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Oral as compared to intravenous tranexamic acid to limit peri-operative blood loss associated with primary total hip arthroplasty: A randomised noninferiority trial
Piette, N., Beck, F., Carella, M., Hans, G., Maesen, D., Kurth, W., Lecoq, J. P., Bonhomme, V. L.
European journal of anaesthesiology. 2024
Abstract
BACKGROUND Oral as compared to intravenous tranexamic acid (TXA) is an attractive option, in terms of cost and safety, to reduce blood loss and transfusion in total hip arthroplasty. Exclusion criteria applied in the most recent randomised trials may have limited the generalisability of oral tranexamic acid in this indication. Larger and more inclusive studies are needed to definitively establish oral administration as a credible alternative to intravenous administration. OBJECTIVES To assess the noninferiority of oral to intravenous TXA at reducing intra-operative and postoperative total blood loss (TBL) in primary posterolateral approached total hip arthroplasty (PLTHA). DESIGN Noninferiority, single centre, randomised, double-blind controlled study. SETTING Patients scheduled for primary PLTHA. Data acquisition occurred between May 2021 and November 2022 at the University Hospital of Liège, Belgium. PATIENTS Two hundred and twenty-eight patients, randomised in a 1 : 1 ratio from a computer-generated list, completed the trial. INTERVENTIONS Administration of 2 g of oral TXA 2 h before total hip arthroplasty and 4 h after incision (Group oral) was compared to the intravenous administration of 1 g of TXA 30 min before surgery and 4 h after incision (Group i.v.). MAIN OUTCOME MEASURES TBL (measured intra-operative and drainage blood loss up to 48 h after surgery, primary outcome), decrease in haemoglobin concentration, D-Dimer at day 1 and day 3, transfusion rate (secondary outcomes). RESULTS Analyses were performed on 108 out of 114 participants (Group i.v.) and 104 out of 114 participants (Group oral). Group oral was noninferior to Group i.v. with regard to TBL, with a difference between medians (95% CI) of 35 ml (-103.77 to 33.77) within the noninferiority margins. Median [IQR] of estimated TBL was 480 ml [350 to 565] and 445 ml [323 to 558], respectively. No significant interaction between group and time was observed regarding the evolution of TBL and haemoglobin over time. CONCLUSIONS TXA as an oral premedication before PLTHA is noninferior to its intravenous administration regarding peri-operative TBL. TRIAL REGISTRATION European Clinical Trial Register under EudraCT-number 2020-004167-29 (https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-004167-29/BE).
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Impact of intraosseous regional administration of tranexamic acid in total knee arthroplasty on perioperative blood loss: a protocol for a randomised controlled trial
Wei, Z., Yu, M., Xu, Y., Weng, X., Feng, B.
BMJ open. 2024;14(2):e077393
Abstract
INTRODUCTION Total knee arthroplasty (TKA) is a common surgical intervention to treat joint diseases. However, TKA is associated with significant blood loss. Tranexamic acid (TXA) has been used to reduce perioperative bleeding and postoperative blood transfusion. This study aims to explore the effectiveness and safety of intraosseous regional administration (IORA) of TXA in TKA and compare differences in perioperative blood loss between IORA of TXA, intravenous infusion of TXA, and combined IORA and intravenous infusion of TXA. METHODS AND ANALYSIS This randomised controlled trial will enrol 105 patients with osteoarthritis who meet the inclusion criteria for unilateral TKA. Patients were randomly divided into three groups using the random number table method. Group A received 1.0 g of TXA via IORA, group B received 1.0 g of TXA via intravenous infusion 15 min prior to the tourniquet release, and group C received both IORA of 1.0 g of TXA and intravenous infusion of 1.0 g of TXA. The primary outcome measure is perioperative total blood loss. Secondary outcomes include bleeding events, venous thromboembolism events, inflammation reactions, other complications and knee function assessments. ETHICS AND DISSEMINATION This study has been approved by the Ethics Committee of Peking Union Medical College Hospital and registered in the Chinese Clinical Trial Registry. Informed consent will be obtained from all the patients before enrolment. The trial will be conducted in accordance with the principles of the Declaration of Helsinki and the International Conference on Harmonization Good Clinical Practice guidelines. The results of this study will be disseminated through peer-reviewed publications, conference presentations and social media platforms. The findings will provide valuable insights into the use of IORA of TXA in TKA and may lead to the development of new strategies for perioperative blood management in joint replacement surgery. TRIAL REGISTRATION NUMBER The Ethics Committee of Peking Union Medical College Hospital (approval number: K2371); Chinese Clinical Trial Registry (trial registration number: ChiCTR2200066293).
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Application of Tranexamic Acid in Shoulder Arthroscopic Surgery: A Randomised Controlled Trial
Wang, T. C., Guo, J. L., Tian, Q. P., Deng, H. P., Yin, B., Xiao, Z., Lu, B.
Chinese medical sciences journal = Chung-kuo i hsueh k'o hsueh tsa chih. 2024
Abstract
Objective To explore the optimal administration route of tranexamic acid in optimal arthroscopic surgery. Methods Patients undergoing arthroscopic rotator cuff repair were randomly divided into 4 groups: control group (without TXA treatment), intravenous group (TXA was intravenously administered 10 minutes before surgery), irrigation group (TXA was added to the irrigation fluid during subacromial decompression and acromioplasty), and intravenous plus irrigation group (TXA was applied both intravenously and via intra-articular irrigation). The primary outcome was visual clarity assessed with visual analog scale (VAS) score, and the secondary outcomes included irrigation fluid consumption and time to subacromial decompression and acromioplasty procedure. Result The final analysis included 134 patients, including 33 in the control group, 35 in the intravenous group, 32 in the irrigation group, and 34 in the intravenous and irrigation group. The VAS scores of the intravenous, irrigation, and intravenous plus irrigation groups were 2.70 (2.50, 2.86) (Z = -3.677, P = 0.001), 2.67 (2.50, 2.77) (Z = -3.058, P < 0.001), and 2.91 (2.75, 3.00) (Z = -6.634, P < 0.001), respectively, significantly higher than that of the control group [2.44 (2.37, 2.53)]. Moreover, the control group consumed more irrigation fluid than intravenous group, irrigation group, and intravenous plus irrigation group (all P < 0.05). The intravenous plus irrigation group consumed less irrigation fluid than either the intravenous group or the irrigation group (both P < 0.001). There was no difference in subacromial decompression and acromioplasty operative time among all the 4 groups. Conclusion TXA applied both topically and systematically can improve intraoperative visual clarity, and the combined application is more effective.
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High dose of tranexamic acid infusion in primary total knee arthroplasty: A randomized multicenter clinical trail
Xie, J., Huang, Q., Huang, Z., Wang, F., Liu, J., Tian, H., Huang, W., Pei, F.
Chinese medical journal. 2024
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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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Comparison of Combined Intraarticular and Intravenous Administration of Tranexamic Acid with Intraarticular and Intravenous Alone in Patients Undergoing Total Knee Arthroplasty without Drainage Catheter: A Clinical Trial Study
Bagheri, N., Amini, M. A., Pourahmad, A., Vosoughi, F., Moharrami, A., Mortazavi, S. J.
The archives of bone and joint surgery. 2023;11(9):570-576
Abstract
OBJECTIVES We aimed to assess the most effective route for Tranexamic acid (TXA) administration among Intraarticular (IA), Intravenous (IV), and combined IA/IV for Total Knee Arthroplasty (TKA) surgeries. METHODS A double-blinded clinical trial was run on 147 TKA candidates. Blood loss and hemoglobin (Hb) drop were evaluated using the Gross and Nadler formula in three matched case groups administered TXA during the TKA through IV, IA, or combined IA/IV route. Tourniquet was used on all operations for controlling intraoperative blood loss. No drainage catheter was used for the cases. RESULTS The combined group showed an average blood loss of 630±252 ml, which was significantly lower than that in the IV group (878±268 ml, P<0.01) and the IA group (774±288 ml, P=0.03). Furthermore, the mean Hb and hematocrit drop were significantly lower in the combined group, compared to the other two groups, 48 and 72 h postoperatively (P<0.05). CONCLUSION The combined IA/IV route had a 28% and 19% reduction of blood loss, compared to the IV or IA methods, respectively. Therefore, using TXA via the combined IA/IV route may be more effective for reducing perioperative blood loss following TKA surgery using a tourniquet without drain placement.
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Medullary cavity application of tranexamic acid to reduce blood loss in tibial intramedullary nailing procedures-a randomized controlled trial
Xiao C, Gao Z, Yu W, Yao K, Cao Y, Long N, Zhang S, Jiang Y
International orthopaedics. 2023
Abstract
PURPOSE Studies have shown an average postoperative hidden blood loss (HBL) of 473.29 ml and an average Hb loss of 16.71 g/l after intramedullary nailing. Reducing HBL has become a primary consideration for orthopaedic surgeons. METHODS Patients with only tibial stem fractures who visited the study clinic between December 2019 and February 2022 were randomized into two groups using a computer-generated form. Two grams of tranexamic acid (TXA) (20 ml) or 20 ml of saline was injected into the medullary cavity before implantation of the intramedullary nail. On the morning of the surgery, as well as on days one, three and five after surgery, routine blood tests and analyses of CRP and interleukin-6 were completed. The primary outcomes were total blood loss (TBL), HBL, and blood transfusion, in which the TBL and HBL were calculated according to the Gross equation and the Nadler equation. Three months after surgery, the incidence of wound complications and thrombotic events, including deep vein thrombosis and pulmonary embolism, was recorded. RESULTS Ninety-seven patients (47 in the TXA group and 50 in the NS group) were analyzed; the TBL (252.10 ± 10.05 ml) and HBL (202.67 ± 11.86 ml) in the TXA group were significantly lower than the TBL (417.03 ± 14.60 ml) and HBL (373.85 ± 23.70 ml) in the NS group (p < 0.05). At the three month postoperative follow-up, two patients (4.25%) in the TXA group and three patients (6.00%) in the NS group developed deep vein thrombosis, with no significant difference in the incidence of thrombotic complications (p = 0.944). No postoperative deaths or wound complications occurred in either group. CONCLUSIONS The combination of intravenous and topical TXA reduces blood loss after intramedullary nailing of tibial fractures without increasing the incidence of thrombotic events.
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Tranexamic acid has no effect on postoperative pain control after arthroscopic rotator cuff repair: A prospective, double-blind, randomized controlled trial
Takahashi, R., Kajita, Y., Iwahori, Y., Harada, Y.
Asia-Pacific journal of sports medicine, arthroscopy, rehabilitation and technology. 2023;33:32-35
Abstract
BACKGROUND The purpose of this study was to compare the efficacies of tranexamic acid (TXA) versus placebo after arthroscopic rotator cuff repair (ARCR). METHODS This prospective, double-blind, and randomized study was conducted in 70 patients who underwent ARCR from 2021 to 2022 at our hospital. Thirty-four shoulders were randomly assigned to the TXA group, and 36 to the control group; TXA (10 mL) and normal saline (10 mL) were administered locally after surgery and in the control group, respectively. We evaluated visual analog scale pain scores at rest, during activity, and at night and the circumference and diameter of the shoulder joint in both groups preoperatively and at 1, 2, and 3 days, and 1 week after the surgery. We compared and analyzed the results between the groups. Statistical significance was set at a p-value of <0.05. RESULTS There was no significant difference in the visual analog scale scores at rest, during activity, and at night between the groups (p > 0.05). The circumference and diameter of the shoulder joint were not also significantly different between both groups (p > 0.05). CONCLUSION Local TXA administration in patients who undergo ARCR does not significantly impact postoperative pain levels and the circumference and diameter of the shoulder joint.
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Tranexamic acid administration for arthroscopic rotator cuff repair: A prospective, double-blind, randomized controlled trial
Takahashi, R., Kajita, Y., Iwahori, Y., Harada, Y.
Journal of Orthopaedic Science : Official Journal of the Japanese Orthopaedic Association. 2023;28(2):328-332
Abstract
BACKGROUND The purpose of this study was to compare the efficacy of tranexamic acid versus placebo after arthroscopic rotator cuff repair. METHODS This prospective, double-blind, and randomized study involved 66 patients who consecutively underwent arthroscopic rotator cuff repair from 2020 to 2021 at our hospital. Thirty-three shoulders each were randomly assigned to the tranexamic acid and control groups. In the former group, 1000 mg of tranexamic acid (20 mL) was administered intravenously 10 min before surgery and the same volume of normal saline (20 mL) was administered intravenously in the control group. We evaluated visual clarity; visual analog scale pain scores at rest, during activity, and at night; the circumference and diameter of the shoulder joint in the groups before and after the surgery at 1, 2, and 3 days, and 1 week; estimated perioperative blood loss; and operative time. Visual clarity was rated using a numeric rating scale from grade 1 (poor) to grade 3 (clear) every 15 min throughout the surgery. We compared and analyzed the results between the groups. Statistical significance was set at a p-value of <0.05. RESULTS Visual clarity was found to be significantly better in the tranexamic acid group, with a greater percentage of grade 3 visual clarity (75.6 ± 11.2% vs 68.1 ± 13.4%, p = 0.045). The visual analog scale scores at rest and at night in the control group were significantly lower than those in the tranexamic acid group for 1 week postoperatively (13.8 ± 14.8 vs 5 ± 9.3, p = 0.008, 36.1 ± 23.3 vs 19.3 ± 24, p = 0.012). The circumference and diameter of the shoulder joint, estimated perioperative blood loss, and operative time were not significantly different between the two groups. CONCLUSION Intravenous administration of tranexamic acid is an alternative way to improve visual clarity in arthroscopic rotator cuff repair; however, there are no other significant differences compared to the administration of placebo.
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Intravenous Tranexamic Acid Improves Visual Clarity During Synovectomy in Patients Undergoing Arthroscopic Rotator Cuff Repair: A Double-Blind, Randomized Controlled Study
Shin, H. J., You, H. S., Lee, K., Je, L. G., Kim, S. G., Yang, K. S., Jeong, W. K.
Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association. 2023
Abstract
PURPOSE To assess the effects of intravenous tranexamic acid (TXA) on visual clarity at various surgical stages and the correlation between severity of synovitis and bursitis and visual clarity in patients undergoing arthroscopic shoulder surgery under an interscalene brachial plexus block. METHODS This double-blind, randomized controlled study included patients undergoing arthroscopic rotator cuff repair. The TXA group was injected 1000 mg of TXA intravenously, and the control group was administered the same volume in normal saline 10 min preoperatively. Visual clarity was rated according to a three-grade visual clarity scoring system from grade 1 (clear) to grade 3 (poor) at four surgical stages (I, intra-articular soft tissue procedure including synovectomy; II, acromioplasty; III, bursectomy; and IV, greater tuberoplasty). The primary outcome was arthroscopic visual clarity. The secondary outcomes were medications administered for hemodynamic stability, length of hospital stay, and thromboembolic events. RESULTS Altogether, 63 patients were included in the study and they were divided into the TXA group comprising 32 patients and the control group comprising 31 patients. The TXA group showed significantly better visual clarity than the control group (1(1-2) vs 2(1-2), p=0.027) during stage I, but not during stages II-IV. Spearman correlation analysis revealed a significant correlation between synovitis and visual clarity grade during synovectomy (correlation coefficient, 0.393; p=0.001), but not between bursitis and visual clarity grade during bursectomy. Deep vein thrombosis and pulmonary embolism did not occur in either group. CONCLUSIONS Intravenous TXA can improve visual clarity during intra-articular soft tissue procedures, including synovectomy. However, it does not have a significant effect during acromioplasty, bursectomy, and greater tuberoplasty. TXA can be used to improve visual clarity in patients with suspected severe synovitis. LEVEL OF EVIDENCE Level I, randomized controlled trial.