamic acid in the absence of concurrent intravenous antifibrinolytic agents. However, current blood conservation clinical practice guidelines recommend the use of intravenous lysine analogues to limit peri-operative blood loss.Presently, there is no published prospective data evaluating blood loss in CABG patients who have received intravenous tranexamic acid, plus topical tranexamic acid versus placebo. Our study was designed to determine whether combined intravenous and topical application of tranexamic acid would reduce post-CABG blood loss in low-risk bypass surgery candidates. A sample calculation based on pilot study data analysis concluded that a minimum total of 74 patients was required, allowing 80% power to detect a 200mL difference in total blood loss (Type I error = 0.05) between groups.In our prospective, double-blind, randomized controlled trial, patients enrolled were randomly assigned to receive an intra-operative cardiac bath of either normal saline or tranexamic acid solution prior to sternotomy closure. All participants received intravenous tranexamic acid prior to the initiation of circulatory bypass. Research subject participation ended upon transfer out of the intensive care unit. Primary outcomes included the total volume of chest tube blood loss and number of transfusions administered following CABG. Secondary outcomes included chest tube loss volumes at 6 hours and 12 hours.Between December 1, 2011 and April 30, 2012, a total of 41 patients who underwent randomization were included in final data analysis. Baseline characteristics of patients enrolled in both groups were similar. Post-CABG losses at chest tube removal were found to be significantly reduced in the patients who received topical tranexamic acid. Mean chest tube loss in the placebo group (n=18) was 789mL versus 632mL in the topical tranexamic acid group (n=23), with a difference of 157mL (Figure 1, p value of student t-test 0.0493). A significantly greater proportion of patients in the placebo group were found to bleed more than 700mL at chest tube removal, in comparison with the topical tranexamic acid group (72.2% versus 30.4%, p value of chi-squared test 0.0079). Chest tubes remained in situ for a mean duration of 20 hours and 19 hours, respectively. None of the patients received post-operative red cell transfusions. One patient, randomized to the topical tranexamic acid group, received a single dose each of platelets and cryoprecipitate post-operatively. The application of topical tranexamic acid did not significantly reduce blood loss at 6 hours and 12 hours, with a difference of 76mL (p=0.1876) and 106mL (p=0.0930) respectively.The application of topical tranexamic acid reduces post-operative blood loss in patients undergoing on-pump CABG who have received intravenous tranexamic acid. There was no difference in blood product use between groups. Further studies must be carried out to investigate long-term outcomes of this practice and its applicability in high-risk cardiac surgery patients. (ClinicalTrials.gov number, NCT01519245.) [Display omitted] Disclosures:Off Label Use: Intravenous and topical application of tranexamic acid in cardiac surgery.