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[Efficacy and safety of multiple-dose intravenous tranexamic acid for reducing blood loss in complex tibial plateau fractures: A prospective randomized controlled trial]
Bao, W., Zhou, J., Wang, Y., Wang, J., Chu, M.
Zhongguo xiu fu chong jian wai ke za zhi = Zhongguo xiufu chongjian waike zazhi = Chinese journal of reparative and reconstructive surgery. 2023;37(9):1055-1061
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Editor's Choice
Abstract
OBJECTIVE To investigate the efficacy and safety of multiple-dose intravenous tranexamic acid (TXA) for reducing blood loss in complex tibial plateau fractures with open reduction internal fixation by a prospective randomized controlled trial. METHODS A study was conducted on patients with Schatzker type Ⅳ-Ⅵ tibial plateau fractures admitted between August 2020 and December 2022. Among them, 88 patients met the selection criteria and were included in the study. They were randomly allocated into 3 groups, the control group (28 cases), single-dose TXA group (31 cases), and multiple-dose TXA group (29 cases), using a random number table method. There was no significant difference ( P>0.05) in terms of age, gender, body mass index, the Schatzker type and side of fracture, laboratory examinations [hemoglobin (Hb), activated partial thromboplastin time (APTT), prothrombin time (PT), fibrinogen (Fib), international normalized ratio (INR), D-dimer, and interleukin 6 (IL-6)], and preoperative blood volume. The control group received intravenous infusion of 100 mL saline at 15 minutes before operation and 3, 6, and 24 hours after the first administration. The single-dose TXA group received intravenous infusion of 1 g TXA (dissolved in 100 mL saline) at 15 minutes before operation, followed by an equal amount of saline at each time point after the first administration. The multiple-dose TXA group received intravenous infusion of 1 g TXA (dissolved in 100 mL saline) at each time point. The relevant indicators were recorded and compared between groups to evaluate the effectiveness and safety of TXA, including hospital stays, operation time, occurrence of infection; the occurrence of lower extremity deep vein thrombosis, intermuscular vein thrombosis, and pulmonary embolism at 1 week after operation; the lowest postoperative Hb value and Hb reduction rate, the difference (change value) between pre- and post-operative APTT, PT, Fib, and INR; D-dimer and IL-6 at 24 and 72 hours after operation; total blood loss, intraoperative blood loss, hidden blood loss, drainage flow during 48 hours after operation, and postoperative blood transfusion. RESULTS ① TXA efficacy evaluation: the lowest Hb value in the control group was significantly lower than that in the other two groups ( P<0.05), and there was no significant difference between the single- and multiple-dose TXA groups ( P>0.05). The Hb reduction rate, total blood loss, intraoperative blood loss, drainage flow during 48 hours after operation, and hidden blood loss showed a gradual decrease trend in the control group, single-dose TXA group, and multiple-dose TXA group. And differences were significant ( P<0.05) in the Hb reduction rate and drainage flow during 48 hours after operation between groups, and the total blood loss and hidden blood loss between control group and other two groups. ② TXA safety evaluation: no lower extremity deep vein thrombosis or pulmonary embolism occurred in the three groups after operation, but 3, 4, and 2 cases of intermuscular vein thrombosis occurred in the control group, single-dose TXA group, and multiple-dose TXA group, respectively, and the differences in the incidences between groups were not significant ( P>0.05). There was no significant difference in the operation time between groups ( P>0.05). But the length of hospital stay was significantly longer in the control group than in the other groups ( P<0.05); there was no significant difference between the single- and multiple-dose TXA groups ( P>0.05). ③ Effect of TXA on blood coagulation and inflammatory response: the incisions of the 3 groups healed by first intention, and no infections occurred. The differences in the changes of APTT, PT, Fib, and INR between groups were not significant ( P>0.05). The D-dimer and IL-6 in the three groups showed a trend of first increasing and then decreasing over time, and there was a significant difference between different time points in the three groups ( P<0.05). At 24 and 72 hours after operation, there was no significant difference in D-dimer between groups ( P>0.05), while there was a significant difference in IL-6 between groups ( P<0.05). CONCLUSION Multiple intravenous applications of TXA can reduce perioperative blood loss and shorten hospital stays in patients undergoing open reduction and internal fixation of complex tibial plateau fractures, provide additional fibrinolysis control and ameliorate postoperative inflammatory response.
PICO Summary
Population
Patients with Schatzker type IV – VI tibial plateau fractures (n= 88).
Intervention
Single dose of tranexamic acid (TXA) intravenous infusion, (n= 31).
Comparison
Multiple dose of intravenous TXA (n= 29); normal saline (control group), (n= 28).
Outcome
TXA efficacy evaluation: The lowest haemoglobin (Hb) value in the control group was significantly lower than that in the other two groups, and there was no significant difference between the single and multiple dose TXA groups. The Hb reduction rate, total blood loss, intraoperative blood loss, drainage flow during 48 hours after operation, and hidden blood loss showed a gradual decrease trend in the control group, single-dose TXA group, and multiple-dose TXA group. And differences were significant in the Hb reduction rate and drainage flow during 48 hours after operation between groups, and the total blood loss and hidden blood loss between control group and other two groups. TXA safety evaluation: No lower extremity deep vein thrombosis or pulmonary embolism occurred in the three groups after operation. There was no significant difference in the operation time between groups. But the length of hospital stay was significantly longer in the control group than in the other groups. Effect of TXA on blood coagulation and inflammatory response: The incisions of the 3 groups healed by first intention, and no infections occurred.
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Using tranexamic acid for an additional 24 hours postoperatively in hip and knee arthroplasty saves money: a cost analysis from the TRAC-24 randomized control trial
Karayiannis PN, Agus A, Bryce L, Hill JC, Beverland D
Bone & joint open. 2022;3(7):536-542
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Abstract
AIMS: Tranexamic acid (TXA) is now commonly used in major surgical operations including orthopaedics. The TRAC-24 randomized control trial (RCT) aimed to assess if an additional 24 hours of TXA postoperatively in primary total hip (THA) and total knee arthroplasty (TKA) reduced blood loss. Contrary to other orthopaedic studies to date, this trial included high-risk patients. This paper presents the results of a cost analysis undertaken alongside this RCT. METHODS TRAC-24 was a prospective RCT on patients undergoing TKA and THA. Three groups were included: Group 1 received 1 g intravenous (IV) TXA perioperatively and an additional 24-hour postoperative oral regime, Group 2 received only the perioperative dose, and Group 3 did not receive TXA. Cost analysis was performed out to day 90. RESULTS Group 1 was associated with the lowest mean total costs, followed by Group 2 and then Group 3. The differences between Groups 1 and 3 (-£797.77 (95% confidence interval -1,478.22 to -117.32) were statistically significant. Extended oral dosing reduced costs for patients undergoing THA but not TKA. The reduced costs in Groups 1 and 2 resulted from reduced length of stay, readmission rates, emergency department attendances, and blood transfusions. CONCLUSION This study demonstrated significant cost savings when using TXA in primary THA or TKA. Extended oral dosing reduced costs further in THA but not TKA. Cite this article: Bone Jt Open 2022;3(7):536-542.
PICO Summary
Population
Patients undergoing primary total hip (THA) and total knee arthroplasty (TKA) enrolled in the TRAC-24 trial (n= 1,081).
Intervention
Intravenous perioperative dose of tranexamic acid (TXA) and an additional 24-hour post-operative oral regime (Group 1, n= 471).
Comparison
Intravenous perioperative dose of TXA (Group 2, n= 476). Standard care (Group 3, n= 134).
Outcome
Cost analysis was performed from the day of surgery until 90 days post-surgery. Group 1 was associated with the lowest mean total costs, followed by Group 2 and then Group 3. The difference between Groups 1 and 3 (-£797.77) was statistically significant. Extended oral dosing reduced costs for patients undergoing THA but not TKA. The reduced costs in Groups 1 and 2 resulted from reduced length of stay, readmission rates, emergency department attendances, and blood transfusions.
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Preemptive antifibrinolysis: its role and efficacy in hip-fracture patients undergoing total hip arthroplasty
Liu J, Lei Y, Liao J, Liang X, Hu N, Huang W
The Journal of arthroplasty. 2021
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Editor's Choice
Abstract
BACKGROUND We aimed to determine the efficacy of preemptive antifibrinolysis with tranexamic acid (TXA) in decreasing hidden blood loss (HBL) in the elderly hip fracture patients. METHODS 96 elderly hip fracture patients receiving hip arthroplasty were randomized to receive 100 ml of normal-saline (Group A) or 1.5 g of TXA (Group B) intravenously q12h from post-admission day 1 (PAD1) to the day before surgery. Both groups were treated with 1.5 g of TXA q12h from postoperative day 1 (POD1) to POD3. HBL was calculated by formulas and recorded as the primary outcome. RESULTS In overall analyses, no difference was found in HBL, while the decline-of-hemoglobin (ΔHb), allogeneic-blood-transfusion (ABT) rate, fibrinogen-degradation-product (FDP, on PAD2, PAD3, POD1 and POD2) and D-dimer (D-D, on PAD2, PAD3 and POD1) were lower in Group B. In subgroup analyses for patients receiving intervention within 72 hours of injury, Group B had lower postoperative HBL, ΔHb, ABT rate, FDP and D-D levels (on PAD2, PAD3, POD1 and POD2). For patients receiving intervention over 72 hours after injury, no difference was detected in perioperative HBL, ΔHb, ABT rate between the two groups. The FDP and D-D levels were lower in Group B on PAD2 and PAD3. No difference was found in coagulation parameters, wound complications, VTE rate and 90-day mortality in all analyses. CONCLUSION Early administration (within 72 hours of injury) of multi-dose of TXA is effective in reducing perioperative HBL in elderly hip fracture patients. Delayed use (over 72 hours after injury) of TXA was not beneficial.
PICO Summary
Population
Elderly hip fracture patients undergoing total hip arthroplasty (n= 96).
Intervention
Intravenous tranexamic acid (TXA) every 12 hours from post-admission day to the day before surgery (n= 48).
Comparison
Normal saline (n= 48).
Outcome
No difference was found in hidden blood loss, while the decline-of-haemoglobin (ΔHb), allogeneic-blood-transfusion (ABT) rate, fibrinogen-degradation-product and D-dimer were lower in patients receiving TXA. For patients receiving intervention over 72 hours after injury, no difference was detected in perioperative hidden blood loss, ΔHb, ABT rate between the two groups. No difference was found in coagulation parameters, wound complications, venous thromboembolism rate and 90-day mortality.
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Oral tranexamic acid for an additional 24 hours postoperatively versus a single preoperative intravenous dose for reducing blood loss in total hip arthroplasty: results of a randomized controlled trial (TRAC-24)
Magill P, Hill JC, Bryce L, Martin U, Dorman A, Hogg R, Campbell C, Gardner E, McFarland M, Bell J, et al
The bone & joint journal. 2021;103-b(7):1197-1205
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Editor's Choice
Abstract
AIMS: A typical pattern of blood loss associated with total hip arthroplasty (THA) is 200 ml intraoperatively and 1.3 l in the first 48 postoperative hours. Tranexamic acid (TXA) is most commonly given as a single preoperative dose only and is often withheld from patients with a history of thromboembolic disease as they are perceived to be "high-risk" with respect to postoperative venous thromboembolism (VTE). The TRanexamic ACid for 24 hours trial (TRAC-24) aimed to identify if an additional 24-hour postoperative TXA regime could further reduce blood loss beyond a once-only dose at the time of surgery, without excluding these high-risk patients. METHODS TRAC-24 was a prospective, phase IV, single centre, open label, parallel group, randomized controlled trial (RCT) involving patients undergoing primary unilateral elective THA. The primary outcome measure was the indirect calculated blood loss (IBL) at 48 hours. The patients were randomized into three groups. Group 1 received 1 g intravenous (IV) TXA at the time of surgery and an additional oral regime for 24 hours postoperatively, group 2 only received the intraoperative dose, and group 3 did not receive any TXA. RESULTS A total of 534 patients were randomized, with 233 in group 1, 235 in group 2, and 66 in group 3; 92 patients (17.2%) were considered high-risk. The mean IBL did not differ significantly between the two intervention groups (848.4 ml (SD 463.8) for group 1, and 843.7 ml (SD 478.7) for group 2; mean difference -4.7 ml (95% confidence interval -82.9 to 92.3); p = 0.916). No differences in mortality or incidence of VTE were observed between any group. CONCLUSION The addition of oral TXA for 24 hours postoperatively does not reduce blood loss beyond that achieved with a single 1 g IV perioperative dose alone. There may be a clinically relevant difference in patients with a normal BMI, which warrants further investigation. Critically, there were no safety issues in patients with a history of thromboembolic, cardiovascular, or cerebrovascular disease. Cite this article: Bone Joint J 2021;103-B(7):1197-1205.
PICO Summary
Population
Patients undergoing total hip arthroplasty enrolled in the TRAC-24 trial (n= 534).
Intervention
Intravenous tranexamic acid at the time of surgery and an additional oral regime postoperatively (Group 1, n= 233); intraoperative dose alone (Group 2, n= 235).
Comparison
Did not receive TXA (n= 66).
Outcome
92 patients (17.2%) were considered high-risk. The mean indirect calculated blood loss did not differ significantly between the two intervention groups (848.4 ml (SD 463.8) for group 1, and 843.7 ml (SD 478.7) for group 2; mean difference -4.7 ml. No differences in mortality or incidence of venous thromboembolism were observed between any group.
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Comparison of single versus double tranexamic acid dose regimens in reducing post-operative blood loss following intramedullary nailing of femoral fracture nonunions
Shodipo OM, Jatto HI, Ramat AM, Ibrahim SS, Ajiboye LO, Arojuraye SA, James JA, Toluse AM
International orthopaedics. 2021
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INTRODUCTION AND AIM OF STUDY Tranexamic acid has been found to be effective in reducing peri-operative blood loss and is widely used across surgical specialties including orthopaedic surgery. However, there is still no consensus on the most appropriate and effective dose regimen. This study therefore compared the efficacy of single versus double dose regimens in patients that had interlocking intramedullary nailing by assessing the volume of drain output with the objective of determining the more effective regimen. METHODS The study was a multicenter prospective study amongst adult patients who had interlocking intramedullary nailing for femoral nonunions. Following ethical approval, consent was obtained from eligible patients who were randomly assigned into two study groups. Group A patients had single pre-incision tranexamic acid bolus of one gram while group B patients had a second (repeat) one gram bolus (at the completion of wound closure). The volume of drain output at 48 h postop was the primary outcome measure and data collection was via an online data collection form linked to the google drive of the principal investigator. The mean of the drain output of the two groups was compared for statistical significance. RESULTS A total of 61 patients participated in the study with 30 patients in group A and 31 patients in group B. The demographic data and duration of fracture were comparable in the two groups. Group A had a mean drain volume of 274.80 ml (± 103.93 ml) while group B had a mean of 187.94 ml (± 41.95 ml) and the difference was found to be statistically significant. (P, 0.000). CONCLUSION The findings suggest that double dose perioperative tranexamic acid regimen is superior to single-dose peri-operative tranexamic acid regimen in reducing post-operative blood loss in patients undergoing interlocking intramedullary nailing for femoral nonunions.
PICO Summary
Population
Patients undergoing open interlocking intramedullary nailing of femoral fracture nonunions (n= 61).
Intervention
Single dose of tranexamic acid – at pre-incision (Group A, n= 30).
Comparison
Double dose of tranexamic acid – at pre-incision and at the completion of wound closure (Group B, n= 31).
Outcome
Group A had a mean drain volume of 274.80 ml (± 103.93 ml) while group B had a mean of 187.94 ml (± 41.95 ml) and the difference was found to be statistically significant.
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Effectiveness of different doses and routes of administration of tranexamic acid for total hip replacement
Palija S, Bijeljac S, Manojlovic S, Jovicic Z, Jovanovic M, Cvijic P, Dragicevic-Cvjetkovic D
Int Orthop. 2020
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Editor's Choice
Abstract
PURPOSE The aim of the study is to show the therapeutic efficacy, safety, and cost-benefit of using tranexamic acid (TXA), as well as the superiority of the route of administration and amount of dose in primary cementless total hip replacement (THR). METHODS In this prospective, randomized, double-blind study, we divided 200 patients into five groups of 40 patients each. The placebo group did not receive TXA. Three groups received 2 g TXA each (intravenous, topical, and combined intravenous + topical), while the fifth, combined + group, received 4 g TXA. Total blood loss was calculated, number of transfusions and thromboembolic vascular incidents were monitored, and a cost-benefit analysis of the use of TXA was performed. RESULTS Regardless of the route of administration, TXA statistically significantly reduced total blood loss (p = 0.000) and the need for transfusion (p = 0.000) compared with placebo. Total blood loss and the need for allogenic blood transfusion were statistically significantly reduced in the combined + group compared with placebo, and also compared with all other groups. Post-operative thromboembolic vascular incidents were not reported. The cost-benefit of using TXA in THR is associated with reduction of transfusion costs. CONCLUSIONS None of the TXA administration routes are superior to others, but multiple doses could statistically significantly reduce blood loss and transfusion requirements, which should be the subject of future researches.
PICO Summary
Population
Patients undergoing total hip replacement (n=200).
Intervention
2g intravenous tranexamic acid (TXA) (n=40), 2g topical TXA (n=40), 2g combined intravenous and topical (n=40).
Comparison
4g TXA combined intravenous and topical (n=40), Placebo (n=40).
Outcome
Regardless of the route of administration, TXA statistically significantly reduced total blood loss, and the need for transfusion compared with placebo. Total blood loss and the need for allogenic blood transfusion were statistically significantly reduced in the combined + group compared with placebo, and also compared with all other groups. Post-operative thromboembolic vascular incidents were not reported. The cost-benefit of using TXA in THR is associated with reduction of transfusion costs.
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Tranexamic acid use in high-risk blood transfusion patients undergoing total hip replacement: a randomised controlled trial
Kimura OS, Freitas EH, Duarte ME, Cavalcanti AS, Fernandes MB
Hip international : the journal of clinical and experimental research on hip pathology and therapy. 2019;:1120700019889947
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Editor's Choice
Abstract
INTRODUCTION We hypothesised that a single preoperative intravenous dose of tranexamic acid (TXA) is effective in patients who undergo total hip arthroplasty (THA) and are at high risk of blood transfusion (preoperative haemoglobin level <13.0 g/dL). METHODS A prospective, randomised controlled study of 308 patients who underwent primary THA was conducted. 256 participants remained in the study and were divided into 2 major groups: high-risk group comprising 116 patients with preoperative Hb < 13.0 g/dL (57 of whom were treated with a 15 mg/kg intravenous bolus of TXA, and 59 of whom did not receive the medication) and low-risk group comprising 140 patients with Hb 13.0 g/dL (71 of whom received the same dose of TXA, and 69 of whom did not). Participants were followed up at 3 weeks, 3 months, 6 months, and 1 year after surgery. RESULTS The use of TXA in both groups of patients significantly increased the levels of postoperative Hb and Ht. TXA protected high-risk patients from blood loss and from transfusion. In low-risk patients the use of TXA reduced blood loss but did not protect from blood transfusion. The median length of stay was significantly affected for high-risk patients. No thromboembolic event was recorded in either group. CONCLUSIONS TXA reduces intra- and postoperative bleeding, transfusion rates, and the length of hospital stays in patients with low preoperative Hb. The use of TXA in patients with normal preoperative Hb reduces blood loss but does not affect the transfusion rate. ClinicalTrials.gov Identifier: NCT03019198.
PICO Summary
Population
Patients who underwent primary total hip arthroplasty (THA), (n=256).
Intervention
High-risk group, (n=116). Treated with a 15 mg/kg intravenous bolus of TXA, (n=57), and (n=59) did not receive the medication).
Comparison
Low-risk group, (n=140). Received the same dose of TXA, (n=71), and (n=69) did not).
Outcome
The use of TXA in both groups of patients significantly increased the levels of postoperative Hb and Ht. TXA protected high-risk patients from blood loss and from transfusion. In low-risk patients the use of TXA reduced blood loss but did not protect from blood transfusion. The median length of stay was significantly affected for high-risk patients. No thromboembolic event was recorded in either group.