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Effectiveness of Tranexamic Acid in the Postoperative Period in Body Contour Surgery: Randomized Clinical Trial
Bayter-Marín, J. E., Hoyos, A., Cárdenas-Camarena, L., Peña-Pinzón, W., Bayter-Torres, A. F., Díaz-Díaz, C. A., McCormick-Méndez, M., Plata-Rueda, E. L., Niño-Carreño, C. S.
Plastic and reconstructive surgery. Global open. 2023;11(11):e5403
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Abstract
BACKGROUND Tranexamic acid (TXA) is used to reduce bleeding in body contouring procedures; however, there are no studies that show the effectiveness of TXA when it is also used in the immediate postoperative period. METHODS A controlled, randomized, parallel, and open-label clinical trial was carried out in adult patients undergoing liposculpture and/or abdominoplasty. A control group administering presurgical TXA and a study group with presurgical and postsurgical TXA were formed. The decrease in hemoglobin and the incidence of blood transfusions between both groups were compared as well as the possible adverse effects of TXA. RESULTS Four hundred twenty-seven subjects were included, 208 (48.7%) in the control group and 219 (51.3%) in the study group. The median age was 34 years (interquartile range 28-42). Median postoperative hemoglobin levels at 24 hours were similar in both groups (study 11.3 g/dL versus control 11.1 g/dL, P = 0.07); however, at 72 hours, postoperative hemoglobin was higher in the study group versus control (10.8 versus 10.0 g/dL, P ≤ 0.001). The incidence of transfusions at 72 hours was 1.8% in the study group and 8.6% in the control group, for a risk ratio of 0.21 (95% confidence interval 0.07-0.61). There were no adverse or thromboembolic events. CONCLUSION TXA proved to be more effective in reducing intra- and postsurgical bleeding and the need for transfusions, when used preoperatively and continued for 48 hours after surgery, than when used only preoperatively, without reporting adverse or thromboembolic effects.
PICO Summary
Population
Patients undergoing liposculpture and/or abdominoplasty (n= 427).
Intervention
Presurgical and postsurgical tranexamic acid (TXA), (study group, n= 219).
Comparison
Presurgical TXA (control group, n= 208).
Outcome
Median postoperative haemoglobin levels at 24 hours were similar in both groups (study 11.3 g/dL versus control 11.1 g/dL). At 72 hours, postoperative haemoglobin was higher in the study group versus control (10.8 versus 10.0 g/dL). The incidence of transfusions at 72 hours was 1.8% in the study group and 8.6% in the control group, for a risk ratio of 0.21; 95% confidence interval [0.07, 0.61]. There were no adverse or thromboembolic events.
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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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Evaluation of the Safety and Effectiveness of Topical Intrapleural Application of Tranexamic Acid in Thoracic Surgery: A Systematic Review and Meta-Analysis of Randomized Controlled Trials
Alzahrani, A., Alkofide, H., Joharji, H., Korayem, G. B., Aljohani, S., Alshareef, H., AlFaifi, M., Alalawi, H., Sulaiman, K. A.
Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis. 2023;29:10760296231218215
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Editor's Choice
Abstract
OBJECTIVES Bleeding remains a common complication post-thoracic surgery. Although intravenous tranexamic acid (TXA) has been shown to decrease blood loss, its use has been associated with adverse effects. Accordingly, topical TXA has been proposed as an alternative to reduce bleeding with fewer systemic complications. METHODS We searched Medline, Embase, and Cochrane Central databases for randomized controlled trials (RCTs) comparing topical TXA versus control (i.e., placebo) in patients undergoing thoracic procedures. The primary outcome was total postoperative blood loss at 24 hours. Secondary outcomes included were the number of red blood cell (RBC) transfusions, and hospital length of stay (LOS). Meta-analyses were pooled using mean difference with inverse-variance weighting and random-effects. RESULTS Out of the 575 unique studies that were screened, we identified three randomized controlled trials (RCTs) involving 399 patients. Out of the three RCTs analyzed, two studies, accounting for 67% of the total, were found to have a low risk of bias. The primary outcome of 24-h post-operative blood loss was significantly lower in patients who received TXA (mean difference [MD] -93.6 ml, 95% CI -121.8 to -65.4 ml, I(2 )= 45%). In addition, the need for RBC transfusion was significantly lower in the topical TXA group compared to control (MD -0.5 units, 95% CI -0.8 to -0.3 units, I(2 )= 60%). However, there was no significant difference in the hospital length of stay (LOS) (MD -0.3 days, 95% CI -0.9 to 0.4 days, I(2 )= 0%). These results remained consistent after several sensitivity analyses. The use of topical intrapleural tranexamic acid has also been found to be safe without any significant safety concerns. CONCLUSION Topical intrapleural TXA reduces blood loss and the need for blood transfusions during thoracic surgery. In addition, there is no evidence of the increased safety concerns associated with its use. Larger trials are necessary to validate these findings and evaluate the safety and efficacy of different dosages.
PICO Summary
Population
Patients undergoing thoracic surgery procedures (3 randomised controlled trials, n= 399).
Intervention
Topical intrapleural tranexamic acid (TXA).
Comparison
Placebo.
Outcome
The primary outcome of postoperative blood loss at 24 hours was significantly lower in patients who received TXA (mean difference [MD] -93.6 ml; 95% CI [-121.8, -65.4 ml], I(2)= 45%). The need for red blood cell transfusion was significantly lower in the topical TXA group compared to control (MD -0.5 units; 95% CI [-0.8, -0.3 units], I(2)= 60%). There was no significant difference in the hospital length of stay, (MD -0.3 days; 95% CI [-0.9, 0.4 days], I(2)= 0%). These results remained consistent after several sensitivity analyses.
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Tranexamic acid for percutaneous nephrolithotomy
Cleveland, B., Norling, B., Wang, H., Gandhi, V., Price, C. L., Borofsky, M. S., Pais, V., Dahm, P.
The Cochrane database of systematic reviews. 2023;10(10):Cd015122
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Abstract
BACKGROUND Percutaneous nephrolithotomy (PCNL) is the gold standard for the treatment of large kidney stones but comes with an increased risk of bleeding compared to other treatments, such as ureteroscopy and shock wave lithotripsy. Tranexamic acid (TXA) is an antifibrinolytic agent that has been used to reduce bleeding complications in other settings. OBJECTIVES To assess the effects of TXA in individuals with kidney stones undergoing PCNL. SEARCH METHODS We performed a comprehensive literature search of the Cochrane Library, PubMed (including MEDLINE), Embase, Scopus, Global Index Medicus, trials registries, other sources of the grey literature, and conference proceedings. We applied no restrictions on the language of publication nor publication status. The latest search date was 11 May 2023. SELECTION CRITERIA We included randomized controlled trials (RCTs) that compared treatment with PCNL with administration of TXA to placebo (or no TXA) for patients ≥ 18 years old. DATA COLLECTION AND ANALYSIS Two review authors independently classified studies and abstracted data. Primary outcomes were: blood transfusion, stone-free rate (SFR), and thromboembolic events (TEEs). Secondary outcomes were: adverse events (AEs), secondary interventions, major surgical complications, minor surgical complications, unplanned hospitalizations or readmissions, and hospital length of stay (LOS). We performed statistical analyzes using a random-effects model. We rated the certainty of evidence (CoE) according to the GRADE approach using a minimally contextualized approach with predefined thresholds for minimally clinically important differences (MCIDs). MAIN RESULTS We analyzed 10 RCTs assessing the effect of systemic TXA in PCNL versus placebo (or no TXA) with 1883 randomized participants. Eight studies were published as full text. One was published in abstract proceedings, but it was separated into two separate studies for the purpose of our analyzes. Average stone surface area ranged 3.45 to 6.62 cm(2). We also found a single RCT published in full text assessing the effects of topical TXA in PCNL versus placebo (or no TXA) with 400 randomized participants, the results of which are further described in the review. Here we focus only on the results of TXA used systemically. Blood transfusion - Based on a representative baseline risk of 5.7% for blood transfusions taken from a large presentative observational studies, systemic TXA may reduce blood transfusions (risk ratio (RR) 0.45, 95% confidence interval (CI) 0.27 to 0.76; I(2) = 28%; 9 studies, 1353 participants; low CoE). We assumed an MCID of ≥ 2%. Based on 57 participants per 1000 with placebo (or no TXA) being transfused, this corresponds to 31 fewer (from 42 fewer to 14 fewer) participants being transfused per 1000. Stone-free rate - Based on a representative baseline risk of 75.7% for SFR, systemic TXA may increase SFRs (RR 1.11, 95% CI 0.98 to 1.27; I(2) = 62%; 4 studies, 603 participants; low CoE). We assumed an MCID of ≥ 5%. Based on 757 participants per 1000 being stone free with placebo (or no TXA), this corresponds to 83 more (from 15 fewer to 204 more) stone-free participants per 1000. Thromboembolic events - There is probably no difference in TEEs (risk difference (RD) 0.00, 95% CI -0.01 to 0.01; I(2) = 0%; 6 studies, 841 participants; moderate CoE). We assumed an MCID of ≥ 2%. Since there were no thromboembolic events in intervention and/or control groups in 5 out of6 studies, we opted to assess a risk difference with systemic TXA for this outcome. Adverse events - Systemic TXA may increase AEs (RR 5.22, 95% CI 0.52 to 52.72; I(2) = 75%; 4 studies, 602 participants; low CoE). We assumed an MCID of ≥ 5%. Based on 23 participants per 1000 with placebo (or no TXA) having an adverse event, this corresponds to 98 more (from 11 fewer to 1000 more) participants with adverse events per 1000. Secondary interventions - Systemic TXA may have little to no effect on secondary interventions (RR 1.15, 95% CI 0.84 to 1.57; I(2) = 0%; 2 studies, 319 participants; low CoE). We assumed an MCID of ≥ 5%. Based on 278 participants per 1000 with placebo (or no TXA) having a secondary intervention, this corresponds to 42 more (from 44 fewer to 158 more) participants with secondary interventions per 1000. Major surgical complications - Based on a representative baseline risk for major surgical complications of 4.1%, systemic TXA may reduce major surgical complications (RR 0.36, 95% CI 0.21 to 0.62; I(2) = 0%; 5 studies, 733 participants; moderate CoE). We assumed an MCID of ≥ 2%. Based on 41 participants per 1000 with placebo (or no TXA) having a major surgical complication, this corresponds to 26 fewer (from 32 fewer to 16 fewer) participants with major surgical complications per 1000. Minor surgical complications - Systemic TXA may reduce minor surgical complications (RR 0.71, 95% CI 0.45 to 1.10; I(2) = 76%; 5 studies, 733 participants; low CoE). We assumed an MCID of ≥ 5%. Based on 396 participants per 1000 with placebo (or no TXA) having a minor surgical complication, this corresponds to 115 fewer (from 218 fewer to 40 more) participants with minor surgical complications per 1000. Unplanned hospitalizations or readmissions - We are very uncertain how unplanned hospitalizations or readmissions are affected (RR 1.55, 95% CI 0.45 to 5.31; I(2) = not applicable; 1 study, 189 participants; very low CoE). We assumed an MCID of ≥ 2%. Hospital length of stay - Systemic TXA may reduce hospital LOS (mean difference 0.52 days lower, 95% CI 0.93 lower to 0.11 lower; I(2) = 98%; 7 studies, 1151 participants; low CoE). We assumed an MCID of ≥ 0.5 days. AUTHORS' CONCLUSIONS Based on 10 RCTs with substantial methodological limitations that lowered all CoE of effect, we found that systemic TXA in PCNL may reduce blood transfusions, major and minor surgical complications, and hospital LOS, as well as improve SFRs; however, it may increase AEs. We are uncertain about the effects of systemic TXA on other outcomes. Findings of this review should assist urologists and their patients in making informed decisions about the use of TXA in the setting of PCNL.
PICO Summary
Population
Patients with kidney stones undergoing percutaneous nephrolithotomy (PCNL), (10 randomised controlled trials (RCTs), n= 1,883).
Intervention
Tranexamic acid.
Comparison
Placebo or no tranexamic acid.
Outcome
The primary outcomes were: blood transfusion, stone-free rate, and thromboembolic events. Based on 10 RCTs with substantial methodological limitations that lowered all certainty of evidence of effect, the authors found that systemic tranexamic acid in PCNL may reduce blood transfusions, major and minor surgical complications, and hospital length of stay, as well as improve stone-free rates; however, it may increase adverse events. The authors were uncertain about the effects of systemic TXA on other outcomes.
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Topical Tranexamic Acid in Breast Reconstruction: A Double-Blind, Randomized Controlled Trial
Safran T, Vorstenbosch J, Viezel-Mathieu A, Davison P, Dionisopoulos T
Plastic and reconstructive surgery. 2023
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Editor's Choice
Abstract
BACKGROUND Excess fluid accumulation (seroma/hematoma) around the breast implant post reconstruction can lead to significant complications. Topical administration of tranexamic acid (TXA) may reduce fluid accumulation and reduce post-operative complications. This trial aims to investigate if TXA treated mastectomy pockets will exhibit less postoperative fluid production and complications. METHODS This paired, double-blinded, randomized-controlled trial enrolled patients undergoing bilateral mastectomies with immediate direct to implant reconstruction. In each patient, one breast was randomized to receive 3g TXA (100cc), and the other received 100cc of NS. The blinded solutions were soaked in the mastectomy pocket for five minutes before implant placement. Postoperatively, daily drain outputs, complications, and baseline demographics were recorded. RESULTS 53 eligible patients, representing 106 breasts, were enrolled. All patients underwent bilateral nipple-sparing mastectomies. After randomization, TXA was placed in the right breast in 56.6% (n=30) of patients. The use of topical TXA resulted in a mean drain output reduction of 30.5% (RANGE -83.6% - 26.6%). Drains on the TXA treated breast were eligible for removal 1.4(RANGE 0-4) days sooner than the control side. TXA treated group had three complications (5.67%) versus 15 (28.3%) in the control group (Odds Ratio: 0.1920, p= 0.0129). Specifically, for operative hematomas, the TXA group had none(0%) versus three in the control group (5.7%)(Odds Ratio: 0.1348, P=0.18). CONCLUSION Soaking the mastectomy bed with 3% topical TXA before implant insertion leads to a decrease in drain output and a decrease in complications. Topical administration of TXA represents an option to decrease complications in alloplastic breast reconstruction.
PICO Summary
Population
Patients undergoing bilateral mastectomies with immediate direct to implant reconstruction (n= 53, representing 106 breasts).
Intervention
Tranexamic acid (TXA).
Comparison
Normal saline.
Outcome
After randomization, TXA was placed in the right breast in 56.6% (n= 30) of patients. The use of topical TXA resulted in a mean drain output reduction of 30.5% (Range: -83.6% - 26.6%). Drains on the TXA treated breast were eligible for removal 1.4 (Range: 0 - 4) days sooner than the control side. TXA treated group had three complications (5.67%) versus 15 (28.3%) in the normal saline group (Odds Ratio: 0.1920). Specifically, for operative haematomas, the TXA group had none (0%) versus three in the normal saline group (5.7%), (Odds Ratio: 0.1348).
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The effect of tranexamic acid on perioperative blood loss in transurethral resection of the prostate: A double-blind, randomized controlled trial
Vanderbruggen, W., Brits, T., Tilborghs, S., Derickx, K., De Wachter, S.
The Prostate. 2023
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Editor's Choice
Abstract
BACKGROUND Bleeding and bleeding-related complications remain common after bipolar transurethral resection of the prostate (TURP) for benign prostatic hyperplasia. This may possibly lead to prolonged postoperative irrigation, catheterization, and hospital stay. The objective of this trial was to evaluate the effect of high-dose tranexamic acid (TXA) on perioperative blood loss in patients treated with bipolar TURP for prostate sizes between 30 and 80 g. METHODS We conducted a single-center, prospective, double-blind, randomized controlled trial. Eighty patients were screened for inclusion between March 2020 and January 2023. After exclusion, 65 patients were randomized in two comparable groups. The TXA group (31 patients) received a TXA intravenous loading dose of 10 mg/kg over 30 min before induction, followed by a maintenance dose of 5 mg/kg/h over 12 h. The placebo group (34 patients) received an equal dose of saline infusion. We measured age, weight, preoperative prostate size, anticoagulant use, 5-alpha reductase inhibitor use, preoperative urinary tract infection, American Society of Anesthesiologists score, difference in pre- and 24 h postoperative hemoglobin and hematocrit levels, operative time, resected adenoma weight, duration of postoperative irrigation, total amount of postoperative irrigation fluid, indwelling catheter time, duration of hospital stay, blood transfusion rate, and 4-week complication rate. RESULTS Baseline characteristics in both groups were comparable. Postoperative hemoglobin decrease in TXA versus placebo group was 1 versus 1.6 mg/dL, respectively (p = 0.04). In addition, the amount of postoperative irrigation fluid (10.7 vs. 18.5 L), irrigation time (24.3 vs. 37.9 h), catheterization time (40.8 vs. 53.7 h), and hospital stay (46.9 vs. 59.2 h) were statistically significant in favor of TXA use. No blood transfusions were carried out. Four-week complication rate was comparable between the two groups. CONCLUSIONS Perioperative high-dose TXA seems beneficial in reducing hemoglobin loss, postoperative irrigation, catheterization time, and hospital stay in bipolar TURP for prostate sizes between 30 and 80 g, without increased risk of TXA-related thromboembolic events.
PICO Summary
Population
Patients treated with bipolar transurethral resection of the prostate (n= 65).
Intervention
Tranexamic acid (TXA), (n= 31).
Comparison
Placebo (saline infusion), (n= 34).
Outcome
Postoperative haemoglobin decrease in TXA compared to placebo was 1 versus 1.6 mg/dL, respectively. The amount of postoperative irrigation fluid (10.7 vs. 18.5 L), irrigation time (24.3 vs. 37.9 h), catheterization time (40.8 vs. 53.7 h), and hospital stay (46.9 vs. 59.2 h) were statistically significant in favor of TXA use. No blood transfusions were carried out. Four-week complication rate was comparable between the two groups.
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The efficacy and safety of tranexamic acid in lumbar surgery: A meta-analysis of randomized-controlled trials
Xiao K, Zhuo X, Peng X, Wu Z, Li B
Joint diseases and related surgery. 2022;33(1):57-85
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Editor's Choice
Abstract
OBJECTIVES This meta-analysis aims to assess tranexamic acid (TXA) effectiveness and safety in lumbar surgery. PATIENTS AND METHODS Renewals of randomized-controlled trials (RCTs) were conducted utilizing databases of medical literature such as PubMed, China Science and Technology Journal Database, Cochrane Library, China National Knowledge Infrastructure (CNKI), and EMBASE to compare principal and safety endpoints. The risk ratio (RR), standard mean difference (SMD), and 95% confidence intervals (CIs) were calculated. For the evaluation of the quality of the included studies, the Cochrane risk of bias criteria were utilized by two authors. RESULTS In total, 49 articles were enrolled that included 4,822 patients. Of the patients, 2,653 were administered TXA and 2,169 were in the control group. The findings indicated that TXA was capable of significantly lowering postoperative blood loss (PBL), transfusion rate, transfusion volume, total blood loss (TBL), intraoperative blood loss (IBL), and drainage compared to the control group. Besides, hemoglobin (Hb) and hematocrit (Hct) values were higher in the TXA group compared to the control group. As the safety endpoints, TXA significantly reduced D-dimer levels compared to the control group; however, both TXA and control groups had no significant variations in deep venous thrombosis (DVT). Subgroup analysis was administrated according to the administration method of TXA and the operation type and intravenous and topical TXA were combined in the meta-analysis. CONCLUSION This meta-analysis showed that TXA had the potential to significantly lower PBL, transfusion rate, transfusion volume, TBL, IBL, and drainage compared to the control group. Besides, Hb and Hct values were higher in the TXA group compared to the control group. Its hemostatic potential after lumbar spine surgery is trustworthy. It is still controversial in safety endpoints that TXA can significantly reduce D-dimer compared to the control group, without no significant variations in DVT in both the TXA and control groups.
PICO Summary
Population
Patients undergoing lumbar surgery (49 studies, n= 4,822).
Intervention
Tranexamic acid (TXA), (n= 2,653).
Comparison
Normal saline (n= 2,169).
Outcome
TXA significantly lowered postoperative blood loss, transfusion rate, transfusion volume, total blood loss, intraoperative blood loss, and drainage compared to the control group. Haemoglobin and haematocrit values were higher in the TXA group compared to the control group. As the safety endpoints, TXA significantly reduced D-dimer levels compared to the control group; however, both TXA and control groups had no significant variations in deep venous thrombosis.
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Prophylactic Use of Antifibrinolytics During Pediatric Cardiac Surgery With Cardiopulmonary Bypass on Postoperative Bleeding and Transfusion: A Systematic Review and Meta-Analysis
Schertz K, Karam O, Demetres M, Faraoni S, Faraoni D, Nellis ME
Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies. 2022
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Editor's Choice
Abstract
OBJECTIVES To determine the effect of intraoperative antifibrinolytics, including tranexamic acid (TXA), aminocaproic acid (EACA), or aprotinin, on bleeding in children undergoing cardiac surgery with cardiopulmonary bypass (CPB). DATA SOURCES Relevant articles were systematically searched from Ovid MEDLINE, Ovid EMBASE, CINAHL, Cochrane Library, and Web of Science to November 15, 2021. STUDY SELECTION Abstracts were screened, and full texts were reviewed using predetermined inclusion and exclusion criteria using the Preferred Reporting Items for Systematic Reviews and Meta-analyses reporting guideline. DATA EXTRACTION A standardized data extraction tool was used. DATA SYNTHESIS Sixty-eight studies including 28,735 patients were analyzed. TXA compared with placebo resulted in a mean decrease in chest tube output of 9.1 mL/kg (95% CI, 6.0-12.3 mL/kg), I2 equals to 65.2%, p value of less than 0.001, platelet requirement of 2.9 mL/kg (95% CI, 0.1-5.8 mL/kg), I2=72.5%, p value less than 0.001 and plasma requirement of 4.0 mL/kg (95% CI, 0.6-7.2 mL/kg), I2 equals to 94.5%, p value less than0.001. Aprotinin compared with placebo resulted in a mean decrease in chest tube output of 4.3 mL/kg (2.4-6.2 mL/kg), I2 equals to 66.3%, p value of less than 0.001, platelet transfusion of 4.6 mL/kg (95% CI, 0.6-8.6 mL/kg), I2 equals to 93.6%, p value of less than 0.001, and plasma transfusion of 7.7 mL/kg (95% CI, 2.1-13.2 mL/kg), I2 equals to 95.3%, p value of less than 0.001. EACA compared with placebo resulted in a mean decrease in chest tube output of 9.2 mL/kg (2.3-21.0 mL/kg), I2 equals to 96.4%, p value of less than 0.001, RBC transfusion of 7.2 mL/kg (95% CI, 2.4-12.1 mL/kg), I2 equals to 94.5%, p value equals to 0.002, and platelet transfusion of 10.7 mL/kg (95% CI, 2.9-18.5 mL/kg), I2 equals to 0%, p value of less than 0.001. No statistical difference was observed in chest tube output when TXA was compared with aprotinin. Subgroup analysis of cyanotic patients showed a significant decrease in chest tube output, platelet requirement, and plasma requirement for patients receiving aprotinin. Overall, the quality of evidence was moderate. CONCLUSIONS Antifibrinolytics are effective at decreasing blood loss and blood product requirement in children undergoing cardiac surgery with CPB although the quality of evidence is only moderate.
PICO Summary
Population
Children undergoing cardiac surgery with cardiopulmonary bypass, (68 studies, n= 28,735).
Intervention
Intraoperative antifibrinolytics, including tranexamic acid (TXA), aminocaproic acid (EACA), or aprotinin.
Comparison
Placebo.
Outcome
TXA compared with placebo resulted in a mean decrease in chest tube output of 9.1 mL/kg (95% Confidence Interval (CI): 6.0-12.3 mL/kg), platelet requirement of 2.9 mL/kg (95% CI: 0.1-5.8 mL/kg), and plasma requirement of 4.0 mL/kg (95% CI: 0.6-7.2 mL/kg). Aprotinin compared with placebo resulted in a mean decrease in chest tube output of 4.3 mL/kg (2.4-6.2 mL/kg), platelet transfusion of 4.6 mL/kg (95% CI: 0.6-8.6 mL/kg), and plasma transfusion of 7.7 mL/kg (95% CI: 2.1-13.2 mL/kg). EACA compared with placebo resulted in a mean decrease in chest tube output of 9.2 mL/kg (2.3-21.0 mL/kg), red blood cell transfusion of 7.2 mL/kg (95% CI: 2.4-12.1 mL/kg), and platelet transfusion of 10.7 mL/kg (95% CI: 2.9-18.5 mL/kg). Overall, the quality of evidence was moderate.
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Safety and efficacy of aprotinin versus tranexamic acid for reducing absolute blood loss and transfusion in pediatric patients undergoing craniosynostosis surgery: a randomized, double-blind, three-arm controlled trial
Ebrahim Soltani Z, Hanaei S, Dabbagh Ohadi MA, Maroufi SF, Tayebi Meybodi K, Khademi S, Yaghmaei B, Ebrahim Soltani A, Nejat F, Habibi Z
Journal of neurosurgery. Pediatrics. 2022;:1-9
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Editor's Choice
Abstract
OBJECTIVE Craniosynostosis surgery is associated with considerable blood loss and need for transfusion. Considering the lower estimated blood volume (EBV) of children compared to adults, excessive blood loss may quickly lead to hypovolemic shock. Therefore, reducing blood loss is important in craniosynostosis surgery. This study was conducted to evaluate the efficacy of aprotinin or tranexamic acid (TXA) in blood loss reduction in these patients. METHODS In the current randomized controlled trial, 90 eligible pediatric patients with craniosynostosis were randomly divided into three groups to receive either aprotinin, TXA, or no intervention. The absolute blood loss and transfusion amount were assessed for all patients both intraoperatively and 2 and 8 hours postoperatively. RESULTS Although crude values of estimated blood loss were not significantly different between groups (p = 0.162), when adjusted to the patient's weight or EBV, the values reached the significance level (p = 0.018), particularly when the aprotinin group was compared to the control group (p = 0.0154). The EBV losses 2 hours and 8 hours postoperatively significantly dropped in the TXA and aprotinin groups compared to the control group (p = 0.001 and p < 0.001, respectively). Rates of postoperative blood transfusion were significantly higher in the control group (p = 0.024). Hemoglobin and hematocrit 8 hours postoperatively were lower in the control group than in the TXA or aprotinin treatment groups (p < 0.002 and p < 0.001, respectively). There were no serious adverse events associated with the interventions in this study. CONCLUSIONS Aprotinin and TXA can reduce blood loss and blood transfusion without serious complications and adverse events in pediatric patients undergoing craniosynostosis surgery.
PICO Summary
Population
Paediatric patients undergoing craniosynostosis surgery (n= 90).
Intervention
Aprotinin (n= 30).
Comparison
Tranexamic acid (TXA, n= 30). No intervention (n= 30).
Outcome
The estimated blood volume losses 2 hours and 8 hours postoperatively significantly dropped in the TXA and aprotinin groups compared to no intervention. Rates of postoperative blood transfusion were significantly higher in the no intervention group. Haemoglobin and haematocrit 8 hours postoperatively were lower in the no intervention group than in the TXA or aprotinin treatment groups.
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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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Editor's Choice
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.