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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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Ferric derisomaltose and tranexamic acid, combined or alone, for reducing blood transfusion in patients with hip fracture (the HiFIT trial): a multicentre, 2 × 2 factorial, randomised, double-blind, controlled trial
Lasocki, S., Capdevila, X., Vielle, B., Bijok, B., Lahlou-Casulli, M., Collange, V., Grillot, N., Danguy des Deserts, M., Duchalais, A., Delannoy, B., et al
The Lancet. Haematology. 2023
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BACKGROUND Anaemia and blood transfusion are associated with poor outcomes after hip fracture. We evaluated the efficacy of intravenous iron and tranexamic acid in reducing blood transfusions after hip fracture surgery. METHODS In this double-blind, randomised, 2 × 2 factorial trial, we recruited adults hospitalised for hip fractures in 12 medical centres in France who had preoperative haemoglobin concentrations between 9·5 and 13·0 g/dL. We randomly allocated participants (1:1:1:1), via a secure web-based service, to ferric derisomaltose (20 mg/kg intravenously) and tranexamic acid (1 g bolus followed by 1 g over 8 h intravenously at inclusion and 3 g topically during surgery), iron plus placebo (normal saline), tranexamic acid plus placebo, or double placebo. Unmasked nurses administered study drugs; participants and other clinical and research staff remained masked to treatment allocation. The primary outcome was the percentage of patients transfused during hospitalisation (or by day 30). The primary analysis included all randomised patients. This study is registered on ClinicalTrials.gov (NCT02972294) and is closed to new participants. FINDINGS Of 413 patients (51-104 years old, median [IQR] 86 [78-91], 312 [76%] women, 101 [24%] men), 104 received iron plus tranexamic acid, 103 iron plus placebo, 103 tranexamic acid plus placebo, and 103 double placebo between March 31, 2017 and June 18, 2021 (study stopped early for efficacy after the planned interim analysis done on the first 390 patients included on May 25, 2021). Data for the primary outcome were available for all participants. Among patients on double placebo, 31 (30%) were transfused versus 16 (15%) on both drugs (relative risk 0·51 [98·3% CI 0·27-0·97]; p=0·012). 27 (26%) participants on iron (0·81 [0·50-1·29]; p=0·28) and 28 (27%) on tranexamic acid (0·85 [0·54-1·33]; p=0·39) were transfused. 487 adverse events were reported with similar event rates among the groups; among prespecified safety endpoints, severe postoperative anaemia (haemoglobin <8 g/dL) was more frequent in the double placebo group. Main common adverse event were sepsis, pneumonia, and urinary infection, with similar rates among all groups. INTERPRETATION In patients hospitalised for hip fracture surgery with a haemoglobin concentration 9·5-13·0 g/dL, preoperative infusion of ferric derisomaltose plus tranexamic acid reduced the risk of blood transfusion by 50%. Our results suggest that combining treatments from two different pillars improves patient blood-management programmes. Either treatment alone did not reduce transfusion rates, but we might not have had the power to detect it. FUNDING French Ministry of Health, HiFIT trial.
PICO Summary
Population
Adults hospitalised for hip fractures in 12 medical centres in France, enrolled in the Hip Fracture Iron and Tranexamic acid (HiFIT) trial (n= 413).
Intervention
Iron plus tranexamic acid (n= 104).
Comparison
Iron plus placebo (n= 103). Tranexamic acid plus placebo (n= 103). Double placebo (n= 103).
Outcome
Among patients on double placebo, 31 (30%) were transfused vs. 16 (15%) on both drugs (relative risk 0.51; 98.3% CI [0.27, 0.97]); 27 (26%) participants on iron (relative risk 0.81; 98.3% CI [0.50, 1.29]) and 28 (27%) on tranexamic acid (relative risk 0.85; 98.3% CI [0.54, 1.33]) were transfused. 487 adverse events were reported with similar event rates among the groups; among prespecified safety endpoints, severe postoperative anaemia (haemoglobin <8 g/dL) was more frequent in the double placebo group. Main common adverse events were sepsis, pneumonia, and urinary infection, with similar rates among all groups.
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IRON NOF trial: IV iron for anaemic patients with femoral fracture
O'Loughlin, E., Chih, H., Sivalingam, P., Symons, J., Godsall, G., MacLean, B., Richards, T.
BJA open. 2023;7:100222
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Editor's Choice
Abstract
BACKGROUND Preoperative anaemia is associated with increased use of blood transfusions, a greater risk of postoperative complications, and patient morbidity. The IRON NOF trial aimed to investigate whether the administration of i.v. iron in anaemic patients during hip fracture surgery reduced the need for blood transfusion and improved patient outcomes. METHODS This phase III double-blind, randomised, placebo-controlled trial included patients >60 yr old with preoperative anaemia undergoing surgery for femoral neck or subtrochanteric fracture across seven Australian Hospitals. Patients were randomly allocated on a 1:1 basis to receive either i.v. iron carboxymaltose 1000 mg or placebo (saline) at operation. The primary endpoint was blood transfusion use, with secondary endpoints of haemoglobin concentration at 6 weeks, length of hospital stay, rehabilitation duration to discharge, and 6-month mortality. Subgroup analysis compared outcomes in patients <80 yr old and patients >80 yr old. All analyses were performed by intention-to-treat. This trial was terminated early because of jurisdictional changes of more restrictive transfusion practices and changes in consent requirements. RESULTS Participants (n=143) were recruited between February 2013 and May 2017. There was no difference observed in the incidence of blood transfusion between the treatment group (18/70) (26%) compared with the placebo group (27/73) (37%) (odds ratio for transfusion if receiving placebo: 1.70; 95% confidence interval [CI] 0.83-3.47; P=0.15) and there was no overall difference in the median number of blood units transfused between groups (odds ratio 1.52; 95% CI 0.77-3.00; P=0.22). Patients receiving i.v. iron had a higher haemoglobin 6 weeks after intervention compared with the placebo group (Hb 116 g L(-1)vs 108 g L(-1); P=0.01). No difference was observed in length of hospital stay, rehabilitation duration to discharge, or 6-month mortality. However, in younger patients without major bleeding, the use of placebo compared with i.v. iron was associated with an increased number of units of blood transfused (placebo transfusion incidence rate ratio 3.88; 95% CI 1.16-13.0; P=0.03). CONCLUSIONS In anaemic patients undergoing surgery for hip fracture, i.v. iron did not reduce the overall proportion of patients receiving blood transfusion. The use of i.v. iron may reduce the amount of blood transfused in younger patients. The use of i.v. iron is associated with increased haemoglobin concentrations 6 weeks after the operation. CLINICAL TRIAL REGISTRATION ACTRN12612000448842.
PICO Summary
Population
Patients with preoperative anaemia undergoing surgery for femoral neck or subtrochanteric fracture, enrolled in the IRON NOF trial across seven Australian hospitals (n= 143).
Intervention
Intravenous iron carboxymaltose (n= 70).
Comparison
Placebo (saline), (n= 73).
Outcome
All analyses were performed by intention-to-treat. The trial was terminated early because of jurisdictional changes of more restrictive transfusion practices and changes in consent requirements. There was no difference observed in the incidence of blood transfusion between the treatment group 18/70 (26%) compared with the placebo group 27/73 (37%), (odds ratio for transfusion if receiving placebo: 1.70; 95% confidence interval (CI) [0.83, 3.47]) and there was no overall difference in the median number of blood units transfused between groups (odds ratio 1.52; 95% CI [0.77, 3.00]). Patients receiving intravenous iron had a higher haemoglobin 6 weeks after intervention compared with the placebo group (Hb 116 g L(-1) vs. 108 g L(-1)). No difference was observed in length of hospital stay, rehabilitation duration to discharge, or 6-month mortality. In younger patients without major bleeding, the use of placebo compared with intravenous iron was associated with an increased number of units of blood transfused (placebo transfusion incidence rate ratio 3.88; 95% CI [1.16, 13.0]).
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Perioperative blood loss reduction using a sterile exsanguination tourniquet for orthopedic femoral-related surgeries in children: a randomized controlled study
Rattanathanya, T., Adulkasem, N., Wongcharoenwatana, J., Ariyawatkul, T., Chotigavanichaya, C., Eamsobhana, P.
Journal of orthopaedic surgery and research. 2023;18(1):580
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Abstract
OBJECTIVES The sterile exsanguination tourniquet (SET) could be an alternative for providing bloodless surgeries in orthopedic femoral-related surgeries in pediatric patients where the standard pneumatic tourniquet would not be feasible. This randomized-controlled study aimed to evaluate the efficacy of SET in decreasing total perioperative blood loss and blood transfusion. METHODS We conducted an unplanned interim analysis of data from a randomized-controlled trial. At the time of the analysis, 31 pediatric patients had been randomly assigned to undergo surgery with the SET application (the SET group, 15 patients) and without the SET application (the control group, 16 patients). An intention-to-treat analysis was performed to evaluate the total perioperative blood loss, postoperative blood transfusion, estimated intraoperative blood loss, total drainage volume, postoperative hemoglobin level, and operative time according to the significance level adjusted for multiplicity (p < 0.029). RESULTS There was a borderline statistically significant lower body weight-adjusted TBL in the SET group (SET = 14.1 (7.7, 16.9) ml/kg vs. control 18.3 (14.8, 37.2) ml/kg, p-value = 0.027). The body weight-adjusted transfusion volume was statistically significantly greater in the control group (SET = 0.0 (0.0, 0.0) ml/kg vs. control = 2.1 (0.0, 9.7) ml/kg, p = 0.017). Body weight-adjusted estimated intraoperative blood loss was significantly lower in the SET group (SET = 0.8 (0.2, 3.5) ml/kg vs. control = 5.6 (3.4, 21.5) ml/kg, p < 0.001). In addition, the operative time was lower in the SET group with borderline statistical significance (SET = 105 (85.0, 125.0) vs. control = 130 (101.3, 167.5), p = 0.039). CONCLUSION Utilization of a sterile exsanguination tourniquet (SET) significantly reduced an estimated intraoperative blood loss while preventing the need for blood transfusion after pediatric orthopedic femoral-related surgeries. Trial registration TCTR20220412003.
PICO Summary
Population
Paediatric patients aged 3 to 18 undergoing elective femoral-related surgery (n= 31).
Intervention
Sterile exsanguination tourniquet (SET), (SET group, n= 15).
Comparison
No SET (Control group, n= 16).
Outcome
The primary outcomes were perioperative total blood loss (TBL) and transfusion rate at 72 hours after surgery. There was a borderline statistically significant lower body weight-adjusted TBL in the SET group (SET= 14.1 (7.7, 16.9) ml/kg vs. control 18.3 (14.8, 37.2) ml/kg). The body weight-adjusted transfusion volume was statistically significantly greater in the control group (SET= 0.0 (0.0, 0.0) ml/kg vs. control= 2.1 (0.0, 9.7) ml/kg). Body weight-adjusted estimated intraoperative blood loss was significantly lower in the SET group (SET= 0.8 (0.2, 3.5) ml/kg vs. control= 5.6 (3.4, 21.5) ml/kg). The operative time was lower in the SET group with borderline statistical significance (SET= 105 (85.0, 125.0) vs. control= 130 (101.3, 167.5)).
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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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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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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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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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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.