Randomized, placebo-controlled, double-blind clinical trial to evaluate efficacy and safety of topical tranexamic acid in saving blood loss in patients undergoing prosthetic knee surgery
Revista espanola de cirugia ortopedica y traumatologia. 2022
OBJECTIVE Knee arthroplasty is a major surgery with potential significant blood loss. Assess the efficacy and safety of topical administration of 3 gr of tranexamic acid (TXA) in terms of reducing blood loss in knee arthroplasty. MATERIAL AND METHOD A randomized, phase III, double-blind, placebo-controlled clinical trial has been conducted. We included 150 patients in two parallel treatment groups (75 per arm). The solution was administered topically intra-articular after cementation and prior to capsular closure. Analytical determinations were made before and after surgery to quantify blood loss. RESULTS Total blood loss (TBL) for the placebo group was 831.5 ml and 662.3 ml for the TXA group. The difference between the two groups was 169.2 ml; which means a save of 20.4 per cent; this difference being statistically significant (p<0.001). There were no differences in terms of the onset of ambulation, days of admission or Visual Analogue Scale at one month of surgery. Ten patients were rejected for presurgical urinary tract infection, metal allergy, selection failure, patellar weakening, prosthetic instability, intrasurgical tibial fracture, change of indication to unicompartimental prosthesis and a loss of follow-up. There was only one complication unrelated to the investigational drug (bladder balloon). CONCLUSION The administration of TXA topically after cementation of the prosthetic components in total knee arthroplasty in a single dose has demonstrated being safe and effective.
Application of Different Doses of Tranexamic Acid Plus Traditional Chinese Medicine in Hip Arthroplasty in Patients with Diabetes and Its Influence on Intraoperative Blood Loss and Postoperative Drainage
Evidence-based complementary and alternative medicine : eCAM. 2022;2022:1197495
OBJECTIVE To evaluate the efficacy of different doses of tranexamic acid plus traditional Chinese medicine (TCM) in hip arthroplasty in diabetic patients and the effect on intraoperative hemorrhage and postoperative drainage. METHODS One hundred patients admitted to our hospital from January 2019 to September 2021 were randomly divided into group B (n = 50) and group A (n = 50), and tranexamic acid was injected intravenously at a dose of 10 mg/kg and 20 mg/kg 30 min before skin incision, and then tranexamic acid 1.0 g was injected into the joint cavity through the drainage after incision closure, followed by 3 h of drainage clamping. The amount of blood loss, coagulation index, postoperative drainage, and incidence of venous thromboembolism (VTE) were compared between the groups. RESULTS Group A had significantly less total blood loss, dominant blood loss, and hidden blood loss than group B (P < 0.05). No significant difference in postoperative coagulation indexes and postoperative drainage flow was found between the two groups (P > 0.05). Serological examination results demonstrated no statistical difference in D-dimer (D-D) levels between the two groups. The absence of VTE in both groups was determined by imaging. CONCLUSION Tranexamic acid is effective in reducing intraoperative hemorrhage in diabetic patients undergoing hip arthroplasty. The dose of 20 mg/kg outperforms 10 mg/kg in terms of clinical efficacy with a favorable safety profile, which can be applied according to the patient's actual condition.
Assessment of Short-Term Outcomes of Total Knee Arthroplasty Performed With and Without a Tourniquet
BACKGROUND Tourniquet use has been advocated for better visualization of the surgical field as it exsanguinates most of the blood from the limbs to the central compartment. On the contrary, its use may increase postoperative pain and recovery of quadriceps function, thereby increasing the length of stay (LOS). The study aims to assess short-term outcomes of total knee arthroplasty (TKA) performed with and without a tourniquet. METHODOLOGY Eighty-six patients scheduled for TKA either with or without a tourniquet were selected and divided into two groups using simple random sampling. Knee replacements were performed with a tourniquet in group I and without a tourniquet in group II. In all cases, blood loss was estimated. A visual analog scale (VAS) was used for the assessment of postoperative pain. In the study, range of motion (ROM) and quadriceps lag were also assessed on postoperative day 2 and discharge. RESULTS There were 23 (26.7%) males and 20 (23.2%) females in group I and 28 (32.5%) males and 15 (17.4%) females in group II (p = 0.07). On comparing mean age and body mass index (BMI), statistically insignificant results were obtained. In group I and group II, a statistically significant difference was obtained in the estimation of mean total blood loss as 780.4 ± 152.49 and 1146.2 ± 193.14 ml, respectively (p = 0.02). Neither on postoperative day 2 nor at the time of discharge, no significant results were obtained in observing the ROM at the knee joint and quadriceps lag. CONCLUSION It was found that tourniquet use is associated with lower blood loss and similar postoperative pain, ROM, quadriceps lag, and LOS.
The mid-term and long-term effects of tourniquet use in total knee arthroplasty: systematic review
Journal of experimental orthopaedics. 2022;9(1):42
PURPOSE A tourniquet is routinely used during total knee arthroplasty (TKA) to reduce intra-operative hemorrhage, though surgery without a tourniquet is becoming popular. To address concerns about the effect of blood at cement interfaces on long-term implant stability, we conducted a systematic review among patients undergoing total knee arthroplasty to determine if TKA with a tourniquet, compared to TKA without a tourniquet or with reduced tourniquet duration, is associated with better mid-term and long-term implant stability. METHODS A literature search was conducted without language restriction in PubMed, Cochrane database and Web of Science from conception to 17th March, 2021. Prospective cohorts, randomized and observational, that compared tourniquet use with a control group, followed patients for 3 months or more and reported outcomes concerning implant stability, limb function, pain and inflammation. Article selection, quality assessment according to the Revised Cochrane risk assessment scale and Newcastle Ottawa Scale, and data extraction were conducted in duplicate. PROSPERO CRD42020179020. RESULTS The search yielded 4868 articles, from which 16 randomized controlled trials (RCT) and four prospective cohort studies, evaluating outcomes of 1884 knees, were included. Eleven RCTs were evaluated to be low overall risk of bias, five RCTs had some concerns and four cohort studies were good quality. Few studies showed benefits of tourniquet use in mid-term implant stability (1/6), pain (1/11) and limb inflammation (1/5), and long-term implant stability (1/1). One study reported a significantly improved range of motion (1/14) while another reported significantly reduced quadriceps strength (1/6) in the tourniquet group. The remaining studies reported non-significant effect of tourniquet use. CONCLUSION Although few studies indicated benefits of tourniquet use in mid-term pain, limb inflammation, implant loosening and function, and long-term implant loosening, the majority of studies report no significant advantage of tourniquet use in total knee arthroplasty.
Tranexamic acid combined with compression dressing reduces blood loss in gluteal muscle contracture surgery
BMC surgery. 2022;22(1):46
BACKGROUND Blood loss and incision-related complications caused by the surgical procedure to release gluteal muscle contracture (GMC) put negative effects on the surgical outcomes. Current procedures to prevent blood loss and complications are not satisfactory. The current study aimed to determine whether tranexamic acid (TXA) in combination with pressure dressing reduce the amount of blood loss, the rate of incision-related complications, and the rate of readmission for patients undergoing surgeries to release GMC. METHODS 49 GMC patients were finally included in the study and were randomly divided into two groups: study group and control group. Patients in both groups received minimally invasive surgery to release GMC except that in the study group, patients were administered a dosage of 20 mg/kg of intravenous TXA preoperatively, and 2 subsequent dosages of TXA at 10 mg/kg at two time points: 3 and 6 h after the first dose. Gauze soaked with TXA was used to pack the wound for 10 min before the incision closure. Then the wound was pressure-wrapped with a hip-spica bandage for 24 h after the surgery in the study group. RESULTS The level of UBL in the study group was significantly lower compared to that in the control group. Similar results were also found for UMHD and UMAD. The incision-related postoperative complications were greatly decreased in the study group compared to those of the control group as well. So was the 30-day readmission rate. All patients in both groups reached "excellent" or "good" level with respect to the postoperative function evaluation. CONCLUSIONS Intravenous and topical application of TXA combined with 24 h pressure hip-spica bandage reduces perioperative blood loss, rate of incision-related complications, and the rate of readmission for GMC patients undergoing minimally invasive surgical releasing procedure. Trial Registration Chinese Clinical and Trial Registry ChiCTR2000039216, registration date 2020/10/22, retrospectively registered.
Effect of Oral Tranexamic Acid on the Blood Transfusion Rate and the Incidence of Deep Vein Thromboembolism in Patients after TKA
Evidence-based complementary and alternative medicine : eCAM. 2022;2022:6041827
PURPOSE To explore the effect of oral tranexamic acid treatment on the blood transfusion rate and the incidence of deep vein thromboembolism after total knee arthroplasty (TKA). METHODS 90 patients undergoing TKA admitted to First People's Hospital of Changshu City from January 2019 to January 2020 were selected and randomized into the control group and the experimental group accordingly (45 cases in each group). The control group intravenously received 20 mL/kg tranexamic acid before the incision was closed. The experimental group was given 1 g of tranexamic acid orally before anesthesia, 6 h and 12 h after the operation. RESULTS The experimental group witnessed better perioperative indexes in relation to the control group. The experimental group displayed better postoperative coagulation function indexes as compared to the control group (P < 0.05). Remarkably lower postoperative vascular endothelial function indexes in the experimental group than in the control group were observed. The experimental group experienced a markedly lower incidence of deep vein thromboembolism in comparison with the control group (P < 0.05). The postoperative knee society score (KSS) score of the experimental group was significantly higher than that of the control group. A significantly higher postoperative modified rivermead mobility index (MRMI) score was yielded in the experimental group in contrast to the control group (P < 0.05). The experimental group obtained lower numerical rating scale (NRS) scores at T2 and T3 as compared to the control group. CONCLUSION Oral tranexamic acid is a suitable alternative for patients undergoing TKA in terms of reducing the blood transfusion rate, relieving pain, and accelerating the recovery of the patient's limbs.
Administration of Tranexamic Acid to Reduce Intra-articular Hemarthrosis in ACL Reconstruction: A Systematic Review
Orthopaedic journal of sports medicine. 2022;10(1):23259671211061726
BACKGROUND Although tranexamic acid (TXA) has been shown to reduce bleeding in joint replacement procedures, its effectiveness for anterior cruciate ligament reconstruction (ACLR) has not been widely reported. PURPOSE To evaluate the effectiveness of TXA to reduce postoperative hemarthrosis and improve clinical outcomes after ACLR. STUDY DESIGN Systematic review; Level of evidence, 2. METHODS A systematic review of the literature following the PRISMA guidelines (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) was performed; literature retrieval was carried out using the MEDLINE, Embase, and Cochrane Library electronic databases. The inclusion criteria were comparative studies in English that reported the administration of intravenous or intra-articular TXA versus other modalities or placebo in patients undergoing ACLR. RESULTS Six studies comprising 418 patients who were treated with TXA were included. Heterogeneity among studies did not allow for the pooling of data. Five studies showed decreased drainage volume in the first 24 or 48 hours postoperatively as compared with control (ACLR with no TXA). Four studies showed lower hemarthrosis grades and visual analog scale scores in TXA versus control in the early postoperative period, although this difference was not evident at 4 weeks postoperatively. No studies showed differences in infection, deep venous thrombosis, or adverse events between the TXA and control groups. CONCLUSION The current best available evidence suggests that TXA administration at the time of ACLR results in decreased intra-articular bleeding (measured using a drainage system), hemarthrosis grade, and pain when compared with control.
Peri-Articular Injection of Tranexamic Acid Reduce Blood Loss and Transfusion Requirement During Total Knee Arthroplasty: A Meta-analysis
Geriatric orthopaedic surgery & rehabilitation. 2022;13:21514593221101264
BACKGROUND The aim of this meta-analysis was to evaluate the efficacy and safety of peri-articular injection of tranexamic acid (TXA) during total knee arthroplasty (TKA) from clinical controlled trials. METHOD Eligible scientific articles published prior to October 2021 were retrieved from the PubMed, Springer, ScienceDirect and Cochrane Library databases. The statistical analysis was performed with RevMan 5.1. RESULT 2 RCTs and 3 non-RCTs met the inclusion criteria. Meta-analysis showed significant differences in terms of hemoglobin reduction (MD = -1.04, 95% CI: -1.33 to -.76, P < .00001), total blood loss (MD = -342.80.70, 95% CI: -437.52 to -248.08, P < .00001), drainage volume (MD = -297.24, 95% CI: -497.26 to -97.23, P = .004) and blood transfusion rate (OR = .30, 95% CI: .14 to .62, P = .001) were found in the control group. No postoperative infection and deep venous thrombosis were found between 2 groups. CONCLUSION Peri-articular injection of TXA can effectively decrease perioperative blood loss and blood transfusion rate without increasing the incidence of postoperative complications during TKA.
A Randomized Controlled Study on the Use of Tourniquet in Primary Total Knee Arthroplasty
The journal of knee surgery. 2022
BACKGROUND The use and the optimal timing of tourniquet during primary total knee arthroplasty (TKA) is controversial. Most previous studies failed to show clinically significant differences in different strategies. The aim of this study was to determine how three strategies of tourniquet application affect the outcome in TKA patients. METHODS This was a prospective randomized controlled study. Patients who undergo TKA were randomized into one of the three groups (1:1:1 ratio): tourniquet inflated from skin incision to cement hardening, tourniquet from cement application to hardening, and tourniquet from skin incision to skin closure. The perioperative blood loss, limb swelling, and complications were recorded. The level of hemoglobin, hematocrit, C-reactive protein (CRP), interleukin (IL)-6, creatine kinase (CK), and lactate dehydrogenase (LDH) were determined. Patients' thigh and TKA wound pain, Knee Society knee score (KSKS) and Knee Society functional assessment (KSFA) scores, and rehabilitation parameters were evaluated. RESULTS A total of 90 patients were enrolled. The baseline characteristics were comparable. We only found significant difference in the intraoperative blood loss (skin to cement: 58.7 ± 36.1 mL, cement-only: 147.8 ± 107.9 mL, skin to skin: 16.3 ± 13.1 mL, p < 0.0001). There were no statistical differences in postoperative drainage, thigh/knee circumference, change of hemoglobin/hematocrit, CRP, IL-6, CK, and LDH on day 1 to day 4 after surgery. The thigh/TKA wound Visual Analogue Scale scores, KSKS score, KSFA score, and rehabilitation parameters were not significantly different at up to 6-month follow-up. No thromboembolic events were noted. CONCLUSION Our results revealed that there was no best tourniquet strategy in TKA. Different tourniquet methods can be utilized based on surgeon preference without affecting outcomes.
The effect of tranexamic acid in open reduction and internal fixation of pelvic and acetabular fracture: A systematic review and meta-analysis
BACKGROUND Pelvic bone fractures may cause extensive bleeding; however, the efficacy of tranexamic acid (TXA) usage in pelvic fracture surgery remains unclear. In this systematic review and meta-analysis, we aimed to evaluate the efficacy of TXA in open reduction and internal fixation surgery for pelvic and acetabular fracture. METHODS MEDLINE, Embase, and Cochrane Library databases were systematically searched for studies published before April 22, 2020, that investigated the effect of TXA in the treatment of pelvic and acetabular fracture with open reduction and internal fixation. A pooled analysis was used to identify the differences between a TXA usage group and a control group in terms of estimated blood loss (EBL), transfusion rates, and postoperative complications. RESULTS We included 6 studies involving 764 patients, comprising 293 patients who received TXA (TXA group) and 471 patients who did not (control group). The pooled analysis showed no differences in EBL between the groups (mean difference -64.67, 95% confidence interval [CI] -185.27 to -55.93, P = .29). The study period transfusion rate showed no significant difference between the groups (odds ratio [OR] 0.77, 95% CI 0.19-3.14, P = .71, I2 = 82%), nor in venous thromboembolism incidence (OR 1.53, 95% CI 0.44-5.25, P = .50, I2 = 0%) or postoperative infection rates (OR 1.15, 95% CI 0.13-9.98, P = .90, I2 = 48%). CONCLUSIONS Despite several studies having recommended TXA administration in orthopedic surgery, our study did not find TXA usage to be more effective than not using TXA in pelvic and acetabular fracture surgery, especially in terms of EBL reduction, transfusion rates, and the risk of postoperative complications.