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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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Comparison of Bleeding during Trochanteric Fracture fixation with Mini-Invasive or Conventional Side Plate Fixation: A Randomized Controlled Trial
Besnard, M., Léger, J., Babusiaux, D., Marty, F., Ropars, M., Rosset, P., Nail, L. L.
Orthopaedics & traumatology, surgery & research : OTSR. 2023;:103661
Abstract
BACKGROUND Trochanteric fractures are a public health issue due to the aging of the population. Treatment aims to reduce their related morbidity and mortality and to allow an early return to independence. Post-operative anemia is associated with poorer functional recovery and an increased mortality rate. The aim of this study was to assess whether minimally invasive side plate fixation (Minimal Invasive Screw System, MISS™) resulted in reduced perioperative bleeding compared with conventional fixation (Pertrochanteric Hip Screw, PHS™). HYPOTHESIS We hypothesized that minimally invasive side plate fixation (MISS) would result in reduced perioperative bleeding compared with conventional fixation (PHS). PATIENTS AND METHODS We conducted an open randomized controlled trial with blinded assessment of the primary outcome. Inclusion criteria were patients aged over 65 years with isolated reducible trochanteric fracture. The 2 surgical implants were of the same shape, the only difference between them being the locking mode of the femoral neck screw on the plate of the MISS device, allowing a percutaneous approach. Primary outcome was perioperative bleeding evaluated with Mercuriali's formula. Secondary outcomes included operating time, scar length, length of hospital stay, radiological criteria such as quality of fracture reduction, implant positioning and bone healing, and complications and functional recovery compared between the 2 groups. RESULTS One hundred eight patients met the inclusion criteria and were randomized to receive either PHS (n = 54) or MISS (n = 54). Osteosynthesis with MISS significatively reduced perioperative bleeding (median 243 ml, interquartile range [152-410] vs 334 ml [247-430] with PHS (p = 0.0299)), operating time (65 min [57-73] vs 79 min [66-89] (p = 0.0002)) and scar length after 45 days (7 cm [5-8] vs 14 cm [12-15] (p < 0.0001)). There was no statistically significant difference between groups in postoperative complications, revision surgery or serious adverse events. CONCLUSION Compared with PHS, MISS reduced operating time, perioperative bleeding and scar length with no observed functional difference. LEVEL OF EVIDENCE I.
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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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The Impact of Tourniquet Usage on TKA Outcome: A Single-Center Prospective Trial
Dragosloveanu S, Dragosloveanu C, Petre M, Gherghe ME, Cotor DC
Medicina (Kaunas, Lithuania). 2023;59(5)
Abstract
Background and Objectives: Total knee arthroplasties (TKAs) are the most effective surgical treatment for end-stage knee osteoarthritis. The tourniquet is used to reduce intraoperative blood loss, improving surgical field visualization. There is much controversy regarding the effectiveness and safety of using a tourniquet during total knee arthroplasties. The purpose of this prospective study is to determine the effect of tourniquet usage during TKAs on early functional outcomes and pain in our center. Materials and Methods: We conducted a randomized controlled trial of patients following a primary total knee replacement between October 2020 and August 2021. We recorded presurgical data, which included age, sex and knee range of motion. Intraoperatively, we measured the amount of blood aspiration and the surgical room time. After the surgery, we measured the amount of blood aspirated through the drains and the hemoglobin. We measured flexion, extension, Visual Analogue Scale (VAS) scores, and Western Ontario and McMaster Universities Arthritis Index (WOMAC score) scores for the functional evaluation. Results: We included 96 patients in the T group and 94 in the NT group, respectively, who remained until the last follow-up. Regarding blood loss, the NT group demonstrated significantly lower levels: 245 ± 97.8 mL intraoperative and 324.8 ± 151.65 mL postoperative, compared to the T group, where we recorded 276 ± 109.2 mL during the surgical procedures and 353.44 ± 101.55 mL after the surgery, (p < 0.05). We also recorded significantly shorter operative room time for the NT group, (p < 0.05). During the follow-up, we noticed postoperative improvements but without significant differences between the groups. Conclusions: We found a significant decrease in bleeding after no tourniquet usage during total knee replacements and shorter operative times. On the other hand, the knee function demonstrated no significant differences between the groups. Further studies may be required in order to assess complications.
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Intravenous iron and erythropoietin therapy for postoperative anemia among orthopedic surgery patients
Chen, H., Yu, J., Wei, Q., Zhang, Y., Ouyang, X., Wang, S.
Journal of orthopaedic surgery and research. 2023;18(1):510
Abstract
BACKGROUND Postoperative anemia is a risk factor for adverse surgical outcomes. Our study aimed to assess the role of intravenous iron and erythropoietin therapy for the rapid correction of anemia following orthopedic surgery. METHODS Patients undergoing elective orthopedic surgery were prospectively enrolled and randomly divided into three groups: Control (placebo), Group 1 (IV iron monotherapy), and Group 2 [combined IV iron and recombinant human erythropoietin (rHuEPO) therapy]. Blood tests were performed preoperative (baseline) and on postoperative days (PODs) 1, 3, and 7. RESULTS All groups demonstrated significantly lower hemoglobin (Hb) concentrations compared to baseline, with no significant inter-group differences in postoperative Hb concentrations (p > 0.05). Serum erythropoietin, ferritin, and vitamin B(12) levels, and reticulocyte count increased beyond normal ranges in all groups. Significantly lower serum iron levels were observed postoperatively in all groups (p < 0.05). No significant inter-group differences in hepcidin level were observed (p > 0.05). CONCLUSION Postoperative treatment with combined intravenous iron and rHuEPO was ineffective in correcting postoperative anemia among orthopedic surgery patients, besides achieving higher reticulocyte counts in the first week of surgery. No improvement in mobilization of storage iron was achieved with rHuEPO. We further suggest against vitamin B(12) administration during the early postoperative period.
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Comparison of the effects of different blood conservation techniques in elderly patients undergoing total hip arthroplasty
Cai, Y., He, X., Cheng, Q.
African health sciences. 2023;23(3):514-520
Abstract
BACKGROUND To probe into the influences of different blood conservation techniques on the postoperative coagulation function and prognosis of elderly patients receiving Total Hip Arthroplasty (THA). METHODOLOGY A total of 60 patients were randomly divided into Autologous Blood Transfusion (ABT) group (n=30) and ANH group (n=30). For patients in the ABT group, an autologous blood recovery machine was used to recover, wash and filter the surgical field blood. For those in the Acute Isovolumic Hemodilution (ANH) group, blood was collected preoperatively from the central vein and stored in a citrate anticoagulant blood storage bag, while the same amount of hydroxyethyl starch was injected into the peripheral vein to dilute the blood. After Mai bleeding steps of the operation were completed, the autologous blood of patients was transfused back in both groups. The clinical indicators of patients in each group were observed. RESULTS 48 h after operation, the ANH group obtained a higher level of hemoglobin (Hb), shorter Activated Partial Thromboplastin Time (APTT), and a lower expression rate of platelet activating factor CD62P than the ABT group. CONCLUSION The ANH group exhibits higher content of hemoglobin and fewer platelet (Plt)activating factors produced than the ABT group, while no significant difference in the shortened length of hospital stays is found.