Inconclusive evidence for the efficacy of tranexamic acid in reducing transfusions, postoperative infection or hematoma formation after primary shoulder arthroplasty: A meta-analysis with trial sequential analysis
Shoulder & elbow. 2021;13(1):38-50
BACKGROUND Tranexamic acid efficacy on clinically relevant adverse outcomes in patients undergoing shoulder arthroplasty has been contradictory. The aim of this review was to analyze whether tranexamic acid administration could decrease transfusions, infection and hematoma formation in patients undergoing shoulder arthroplasty. METHODS PubMed, EMBASE, and the Cochrane Library were searched up to May 2019 for randomized controlled trials comparing tranexamic acid to placebo in shoulder arthroplasty. Random-effect models were performed to meta-analyze the evidence. Trial sequential analysis was used to calculate and to establish the conclusiveness of the evidence derived from the meta-analysis. RESULTS Four randomized controlled trials comprising 375 patients were included. Meta-analysis showed no effect of tranexamic acid on transfusion rate (RR = 0.48 (adjusted 95% CI 0.05 to 3.85)). The possible effect of tranexamic acid on hematoma formation or infection rates after shoulder arthroplasty is non-estimable with the current evidence. The sample size necessary to reliably determine if tranexamic acid decreases transfusions, infection rates and hematoma formation is not available from the current literature as determined by the trial sequential analysis. DISCUSSION While tranexamic acid has proven its efficacy in decreasing blood loss in shoulder arthroplasty, this meta-analysis of randomized controlled trials clarifies that there is currently no conclusive evidence for a positive effect of tranexamic acid upon transfusion rate, infection rates or hematoma formation in patients undergoing primary shoulder arthroplasty.
Complications of Tranexamic Acid in Orthopedic Lower Limb Surgery: A Meta-Analysis of Randomized Controlled Trials
BioMed research international. 2021;2021:6961540
OBJECTIVE Tranexamic acid (TXA) is increasingly used in orthopedic surgery to reduce blood loss; however, there are concerns about the risk of venous thromboembolic (VTE) complications. The aim of this study was to evaluate TXA safety in patients undergoing lower limb orthopedic surgical procedures. DESIGN A meta-analysis was performed on the PubMed, Web of Science, and Cochrane Library databases in January 2020 using the following string (Tranexamic acid) AND ((knee) OR (hip) OR (ankle) OR (lower limb)) to identify RCTs about TXA use in patients undergoing every kind of lower limb surgical orthopedic procedures, with IV, IA, or oral administration, and compared with a control arm to quantify the VTE complication rates. RESULTS A total of 140 articles documenting 9,067 patients receiving TXA were identified. Specifically, 82 studies focused on TKA, 41 on THA, and 17 on other surgeries, including anterior cruciate ligament reconstruction, intertrochanteric fractures, and meniscectomies. The intravenous TXA administration protocol was studied in 111 articles, the intra-articular in 45, and the oral one in 7 articles. No differences in terms of thromboembolic complications were detected between the TXA and control groups neither in the overall population (2.4% and 2.8%, respectively) nor in any subgroup based on the surgical procedure and TXA administration route. CONCLUSIONS There is an increasing interest in TXA use, which has been recently broadened from the most common joint replacement procedures to the other types of surgeries. Overall, TXA did not increase the risk of VTE complications, regardless of the administration route, thus supporting the safety of using TXA for lower limb orthopedic surgical procedures.
Lower tourniquet pressure does not affect pain nor knee-extension strength in patients after total knee arthroplasty: a randomized controlled trial
Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA. 2021
PURPOSE The use of a tourniquet in total knee replacement has advantages and drawbacks. Some studies suggest that using ischaemia at low pressures could reduce its negative effects. Our objective is to verify whether the use of ischaemia at low pressures (100 mmHg above the systolic blood pressure) produces greater pain and loss of strength than surgery without a tourniquet. METHODS By the means of a prospective randomized clinical trial, patients were assigned to the control group (no tourniquet, NT) or the experimental group (tourniquet, T). The main variables measured were pain (VAS) and isometric muscle strength (preoperatively, 10 days and 3 months after surgery). Secondary variables were haemoglobin at 24 h, transfusion index, need for rescue drugs and days of admission. RESULTS A total of 71 patients (73 prosthesis) were studied. Both groups were homogeneous in terms of age, body mass index, sex ratio, preoperative strength and level of anesthetic risk. We did not find significative differences in any of the main variables (pain and strength) nor in the secondary ones. We could only find differences in the days of admission (2.77 vs. 3.05; p = 0.031). CONCLUSIONS Use of a tourniquet at low pressures (100 mmHg above systolic blood pressure) did not result in an increase in postoperative pain or a decrease in quadriceps extension force within the first 3 months after surgery. LEVEL OF EVIDENCE Level 1-Randomized controlled trial.
Effects of Tourniquet Application on Faster Recovery after Surgery and Ischemia-Reperfusion Post-Total Knee Arthroplasty, Cementation through Closure versus Full-Course and Nontourniquet Group
The journal of knee surgery. 2021
Pneumatic tourniquets are used in total knee arthroplasty (TKA) for surgical field visualization and improved cementation; however, their use is controversial. This study aimed to assess the effects of tourniquet application on faster recovery post-TKA. Our hypothesis was that inflammation and limb function would be similar with different tourniquet applications. A prospective randomized double-blinded trial assessed tourniquets effects on postoperative pain, swelling, and early outcome in TKA. In present study, 50 TKAs were enrolled in each group as follows: full course (FC), cementation through closure (CTC), and no tourniquet (NT), CTC as treatment group while FC and NT as control groups. Topical blood samples of 3 mL from the joint cavity and drainage bags were obtained at special time point. At last, all samples such as tumor necrosis factor-a (TNF-a), C-C motif chemokine ligand 2 (CCL2), pentraxin 3 (PTX3), prostaglandin E2 (PGE2), superoxide dismutase 1 (SOD1), and myoglobin (Mb) were detected by ELISA. Active and passive range of motion (ROM) values, pain score by the visual analog scale (VAS), change of thigh circumference were recorded at special time point as well. In topical blood, the change of inflammatory factors, such as TNF-a, PTX3, CCL2, PGE2, SOD1, and Mb, was lower in CTC and NT groups than in FC group (p < 0.01 and 0.05). Although VAS and ROM were comparable preoperatively in three groups (p > 0.05), the perimeter growth rate was lower, pain scores (VAS) were reduced, and ROM values were improved in CTC and NT groups compared with FC group at T4, T5, and T6 postoperatively (p < 0.01 and 0.05). Improved therapeutic outcome was observed in the CTC group, indicating patients should routinely undergo TKA with cementation through closure tourniquet application.
Use of tranexamic acid does not influence perioperative outcomes in ambulatory foot and ankle surgery-a prospective triple blinded randomized controlled trial
International orthopaedics. 2021
STUDY OBJECTIVE TXA is an antifibrinolytic medication widely used to reduce perioperative blood loss, but it has been seldom used during foot and ankle surgery. Our study evaluates the impact of TXA use on blood loss, post-operative pain, peri-operative opioid consumption, and wound healing in ambulatory outpatient foot and ankle procedures. DESIGN Prospective, triple-blinded, randomized controlled trial. SETTING Peri-operative environment of a major academic health centre in New York City. PATIENTS A total of 100 participants who were scheduled for ambulatory foot and ankle surgery with a single surgeon. INTERVENTIONS Patients receive either 10 mg/kg TXA (TXA group) or 10 ml/kg of normal saline (placebo group) intravenously prior to skin incision. MEASUREMENTS Primary outcome was intra-operative blood loss. Secondary outcomes were peri-operative opioid consumption and wound complications between post-operative days 14 and 21. MAIN RESULTS We found no difference between TXA and placebo groups in terms of intra-operative blood loss, p value 0.71, 95% CI (63.13-19.80). There was no difference between the two groups in terms of post-operative morphine milliequivalents (MME). The incidence of wound complications was 16.3% in the TXA group compared to 15.7% in the placebo group with OR 1.04, p value 0.93, 95% CI (0.32-2.77). No adverse events associated with TXA were reported. CONCLUSIONS The use of TXA during foot and ankle surgery was not associated with any benefits in perioperative outcomes in our outpatient ambulatory surgical population. Considering potential risks, we do not support the routine use of TXA in this surgical model.
Effects of Local Administration of Tranexamic Acid on Reducing Postoperative Blood Loss in Surgeries for Closed, Sanders III-IV Calcaneal Fractures: A Randomized Controlled Study
Indian journal of orthopaedics. 2021;55(Suppl 2):418-425
PURPOSE To investigate whether local administration of tranexamic acid (TXA) is effective in postoperative blood loss reduction in surgeries for Sanders III-IV calcaneal fractures. METHODS Calcaneal fracture patients who were hospitalized in our hospital from August 2014 to April 2018 and underwent open reduction internal fixation (ORIF) via lateral approach with an L-shaped incision were included in the present study. 53 Patients were randomly divided into three groups, groups A (17), B (17) and C (19). Twenty milliliters of 10 mg/ml and 20 mg/ml TXA solution were perfused into the incision of patients in group A and group B, respectively. Twenty milliliters of saline were perfused into the incision of patients in group C as control. The volume of postoperative drainage, postoperative blood test, coagulation test, and wound complications were analyzed to evaluate the effectiveness of local administration of TXA on blood loss reduction. RESULTS The amount of drainage at 24 and 48 h after the procedure was 110 ± 170, 30 ± 10 ml and 130 ± 160, 20 ± 17 ml for patients in group A and group B, respectively. The corresponding numbers for patients in group C were 360 ± 320, 20 ± 10 ml. The difference between group A and group C was statistically significant, so was the difference between group B and group C. No statistically significant difference was found between group A and group B. Postoperative blood test results revealed that the levels of hemoglobin and hematocrit were significantly higher in group A and group B when each compared to that of group C. In contrast, no difference was found between group A and group B. No significant difference was found between each experimental group and the control group in terms of platelet counts, prothrombin time (P.T.), activated partial prothrombin time (APTT), and wound complications. CONCLUSION Local administration of TXA is effective in the reduction of postoperative blood loss in surgeries for Sanders III-IV types of calcaneal fractures without notably associated side effects.
Oral tranexamic acid for an additional 24 hours postoperatively versus a single preoperative intravenous dose for reducing blood loss in total knee arthroplasty: results of a randomized controlled trial (TRAC-24)
The bone & joint journal. 2021;103-b(10):1595-1603
AIMS: In total knee arthroplasty (TKA), blood loss continues internally after surgery is complete. Typically, the total loss over 48 postoperative hours can be around 1,300 ml, with most occurring within the first 24 hours. We hypothesize that the full potential of tranexamic acid (TXA) to decrease TKA blood loss has not yet been harnessed because it is rarely used beyond the intraoperative period, and is usually withheld from 'high-risk' patients with a history of thromboembolic, cardiovascular, or cerebrovascular disease, a patient group who would benefit greatly from a reduced blood loss. METHODS TRAC-24 was a prospective, phase IV, single-centre, open label, parallel group, randomized controlled trial on patients undergoing TKA, including those labelled as high-risk. The primary outcome was indirect calculated blood loss (IBL) at 48 hours. Group 1 received 1 g intravenous (IV) TXA at the time of surgery and an additional 24-hour postoperative oral regime of four 1 g doses, while Group 2 only received the intraoperative dose and Group 3 did not receive any TXA. RESULTS Between July 2016 and July 2018, 552 patients were randomized to either Group 1 (n = 241), Group 2 (n = 243), or Group 3 (n = 68), and 551 were included in the final analysis. The blood loss did differ significantly between the two intervention groups (733.5 ml (SD 384.0) for Group 1 and 859.2 ml (SD 363.6 ml) for Group 2; mean difference -125.8 ml (95% confidence interval -194.0 to -57.5; p < 0.001). No differences in mortality or thromboembolic events were observed in any group. CONCLUSION These data support the hypothesis that in TKA, a TXA regime consisting of IV 1 g perioperatively and four oral 1 g doses over 24 hours postoperatively significantly reduces blood loss beyond that achieved with a single IV 1 g perioperative dose alone. TXA appears safe in patients with history of thromboembolic, cardiovascular, and cerebrovascular disease. Cite this article: Bone Joint J 2021;103-B(10):1595-1603.
Efficacy and Systemic Absorption of Peri-articular Versus Intra-articular Administration of Tranexamic Acid in Total Knee Arthroplasty: A Prospective Randomized Controlled Trial
Arthroplasty today. 2021;11:1-5
BACKGROUND Tranexamic acid (TXA) is widely accepted as an effective method for reducing blood loss after total knee arthroplasty (TKA). As different routes of local TXA administration have been proposed to minimize systemic complications, we aimed to investigate the effectiveness and systemic absorption of peri-articular (PA) and intra-articular (IA) administration of TXA after primary TKA. METHODS In a randomized controlled trial of patients scheduled for unilateral primary TKA, 108 were assigned to receive PA-TXA (15 mg/kg), IA-TXA (2 g), or no TXA injection. We assessed total blood loss, blood transfusion rate, and hemoglobin level changes 48 hours after surgery. Postoperative serum TXA levels, complications, and clinical symptoms of venous thromboembolism events were also evaluated. RESULTS Total blood loss, hemoglobin level decreases, and blood transfusion rates in both TXA groups were significantly lower than those in the control group (P < .05), without significant differences between PA and IA groups 48 hours after surgery. Serum TXA levels in the IA group were significantly higher than those in the PA cohort at 2 hours (28.2 mg/L vs 15.6 mg/L, P < .01) and 24 hours (4.4 mg/L vs 1.7 mg/L, P < .01) postoperatively. No wound complications were found in both TXA groups, but 14% of the control group developed subcutaneous ecchymoses. No evidence of venous thromboembolism events was reported. CONCLUSIONS PA-TXA is an excellent alternative route of local TXA injection to decrease postoperative blood loss after TKA. PA-TXA demonstrated lower levels of postoperative serum TXA, which may be beneficial for high-risk patients.
Effect of Different Tourniquet Pressure on Postoperative Pain and Complications After Total Knee Arthroplasty: A Prospective, Randomized Controlled Trial
The Journal of arthroplasty. 2021
BACKGROUND Tourniquet pressure inflation is commonly selected between 100 and 150 mm Hg above the systolic blood pressure (SBP). Given the lack of evidence to support a given inflation pressure, our study aimed to ascertain the lowest tourniquet pressure that facilitated total knee arthroplasty (TKA) and resulted in the least postoperative pain and complications. METHODS In a double-blind, randomized controlled trial of patients scheduled for unilateral primary TKA, 150 were assigned to use tourniquet pressures of SBP + 75 mm Hg (group I), SBP + 100 mm Hg (group II), and SBP + 150 mm Hg (group III). The quality of the bloodless field, total blood loss, and limb swelling were determined perioperatively. Clinical outcomes were evaluated by visual analog scale for pain at thigh and surgical site, serum creatinine phosphokinase levels, wound complications, range of motion, and Knee Society Score. RESULTS Visual analog scale for pain at thigh and surgical site were lowest in group I (P < .01) and highest in group III (P < .01). However, the quality of bloodless field at the tibial cutting surface was significantly better in group III compared to group I/II but not at the femoral cutting surface. The total blood loss and limb swelling showed no difference among 3 groups. Postoperative serum creatinine phosphokinase levels at 24 and 48 hours and wound complications in group III were significantly higher than group I (P < .01) and group II (P < .01). Nevertheless, postoperative knee range of motion and Knee Society Score were not significantly different among 3 groups. CONCLUSION Post TKA, the lowest tourniquet pressure was associated with significantly less postoperative tourniquet and surgical site pain, muscle damage, and wound complications.
Tourniquet Use in Arthroscopic ACL Reconstruction: A Blinded Randomized Trial
Indian journal of orthopaedics. 2021;55(2):384-391
INTRODUCTION Despite knowing, that tourniquet induces ischemia and soft tissue damage surgeons still use it. The purpose of this study is to compare post operative pain and quadriceps function in patients undergoing arthroscopy assisted ACL reconstruction with tourniquet and without tourniquet. METHODS A blinded randomized prospective trial conducted at Orthopaedic department of a tertiary institute in India from Feb 2019 to June 2019. 45 patients undergoing Arthroscopic ACL reconstruction aged between 18 and 60 years were recruited in the study according to selection criteria. Patients were distributed in 2 groups randomly, namely, tourniquet and non-tourniquet. Preoperatively serum CPK measurement and thigh girth measurement was done. Following standard arthroscopic procedure VAS score monitoring for pain was done for 5 days. Serum CPK levels were performed on postoperative day 1. Thigh girth was measured on postoperative day 21. RESULT Pain was significantly high in patients in whom tourniquet was used. VAS scores were significantly high in tourniquet group. Tourniquet group patients required more amount of additional analgesics in postoperative period (p < 0.001). Serum CPK levels were comparable preoperatively while significantly high postoperatively in tourniquet group (p < 0.001). Difference in mean of thigh girth was significant between the groups (p < 0.001) and there is difficulty experienced by patients in performing straight leg raise test after tourniquet use (p = 0.002). CONCLUSION Tourniquet use is associated with increased pain, analgesic requirement, damage to muscles and compromises muscle function in early postoperative period. This can not only lead to increased patient discomfort but also difficult initial rehabilitation. Arthroscopic procedures can be uneventfully performed without the use of a tourniquet, and alternative methods should be looked upon and emphasized.