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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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Comparison of the effect of open-box versus closed-box prostheses on blood loss following total knee arthroplasty: a meta-analysis
Elhalag, R. H., Dean, Y. E., Hamdy, A., Hadhoud, A. M., Chébl, P., Shah, J., Gawad, M., Motawea, K. R.
Annals of medicine and surgery (2012). 2024;86(2):1021-1028
Abstract
PURPOSE Postoperative blood loss is a common complication following total knee arthroplasty (TKA). The authors aimed to analyze the significance of open versus closed-box prostheses in reducing blood loss after TKA. METHODS PubMed, Cochrane, Scopus, and Web of Science were searched. Observational studies and clinical trials comparing the effect of open-box versus closed-box prostheses on blood loss following TKA were included. The primary outcome was total blood loss following TKA. Secondary outcomes included average transfused units and total operation time. Continuous data were represented as mean difference (MD) and CI, while dichotomous data were presented as odds ratio (OR) and CI. RevMan software version 5.4 was used to conduct the analysis. RESULTS Four studies with a total number of 687 patients were included. The pooled analysis showed a statistically significant association between closed-box and decreased total blood loss following TKA compared with open-box (MD=173.19, 95% CI=88.77-257.61, P value <0.0001). Similar findings were reported in unilateral TKA (MD=190.63, 95% CI=70.91-310.35, P value=0.002), and bilateral TKA (MD=160.79, 95% CI=61.70-359.86, P value=0.001). There was no significant difference between open and closed-box regarding average transfused units (MD=0.02, 95% CI=-0.07-0.11, P value=0.68), blood transfusion rate (OR=1.38, 95% CI=0.85-2.26, P value=0.20), length of stay (MD=0.06, 95% CI=-0.27 to 0.38, P value=0.74), and total operation time (MD=1.08, 95% CI=-4.62 to 6.79, P value=0.71). CONCLUSION Closed-box reduces the total blood loss following unilateral and bilateral TKA. More studies are warranted to explore the benefits of Closed-box in patients with high bleeding susceptibility.
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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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Tranexamic Acid for Rotator Cuff Repair: A Systematic Review and Meta-analysis of Randomized Controlled Trials
Hurley, E. T., Rodriguez, K., Karavan, M. P., Levin, J. M., Helmkamp, J., Anakwenze, O., Alaia, M. J., Klifto, C. S.
The American journal of sports medicine. 2024;:3635465231216336
Abstract
BACKGROUND Several randomized controlled trials (RCTs) have been conducted to assess the use of tranexamic acid (TXA) in the setting of arthroscopic rotator cuff repair (ARCR). However, these studies have shown mixed results, with some showing improved intraoperative visualization, subsequent operative times, and pain levels, and others finding no difference. PURPOSE To perform a systematic review of the RCTs in the literature to evaluate the use of TXA on ARCR. STUDY DESIGN Meta-analysis; Level of evidence, 1. METHODS Two independent reviewers performed the literature search based on the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, with a third author resolving any discrepancies. RCTs comparing TXA with a control in ARCR were included. Visualization, postoperative pain, operative time, pump pressures, and shoulder swelling were evaluated. A P value < .05 was deemed statistically significant. RESULTS Six RCTs with 450 patients were included in this review. Overall, 5 studies evaluated intraoperative visualization, with 3 studies finding a significant difference in favor of TXA. With TXA, patients had a lower mean postoperative visual analog scale (VAS) score of 3.3, and with the control, patients had a mean VAS score of 4.1, which was statistically significant (P = .001). With TXA, the mean weighted operation time was 79.3 minutes, and with the control, the mean operation time was 88.8 minutes, which was statistically significant (P = .001). No study found any difference in intraoperative pump pressures or swelling. CONCLUSION TXA improved visualization, operative time, and subsequent postoperative pain levels in patients undergoing ARCR.
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A systematic review of tourniquet use in paediatric orthopaedic surgery: can we extrapolate from adult guidelines?
Pintar, V., Brookes, C., Trompeter, A., Bridgens, A., Hing, C., Gelfer, Y.
EFORT open reviews. 2024;9(1):80-91
Abstract
PURPOSE Tourniquets are commonly used intraoperatively in orthopaedic surgery to control bleeding and improve visibility in the surgical field. Recent evidence has thrown into question the routine use of tourniquets in the adult population resulting in a British Orthopaedic Association standard for intraoperative use. This systematic review evaluates the evidence on the practice, benefits, and risks of the intraoperative use of tourniquets for trauma and elective orthopaedic surgery in the paediatric population. METHODS A prospectively registered systematic review was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines (PROSPERO CRD42022359048). A search of MEDLINE, Embase, the Cochrane Library and a Grey literature search was performed from their earliest record to 23 March 2023. Studies reporting tourniquet data in paediatric patients undergoing orthopaedic surgery were included. Data extracted included demographics, involved limb, trauma versus elective use, tourniquet use as primary or secondary measure, and tourniquet parameters and complications. RESULTS Thirty-nine studies were included. Tourniquet practices and information reporting varied considerably. Tourniquets were used uneventfully in the majority of patients with no specific benefits reported. Several physiological and biochemical changes as well as complications including nerve injury, compartment syndrome, skin burns, thrombosis, post-operative limb swelling, and pain were reported. CONCLUSIONS Tourniquets are routinely used in both trauma and elective paediatric orthopaedic surgery with no high-quality research affirming benefits. Severe complications associated with their use are rare but do occur. High-quality studies addressing their benefits, the exact indication in children, and the safest way to use them in this population are necessary.
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The effect of tranexamic acid and adrenaline on visual clarity during arthroscopic shoulder surgery: A meta-analysis of RCTs
Malik, S. S., Tahir, M., Jordan, R. W., Kwapisz, A., Alessandro, P., Donald, P. M., Woodmass, J.
Orthopaedics & traumatology, surgery & research : OTSR. 2024;:103844
Abstract
INTRODUCTION Visual clarity in in arthroscopic rotator cuff repair is essential to reduce the operative time and for efficiency of repair. Tranexamic acid (TXA) in open shoulder surgery has been shown to reduce blood loss but its use in shoulder arthroscopy for rotator cuff repair for improved clarity is not understood. The purpose of this SR is to determine the effect of TXA and epinephrine on visual clarity in shoulder arthroscopy for rotator cuff repair. HYPOTHESIS We hypothesise that visual clarity should improve in those that have TXA compared to those who do not receive TXA. METHODS A review of the online databases MEDLINE and Embase was conducted on 8th October 2022 according to PRISMA guidelines. The review was registered prospectively in the PROSPERO database. Randomised clinical trials reporting visual clarity and/or, operative time, volume of irrigation fluid used and mean arterial pressure were included. The studies were appraised using the CONSORT tool. RESULTS Seven studies met eligible criteria, all of which were double blinded RCTs. Five studies reported no difference in visual clarity between TXA vs saline, while two reported a significant improvement with TXA. Pooling of data showed that visual clarity was significantly better in the TXA group vs saline, on a standardised 10-point Likert scale (mean difference 0.73 points, p= 0.03). However, the use of adrenaline was reported in two studies and its administration offered significantly better visual clarity than TXA (mean difference 0.9 points, p=0.02). There was no significant difference with TXA use in MAP (mean difference 1.2mmHg, p= 0.14), operative time (mean difference 6.8 minutes, p= 0.11), irrigation volume used (mean difference 0.2L, p=0.88), or post-operative pain (mean difference 3.89 on a 0-100 VAS, p= 0.34). CONCLUSION The use of TXA in shoulder arthroscopy has shown to have significantly improved visual clarity in comparison to saline irrigation alone. This may not necessarily result in a significant clinical difference and may not translate to significantly less operative time or post-operative pain score. Furthermore, adrenaline use alone offers significantly better clarity than TXA. There may not be an added benefit to give both, but this area requires further research. LEVEL OF EVIDENCE II; Systematic review.
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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.