An economic evaluation of tranexamic acid to prevent postpartum haemorrhage in women with vaginal delivery: the randomised controlled TRAAP trial.

OBJECTIVE: To estimate the cost-effectiveness of tranexamic acid (TXA) use to prevent postpartum haemorrhage. DESIGN: A trial-based economic evaluation. SETTING: Fifteen French university maternity hospitals. POPULATION: Women enrolled in the TRAAP randomised controlled trial comparing TXA versus placebo in women with vaginal delivery. TRAAP failed to show a reduction in postpartum haemorrhage of at least 500 ml in the intervention arm but evidenced significant lower rates of secondary outcomes related to blood loss. METHODS & MAIN OUTCOME MEASURES: We estimated direct medical costs from within-trial hospital resources collected prospectively from the study report form. All resources were costed at their value to the hospital. We estimated incremental cost per incremental haemorrhage averted. RESULTS: Among the 4079 women in the TRAAP trial, data necessary to calculate costs were available for 3836 (94.0%). The average total costs in the TXA and control groups were €2278 ± 388 and €2288 ± 409 per woman, respectively (P = 0.79). In women with postpartum haemorrhage of at least 500 ml (trial primary endpoint), costs were €2359 ± 354 and €2409 ± 525 (P = 0.14); for provider-assessed clinically significant postpartum haemorrhage and postpartum haemorrhage of at least 1000 ml, costs were respectively €2316 ± 347 versus €2381 ± 521 (P = 0.22) and €2321 ± 318 versus €2411 ± 590 (P = 0.35) in the tranexamic and placebo groups, respectively. The probabilistic sensitivity analysis showed that the use of TXA had a 65-73% probability of saving costs and improving outcome. CONCLUSIONS: Our findings support the use of TXA, as both bleeding events and cost may be reduced three out of four times. TWEETABLE ABSTRACT: Tranexamic acid at vaginal delivery reduces both costs and bleeding events 3 times out of 4.

Cost-Benefit Analysis of Using A Single Dose of Tranexamic Acid in Degenerative Lumbar Scoliosis Patients Undergoing Long-Segment Spinal Fusion Surgery: A Retrospective Study.

BACKGROUND Degenerative lumbar scoliosis (DLS) patients undergoing posterior long-segment spinal fusion surgery often require perioperative blood transfusions, and previous studies have reported that increased complications and additional costs accompany these transfusions. One method for decreasing transfusions is the administration of tranexamic acid (TXA). We sought to evaluate the costs and benefits of preoperative administration of 1 g of intravenous TXA, without maintenance, in DLS patients undergoing long-segment spinal fusion surgery. MATERIAL AND METHODS Patients who received TXA (TXA group) were compared with patients who did not receive TXA (NTXA group) with regard to blood loss, units of packed red blood cells (PRBC) transfused, hemostasis costs, and perioperative complications. The benefits and costs were estimated through analysis of the spending on NTXA and TXA patients, and were compared. The difference between the cost per patient in the 2 groups was designated as the net cost-benefit. Then, both groups were substratified into non-osteotomy and osteotomy subgroups for further analysis. RESULTS Of the 173 patients who met the inclusion criteria, 54 TXA patients had significantly reduced perioperative blood loss and total hemostasis costs compared with NTXA patients (n=119). In the group without osteotomy (n=72), TXA (n=13) reduced perioperative blood loss but did not significantly decrease PRBC units and hemostasis costs. However, in patients undergoing osteotomy (n=101), a remarkable net cost savings of ¥648.77 per patient was shown in the TXA group (n=41) (P<0.001). This was because patients undergoing osteotomy in the TXA group received fewer PRBC units (3.7 vs 5.7, P=0.001). CONCLUSIONS A single dose of TXA significantly decreased perioperative blood loss and total hemostasis costs for DLS patients undergoing osteotomy. Furthermore, TXA led to no additional net costs in patients without osteotomy.

Tranexamic acid in the routine treatment of postpartum hemorrhage in the United States: a cost-effectiveness analysis.

BACKGROUND: The World Maternal Antifibrinolytic trial demonstrated that tranexamic acid administered during postpartum hemorrhage reduces hemorrhage-related mortality and laparotomies. The World Health Organization has thus recommended early use of tranexamic acid in the treatment of postpartum hemorrhage. This recommendation has not been universally adopted in the United States, in part because of concerns about cost-effectiveness. OBJECTIVE: We aim to demonstrate the cost-effectiveness of routine tranexamic acid administration in the treatment of postpartum hemorrhage in the United States, where the rate of hemorrhage-related mortality is lower than that described in the World Maternal Antifibrinolytic trial. STUDY DESIGN: We constructed a decision tree comparing 3 strategies in women with a clinical diagnosis of postpartum hemorrhage: no tranexamic acid, tranexamic acid given at any time, and ideal use of tranexamic acid given within 3 hours of delivery. The study was performed from a health care institution perspective with a time horizon of delivery until 6 weeks postpartum. We included interventions that differed by arm in the World Maternal Antifibrinolytic trial (hemorrhage-related mortality, laparotomies, and brace or compression sutures) and incorporated probabilities and costs based on available data for a population of women with postpartum hemorrhage in the United States. In our base case, the rate of postpartum hemorrhage-related mortality was 0.0388%, and the cost of tranexamic acid was $37.80. We assumed that the relative risk reduction in death and laparotomy with tranexamic acid would be similar to the World Maternal Antifibrinolytic trial (19% and 36%, respectively). The primary outcome was incremental cost per hemorrhage-related death averted, and a main secondary outcome was incremental cost per laparotomy avoided under each strategy. Another planned secondary outcome was cost per quality-adjusted life-year. We anticipated that the risk reduction (benefit) because of tranexamic acid in the United States may be less than in the World Maternal Antifibrinolytic trial; thus, we performed 1-way and 2-way sensitivity analyses to explore the parameter uncertainty across a wide range of data-supported estimates. Probabilistic sensitivity analyses with Monte Carlo simulation were performed. RESULTS: Tranexamic acid strategies were dominant (more effective and cost saving) compared with no tranexamic acid for patients with postpartum hemorrhage in the United States. One-way analyses showed that tranexamic acid is cost saving as long as the relative risk reduction of death with tranexamic acid is greater than 4.7%; the model was not sensitive to any other variables. Threshold analyses outside the bounds defined in the model showed that tranexamic acid is cost saving as long as the relative risk reduction of laparotomy with tranexamic acid is greater than 7% or the cost of tranexamic acid is less than $194. A 2-way sensitivity analysis of the risk reduction of death because of tranexamic acid and the baseline risk of postpartum hemorrhage-related death confirmed that tranexamic acid is cost saving across a wide range of plausible estimates. Furthermore, probabilistic sensitivity analysis demonstrated that the tranexamic acid strategies are cost saving in >99.9% of 10,000 Monte Carlo simulations. Despite the initial cost of administration, the annual net cost savings expected from routine use of tranexamic acid for the treatment of postpartum hemorrhage in the United States is $11.3 million, and we estimate that 9 maternal deaths would be averted in 1 year with this strategy. Giving tranexamic acid within 3 hours would almost triple the cost savings and improve maternal outcomes much further. CONCLUSION: A policy of routine tranexamic acid early in the treatment of postpartum hemorrhage is likely to be cost saving in the United States. This conclusion holds true even when the relative risk reduction with tranexamic acid is significantly less than reported in the World Maternal Antifibrinolytic trial and when tranexamic acid is significantly more expensive than currently reported.

The Effect of Tranexamic Acid on Functional Outcomes: An Exploratory Analysis of the CRASH-2 Randomized Controlled Trial.

STUDY OBJECTIVE: Tranexamic acid improves survival in severely injured adults. However, its effectiveness on overall functional outcome is unknown. We hypothesized that tranexamic acid improves overall functional outcome compared with placebo in severely injured adults and conduct an exploratory analysis of the Clinical Randomization of an Antifibrinolytic in Significant Haemorrhage (CRASH-2) data to investigate this hypothesis. METHODS: We included injured adults from the CRASH-2 trial who were randomized 3 hours or less from injury. The primary outcome measure was functional status at hospital discharge or on day 28 if the subject was still in the hospital. Functional status was measured with the modified Oxford Handicap Scale, a 6-category ordinal functional outcome scale. We conducted 3 separate analyses using 3 different outcome measures to evaluate the effectiveness of tranexamic acid versus placebo on functional outcomes, including the mean utility-weighted modified Oxford Handicap Scale score (overall functional outcome), the area under the curve (based on functional outcome and rate of recovery), and a sliding dichotomy analysis (favorable versus unfavorable functional outcome) stratified by baseline mortality risk (stratified analysis). RESULTS: There were 13,432 patients (6,679 randomized to placebo and 6,753 to tranexamic acid) included in the study cohort. The mean utility-weighted modified Oxford Handicap Scale score was 0.66 (SD 0.33) for patients randomized to tranexamic acid compared with a mean of 0.64 (SD 0.34) for those randomized to placebo (mean difference 0.02; 95% confidence interval [CI] 0.01 to 0.03). The area under the curve analysis demonstrated that patients randomized to tranexamic acid had a higher 28-day mean utility-weighted modified Oxford Handicap Scale score compared with those randomized to placebo (mean score 0.55 [SD 0.30] versus 0.53 [SD 0.31]; mean difference 0.02 [95% CI 0.01 to 0.03]). The sliding dichotomy analysis demonstrated heterogeneity of treatment effects across risk groups. The overall proportion of patients with favorable functional outcomes was higher in the tranexamic acid group (5,360/6,753 [79.4%]; 95% CI 78.4% to 80.3%) compared with the placebo group (5,174/6,679 [77.5%]; 95% CI 76.5% to 78.5%; difference 1.9% [95% CI 0.5% to 3.3%]; number needed to treat=52). When each risk group was tested separately, only the lowest-risk group (<6% baseline mortality risk) demonstrated a statistically significant effect of tranexamic acid toward favorable functional outcomes (tranexamic acid versus placebo adjusted odds ratio 0.78; 95% CI 0.67 to 0.90). There were no differences between tranexamic acid and placebo in the other risk groups. CONCLUSION: Across 3 exploratory analyses, severely injured adult patients randomized within 3 hours from injury demonstrated better functional outcomes with tranexamic acid compared with placebo. When heterogeneity of treatment effects across risk groups was evaluated, only the lowest-risk group demonstrated a significant effect of tranexamic acid toward favorable outcomes. Given the overall safety and cost-effectiveness of tranexamic acid use in injured adults, our results further support the use of tranexamic acid for this population. Future trauma trials that evaluate tranexamic acid use should also consider functional status as an important outcome.

Clinical Impact of Routine Complete Blood Counts Following Total Knee Arthroplasty.

BACKGROUND: Routine laboratory studies are generally obtained following total knee arthroplasty (TKA), and often continued daily until discharge. This study aims to investigate the utility and cost-effectiveness of complete blood count (CBC) tests following TKA. METHODS: Retrospective review identified 484 patients who underwent primary TKA under a tourniquet at a single institution. Preoperative and postoperative CBC values were collected along with demographic data, use of tranexamic acid (TXA), and transfusion rates. Logistic regression models were calculated for all variables. RESULTS: Twenty-five patients required transfusion following TKA (5.2%). Patients requiring transfusion had significantly lower preoperative hemoglobin compared to patients who did not require transfusion (11.47 vs 13.58 g/dL, P = .005). Risk of transfusion was 5.2 times higher in patients with preoperative anemia (95% confidence interval 2.90-9.35, P < .001). Without TXA, patients were 2.75 times more likely to receive transfusion (95% confidence interval 1.43-5.30, P < .001). An average of 2.9 CBC tests were collected per patient who did not receive medical intervention, costing a total of $144,773.80 in associated hospital charges ($316.10 per patient). CONCLUSION: Ensuring quality, cost-effective patient care following total joint arthroplasty is essential in the era of bundled payments. Routine postoperative CBCs do not add value for patients with normal preoperative hemoglobin who receive TXA during TKA performed under tourniquet. Patients who are anemic preoperatively or do not receive TXA should obtain a postoperative CBC test. Daily CBCs are unnecessary if the first postoperative CBC does not prompt intervention.

Efficacy and safety of oral compared with intravenous tranexamic acid in reducing blood loss after primary total knee and hip arthroplasty: a meta-analysis.

BACKGROUND: Tranexamic acid (TXA) is an anti-fibrinolytic agent successfully preventing blood loss when using intravenously (IV) in total hip arthroplasty (THA) and total knee arthroplasty (TKA). An oral administration, which is available on blood sparing, has been reported exhibit profound cost-saving benefits. The aim of this meta-analysis is to investigate whether the administration of oral and intravenous tranexamic acid postoperatively has equivalent blood-sparing properties in these patients. METHODS: The online electronic databases were searched for eligible literatures updated on September 2018. Studies assessing the effect between oral TXA and intravenous TXA (IV-TXA) in those undergoing TKA or THA were included. All the data were pooled with the corresponding 95% confidence interval (CI) using RevMan software. Based on the heterogeneity, we performed a systematic analysis to explore the overall results across the included studies. RESULTS: Nine studies met our inclusion criteria. No significant differences were identified with regard to the Hb drop (SMD = - 0.03,95%CI = - 0.18-0.12, P = 0.67), total Hb loss (SMD = 0.10,95%CI = - 0.06-0.26, P = 0.24), total blood loss (SMD = - 0.00,95%CI = - 0.20-0.20, P = 1.00), transfusion rate (OR = 0.77,95%CI = 0.54-1.10, P = 0.14), DVT rate (OR = 0.58,95%CI = 0.19-1.75, P = 0.33), and length of hospital stay (SMD = - 0.05,95%CI = - 0.28-0.17, P = 0.63) between the oral groups and intravenous group. CONCLUSION: The blood-sparing efficacy of oral TXA is similar to that of the intravenous forms in the setting of THA and TKA. Considering the cost-benefit superiority and ease of administration of oral TXA, further studies and clinical trials are required to further identify the optimal administration for THA and TKA.

Pharmacologic Hemostatic Agents in Total Joint Arthroplasty-A Cost-Effectiveness Analysis.

BACKGROUND: Total knee and hip arthroplasties can be associated with substantial blood loss, affecting morbidity and even mortality. Two pharmacological antifibrinolytics, ε-aminocaproic acid (EACA) and tranexamic acid (TXA) have been used to minimize perioperative blood loss, but both have associated morbidity. Given the added cost of these medications and the risks associated with then, a cost-effectiveness analysis was undertaken to ascertain the best strategy. METHODS: A cost-effectiveness model was constructed using the payoffs of cost (in United States dollars) and effectiveness (quality-adjusted life expectancy, in days). The medical literature was used to ascertain various complications, their probabilities, utility values, and direct medical costs associated with various health states. A time horizon of 10 years and a willingness to pay threshold of $100,000 was used. RESULTS: The total cost and effectiveness (quality-adjusted life expectancy, in days) was $459.77, $951.22, and $1174.87 and 3411.19, 3248.02, and 3342.69 for TXA, no pharmacologic hemostatic agent, and EACA, respectively. Because TXA is less expensive and more effective than the competing alternatives, it was the favored strategy. One-way sensitivity analyses for probability of transfusion and myocardial infarction for all 3 strategies revealed that TXA remains the dominant strategy across all clinically plausible values. CONCLUSION: TXA, when compared with no pharmacologic hemostatic agent and with EACA, is the most cost-effective strategy to minimize intraoperative blood loss in hip and knee total joint arthroplasties. These findings are robust to sensitivity analyses using clinically plausible probabilities.

Craniosynostosis Surgery and the Impact of Tranexamic Acid Dosing.

Consensus does not exist regarding the best dosage regimen for using tranexamic acid (TXA) for patients undergoing open calvarial vault remodeling in craniosynostosis surgery. The purpose of this study was to evaluate 2 dosing protocols, as well as the cost of using TXA. Previously, the institutional protocol was to give patients undergoing open calvarial vault remodeling a loading infusion of TXA (10 mg/kg) at the start of their procedure, after which intravenous TXA (5 mg/kg/h) was given throughout surgery and for 24 hours postoperatively. In July 2015, the protocol changed to a reduced postoperative infusion time of 4 hours. A retrospective review was conducted of records of 30 patients who had surgery before the protocol change (24-hour group) and 23 patients whose surgery occurred after the protocol change (4-hour group). The following data were collected: blood volume transfused, hemoglobin levels, estimated blood loss, and intensive care days; and costs of TXA and blood transfusion. Results showed a 4-hour infusion was as effective as a 24-hour infusion for reducing blood loss in patients undergoing craniosynostosis. Transfusion requirements, hemoglobin and hematocrit levels, and estimated blood loss were not significantly different for the groups. The cost of TXA and transfusion in the 4-hour group was significantly less (P < 0.001) than in the 24-hour group. No significant difference in cost existed for patients who received blood transfusion alone versus patients who received the 4-hour TXA infusion.

Topical Tranexamic Acid is Equivalent to Targeted Preoperative Autologous Blood Donation in Total Hip Arthroplasty.

BACKGROUND: Topical tranexamic acid (TXA) was introduced to replace the previous targeted preoperative autologous blood donation (PABD) program. This study aims to analyze the efficacy of topical TXA compared with targeted PABD in anemic patients undergoing primary total hip arthroplasty (THA). METHODS: Two thousand two hundred fifty-one patients underwent primary THA between 2009 and 2013 using targeted autologous blood donation for 280 anemic patients (12%; Hb <12.5 g/dL). One thousand nine hundred seventy-one nonanemic patients (88%; ≥12.5 Hb/dL) received no blood management intervention. Starting in 2014, 505 consecutive patients were operated using 3 grams of topical TXA and abandoning PABD. Ninety-one patients (18%) were anemic and 414 (82%) nonanemic. RESULTS: The utilization of topical TXA in anemic patients resulted in higher hemoglobin levels on the first postoperative day (P = .014), but not on the second postoperative day (P = .198) compared with PABD. There was no difference in allogeneic transfusion rates between both groups: 12% vs 13% (P = .848). In the nonanemic group, TXA significantly increased hemoglobin levels on the first postoperative day (P = .001) as well as on the second postoperative day (P < .001), and resulted in a reduction in allogeneic transfusion rates from 8% to 1%. CONCLUSION: The present study suggests that topical TXA is equivalent to PABD in anemic patients and reduces transfusion rates and increases Hb-levels in nonanemic patients.

Oral Tranexamic Acid Reduces Transfusions in Total Knee Arthroplasty.

BACKGROUND: Tranexamic acid (TXA) reduces intraoperative blood loss and transfusions in patients undergoing total knee arthroplasty. Although numerous studies demonstrate the efficacy of intravenous and topical TXA in these patients, few demonstrate the effectiveness and appropriate dosing recommendations of oral formulations. METHODS: A retrospective cohort study was performed to evaluate differences in transfusion requirements in patients undergoing primary unilateral total knee arthroplasty with either no TXA (n = 866), a single-dose of oral TXA (n = 157), or both preoperative and postoperative oral TXA (n = 1049). Secondary outcomes included postoperative hemoglobin drop, total units transfused, length of stay, drain output, and cell salvage volume. RESULTS: Transfusion rates decreased from 15.4% in the no-oral tranexamic acid (OTA) group to 9.6% in the single-dose OTA group (P < .001) and 7% in the 2-dose group (P < .001), with no difference in transfusion rates between the single- and 2-dose groups (P = .390). In addition, postoperative hemoglobin drop was reduced from 4.2 g/dL in the no-OTA group to 3.5 g/dL in the single-dose group (P < .01) and to 3.4 g/dL in the 2-dose group (P < .01), without a difference between the single- and 2-dose groups (P = .233). CONCLUSION: OTA reduces transfusions, with greater ease of administration and improved cost-effectiveness relative to other forms of delivery.

Process Improvement Project Using Tranexamic Acid Is Cost-Effective in Reducing Blood Loss and Transfusions After Total Hip and Total Knee Arthroplasty.

BACKGROUND: Tranexamic acid (TXA) has been associated with decreased blood loss and transfusion after total hip arthroplasty (THA) and total knee arthroplasty (TKA). The purpose of this study was to examine both transfusion utilization and the economic impact of a Process Improvement Project implementing TXA for THA and TKA. METHODS: After standardization of TXA administration in THA and TKA patients, retrospective data were compared from 12 consecutive months before (group A, n = 336 procedures) and after (group B, n = 436 procedures) project initiation. RESULTS: TXA administration increased with project implementation (group A = 3.57%, group B = 86.01%) and was associated with reductions in perioperative hemoglobin decrement (20.2%), patients transfused (45%), and number of units transfused per patient (61.9%). Cost savings were notable per patient ($128) and annually program wide ($55,884) with the primary THA subgroup contributing the most to the savings. No increase in adverse effects was observed. CONCLUSION: Standardized administration of TXA is an effective and economically favorable blood-reduction strategy for patients undergoing elective THA or TKA. Although reduction in transfusions with TXA may be greater after TKA, the economic and clinical impact of transfusion reduction is more substantial in THA patients.

[Local Application of Tranexamic Acid in Total Hip Arthroplasty Decreases Blood Loss and Consumption of Blood Transfusion]. / Lokální aplikace kyseliny tranexamové u TEP kycle snizuje krevní ztráty a spotrebu krevních transfuzí.

PURPOSE OF THE STUDY The primary aim of our study was to identify the effects of local application of tranexamic acid (TXA, Exacyl) on the amount of postoperative blood loss and blood transfusion requirement in primary total hip arthroplasty. We also recorded the levels of postoperative haemoglobin and its drop in early period after surgery. In each patient, we monitored in detail the incidence of early complications (haematoma, wound exudate). Lastly, the economic aspect of TXA administration was also taken into account. MATERIAL AND METHODS The prospective study included a total of 312 patients (122 men and 190 women) undergoing primary total hip arthroplasty (THA) at our department between January 2012 and November 2015. The patients enrolled in the study were divided into the intervention group with local (intra-articular) application of TXA and the control group without using TXA. Each group had 156 patients. The mean age of patients in the group with TXA was 65.6 years and the most frequent indication for THA surgery was primary osteoarthritis (59.0 %). The groups did not show any differences in basic characteristics, which was statistically verified. In each patient the volume of postoperative drainage, total blood loss, including the hidden loss, was recorded. In postoperative period, we monitored the haemoglobin levels and haematocrit. On discharge of each patient from the hospital, the size and site of a haematoma, wound exudate if still present even after postoperative day 4 and early surgical revision were evaluated. RESULTS In the group with TXA the blood losses from drains were significantly lower compared to the control group (493.4 ± 357.1 ml vs. 777.3 ± 382.5 ml; p < 0.0001). The median value for total blood loss (i.e. drainage volume and hidden loss) in the group with TXA was by 29.5 % lower than the median in the group without TXA (689.2 vs. 977.1 ml). The mean total blood loss (intraoperative + postoperative) was 783.8 ± 478.6 ml (mean ± standard deviation) in the patients with TXA and 1079.7 ± 487.1 ml in the second group without TXA. The difference in the total blood loss volume was significant (p < 0.0001). In the group with TXA the consumption of blood transfusion was significantly lower by 50 % (20 vs. 40 units), (p = 0.0004). The patients with TXA also reported a significantly lower consumption of allogeneic blood (p = 0.004), a higher level of postoperative haemoglobin (p < 0.0001) and a lower mean drop of haemoglobin (p < 0.0001). We did not observe any significant differences in the incidence of haematomas (p = 0.644). No higher volume of wound drainage and joint swelling after postoperative day 4 in patients with TXA was found (p = 0.565; p = 0.242). The TXA group did not show a higher rate of surgical revision (p = 1.000). The total economic costs of blood transfusion requirements were significantly lower in the TXA group than in the control group (p = 0.004), including consumption of autologous transfusions and blood salvage (p < 0.0001). DISCUSSION The main effect of the local application of TXA is to reduce bleeding which should result in lower postoperative blood loss and consumption of allogenic blood transfusion. The advantage of the local application of TXA is its easy application and maximum concentration of TXA at the surgical site. In addition, a potential harm associated with a systemic administration of a higher TXA dose is reduced because of only minimal TXA resorption into the circulation. According to a number of recent studies, the local application of TXA achieves comparable results to its intravenous application. The economic benefit of TXA intervention is also worth considering. CONCLUSIONS The local application of TXA is an effective and, simultaneously, safe method to reduce perioperative blood loss and consumption of blood transfusions and also to decrease the costs of hospital stay in the patients after THA. Another advantage of the local application is the need to administer one dose only, whereas at least two doses need to be administered intravenously in order to achieve the same effect. No significant complications were observed in the patients with TXA. According to the recent literature, it is therefore appropriate to include the local application of TXA among the recommended procedures for THA, as is the case in total knee arthroplasty. Key words: tranexamic acid, local application, blood loss, hidden blood loss, THA, total hip arthroplasty, complications.

Cost Analysis of Tranexamic Acid in Anemic Total Joint Arthroplasty Patients.

BACKGROUND: Preoperative anemia is present in 20% of total joint arthroplasty patients. Current preoperative treatment options, including iron supplementation (FE) and erythropoietin (EPO), are expensive. Tranexamic acid (TXA) has been adopted as an intraoperative adjunct to decrease blood loss. Our hypothesis is that TXA is a cost-effective treatment compared to FE and EPO in anemic patients. METHODS: In this study, a cost analysis was performed, comparing the material costs of TXA and packed red blood cells (PRBCs) to the theoretical administration and material costs of FE and EPO per standard preoperative anemia protocol. RESULTS: A total of 243 patients were included in the study. Of this group, 18.5% (45/243) had preoperative anemia. The rate of transfusion was 6.7% (3/45), and 5 units of PRBCs was transfused. The combined cost of TXA and PRBCs was $5317.08. Even assuming a best-case scenario with FE or EPO treatment without a postoperative PRBC requirement, the cost of treatment would range from 2 to 17 times more than treatment with TXA. An additional 50 units of PRBC (1.1 units per patient) would need to be transfused for the cost of TXA treatment to be equivalent to FE or EPO treatment. CONCLUSION: Tranexamic acid is significantly less expensive than FE or EPO as a treatment option for total joint arthroplasty patients presenting with preoperative anemia. It is a cost-effective adjunct for limiting transfusion rates in this patient population. We recommend that new preoperative anemia levels that necessitate preoperative intervention be established.

[Intra-Articular Application of Tranexamic Acid Significantly Reduces Blood Loss and Transfusion Requirement in Primary Total Knee Arthroplasty]. / Lokální aplikace kyseliny tranexamové významne snizuje mnozství krevních ztrát a spotrebu krevních transfuzí po primární TEP kolena.

PURPOSE OF THE STUDY The aim of this prospective study was to investigate the effect of topical application of tranexamic acid (TXA, Exacyl) on the amount of post-operative blood loss, and blood transfusion requirement in patients undergoing primary total knee arthroplasty (TKA). Attention was paid to early complications potentially associated with TXA administration, such as haematoma, wound exudate, or knee swelling. In addition, the economic benefit of TXA treatment was also taken into account. MATERIAL AND METHODS The study included 238 patients (85 men and 153 women) who underwent primary total knee arthroplasty (TKA) at our department between January 2013 and November 2015. A group of 119 patients (41 men and 78 women) received intraarticular TXA injections according to the treatment protocol (TXA group). A control group matched in basic characteristics to the TXA group also consisted of 119 patients. The average age in the TXA group was 69.8 years, and the most frequent indication for TKA surgery was primary knee osteoarthritis (81.5%). In each patient, post-operative volume of blood lost from drains and total blood loss including hidden blood loss were recorded, as well as post-operative haemoglobin and haematocrit levels. On discharge of each patient from hospital, the size and site of a haematoma; wound exudate, if present after post-operative day 4; joint swelling; range of motion and early revision surgery, if performed, were evaluated. Requirements of analgesic drugs after surgery were also recorded. RESULTS In the TXA group, blood losses from drains were significantly lower than in the control group (456.7 ± 270.8 vs 640.5 ±448.2; p = 0.004). The median value for blood losses from drains was lower by 22% and the average value for total blood loss, including hidden losses, was also lower than in the control group (762.4 ± 345.2 ml vs 995.5 ± 457.3 ml). The difference in the total amount of blood loss between the two groups was significant (p = 0.0001), including hidden blood loss (p = 0.030). The TXA patients had significantly fewer requirements for allogeneic blood transfusion (p < 0.0004), higher post-operative haemoglobin levels (p = 0.014), lower incidence of haematomas (p = 0.0003), and a significantly higher flexion degree on discharge from hospital (p < 0.0001). No higher volume of wound drainage was found (p = 1.000). Only one patient of the TXA group underwent revision surgery due to wound healing disturbance. The total costs of blood transfusion requirements were significantly lower in the TXA group than in the control group (p = 0.0004). DISCUSSION Topical administration allows the antifibrinolytic effect of TXA to act directly at a bleeding site. Its advantages involve easy application, maximum TXA concentration at the site of application, no danger associated with administration of a higher TXA dose and minimal TXA resorption into the circulation. On the other hand, there are no exact instructions for an effective and safe topical application of TXA and some authors are concerned that a coagulum arising after TXA application might affect soft tissue behaviour (healing, swelling, rehabilitation) or result in infection. CONCLUSIONS The study showed the efficacy and safety of topical TXA administration resulting in lower peri-operative bleeding, fewer blood transfusion requirements and higher haemoglobin levels after TKA. The patients treated with TXA had less knee swelling, lower incidence of haematomas and used fewer analgesic drugs in the early post-operative period. The economic benefit is also worth considering. In agreement with the recent literature, it is suggested to add topical TXA application to the recommended procedures for TKA surgery. Key words: tranexamic acid, Exacyl, topical application, intra-articular application, blood loss, hidden blood loss, total knee arthroplasty, complications.

Transfusion cost savings with tranexamic acid in primary total knee arthroplasty from 2009 to 2012.

Tranexamic acid (TXA) has proven to be very advantageous to the total knee arthroplasty (TKA) population. With TXA, the need for allogeneic blood transfusion is reduced and thus hospital costs are reduced. In our hospital system, before TXA was used, facility cost was an estimated $84.90/TKA for blood transfusion and required 0.13 man-hours/TKA (transfusion rate 6.5%); after incorporating intravenous TXA, cost was $82.59/TKA for blood transfusion and TXA medication and 0.007 man-hours/TKA (transfusion rate 0.3%). There were no transfusions when TXA was applied topically, and the facility cost was $39.14/TKA and no employee hours consumed. Topical TXA has the potential to significantly reduce blood transfusions and decrease hospital man-hours/TKA as well as achieve larger cost saving.

Cost benefit analysis of topical tranexamic acid in primary total hip and knee arthroplasty.

The purpose of this study was to provide a cost-benefit analysis of topical tranexamic acid (TXA) in primary total hip and knee arthroplasty patients. A retrospective cohort of 591 consecutive patients, 311 experimental and 280 control, revealed a transfusion rate reduction from 17.5% to 5.5%, increased postoperative hemoglobin, and decreased delta hemoglobin without an increase in adverse events (all P < 0.001). This led to saving $83.73 per patient based on transfusion costs alone after accounting for the cost of TXA. Hospital disposition to home compared to subacute nursing facility was also significantly increased by 9.3% (P < 0.02). We conclude that topical TXA reduces transfusion rate, increases home disposition, and reduces cost in primary hip and knee arthroplasty.

The cost-utility of intraoperative tranexamic acid in adult spinal deformity patients undergoing long posterior spinal fusion.

PURPOSE: This study aims to evaluate the cost-utility of intraoperative tranexamic acid (TXA) in adult spinal deformity (ASD) patients undergoing long posterior (≥ 5 vertebral levels) spinal fusion. METHODS: A decision-analysis model was built for a hypothetical 60-year-old adult patient with spinal deformity undergoing long posterior spinal fusion. A comprehensive review of the literature was performed to obtain event probabilities, costs and health utilities at each node. Health utilities were utilized to calculate Quality-Adjusted Life Years (QALYs). A base-case analysis was carried out to obtain the incremental cost and effectiveness of intraoperative TXA. Probabilistic sensitivity analysis was performed to evaluate uncertainty in our model and obtain mean incremental costs, effectiveness, and net monetary benefits. One-way sensitivity analyses were also performed to identify the variables with the most impact on our model. RESULTS: Use of intraoperative TXA was the favored strategy in 88% of the iterations. The mean incremental utility ratio for using intraoperative TXA demonstrated higher benefit and lower cost while being lower than the willingness-to-pay threshold set at $50,000 per quality adjusted life years. Use of intraoperative TXA was associated with a mean incremental net monetary benefit (INMB) of $3743 (95% CI 3492-3995). One-way sensitivity analysis reported cost of blood transfusions due to post-operative anemia to be a major driver of cost-utility analysis. CONCLUSION: Use of intraoperative TXAs is a cost-effective strategy to reduce overall perioperative costs related to post-operative blood transfusions. Administration of intraoperative TXA should be considered for long fusions in ASD population when not explicitly contra-indicated due to patient factors.

Economic impact of tranexamic acid in healthy patients undergoing primary total hip and knee arthroplasty.

Tranexamic acid (TA) has been shown to reduce perioperative blood loss and blood transfusion. While concern remains about the cost of antifibrinolytic medication, we hypothesized that routine use of tranexamic acid would result in lower direct hospital total cost by decreasing costs associated with blood transfusion, laboratory testing, and room & board. Patients with an American Society of Anesthesiologists (ASA) class II or less undergoing primary total hip or knee arthroplasty at a single institution during 2007-2008 were retrospectively reviewed. The estimated mean direct hospital total cost, operating room, blood/lab, room & board, and pharmacy costs were compared between patients who did and did not receive TA. The study population included 1018 patients, and 580 patients received TA. The mean direct total cost of hospitalization with and without TA was $15,099 and $15,978 (P<.0002) respectively, a difference of $879. The only increased cost associated with TA was the pharmacy cost which was $921 versus $781 (P<.0001). The routine use of tranexamic acid TA was associated with lower mean direct hospital total costs after primary total hip and knee arthroplasty as the increase in pharmacy costs was more than offset by cost savings in other categories.

[Pharmacological reduction of bleeding during hip endoprosthetic replacement]. / Gyógyszeres vérzéscsillapítás csípoízületi endoprotézis-beültetések során.

INTRODUCTION: Endoprosthetic replacement of the large joints is accompanied by major bleeding. During the last few years several authors reported the perioperative administration of tranexamic acid and its beneficial effect on reducing the blood loss. OBJECTIVES: In the present study, the author studied the effect of intravenously administered tranexamic acid in patients undergoing primary total hip arthroplasty in order to examine whether this treatment could reduce postoperative blood loss, the amount of transfused packed red cells, and the cost of the blood saving and/or transfusion. METHODS: The author compared retrospectively the data of 104 patients undergoing primary total hip arthroplasty between April, 2010 and December, 2011. 54 patients were administered tranexamic acid (Group 1) and 50 patients were treated without tranexamic acid (Group 2). The amount of postoperative bleeding, haemoglobin, hematocrit, red blood cell count, and the number of units of the transfused packed red cells were recorded. Cost effectiveness of treatment with tranexamic acid was calculated. RESULTS: Postoperative blood loss in Group 1 was 732 ml (210-1280 ml), and in Group 2 1092 ml (420-2640 ml). Ten of the 54 patients in Group 1 had to be transfused, and the all-over need was 20 units of packed red cells. 49 of the 50 patients in Group 2 received 98 units of allogenic blood. Thromboembolic complication was not observed in connection with the use of tranexamic acid. The reduction of blood loss with the application of tranexamic acid and the transfused packed red cells cost in average 5,180 HUF per patient in Group 1 and 15,850 HUF in Group 2. CONCLUSIONS: Intravenous administration of tranexamic acid reduces effectively the transfusion rate and the blood loss in the postoperative period in patients undergoing primary total hip arthroplasty. More than 1.5 million HUF and 240 units of packed red cells could be yearly saved with the introduction of this simple, safe and cheap method of drug administered blood conservation.

ε-Aminocaproic acid and clinical value in cardiac anesthesia.

OBJECTIVE: The primary aim was to compare the "clinical value" of tranexamic acid (TXA) with ε-aminocaproic acid (EACA) when used for blood conservation during high-risk cardiac surgery. DESIGN: Data previously reported by the Blood Conservation Using Antifibrinolytics in a Randomized Trial (BART) study investigators were reanalyzed independently after appropriate statistical adjustment. The authors compared TXA with EACA for important primary and secondary outcomes and applied the "clinical value" equation to this comparison. SETTING: BART, the largest blinded multicenter study on this topic to date, compared all 3 commonly used antifibrinolytics head-to-head in a randomized dose-equivalent fashion during high-risk cardiac surgery. Comparisons of TXA with EACA with application of the clinical value equation was not performed specifically by the BART investigators. PARTICIPANTS: One thousand five hundred fifty patients enrolled in 2 of the 3 arms of the BART study were included in the analysis (TXA, n= 770 and EACA, n = 780, with data reported by the investigators in the New England Journal of Medicine). MAIN RESULTS: The major finding was that there were no significant differences in overall safety and clinically important efficacy between TXA and EACA. CONCLUSIONS: Considering the substantial difference in costs and with the increasing volume of high-risk cardiac surgery, EACA has increased "clinical value" when compared with TXA. EACA should be the antifibrinolytic medication of choice for high-risk cardiac surgery.