The effect of perioperative tranexamic acid (TXA) in patients with calcaneal fractures: a meta-analysis and systematic review of randomized controlled trials
Journal of orthopaedic surgery and research. 2023;18(1):495
BACKGROUND Calcaneal fractures are a common orthopedic disease, account for approximately 2% of all bone fractures, and represent 60% of fractures of tarsal bones. Tranexamic acid (TXA) is a synthetic antifibrinolytic drug that competitively blocks the lysine-binding sites of plasminogen, plasmin, and tissue plasminogen activator, delaying fibrinolysis and blood clot degradation. However, the effect of TXA on patients with calcaneal surgery remains controversial. Our objective was to evaluate the effectiveness of TXA in calcaneal fractures surgeries. METHODS The electronic literature databases of Pubmed, Embase, and Cochrane library were searched in December 2022. The data on blood loss, the stay in the hospital, the duration of surgery, hemoglobin, hematocrit, platelet count, prothrombin time, activated partial thromboplastin time, and wound complication were extracted. The Stata 22.0 software was used for the meta-analysis. RESULTS Four randomized controlled studies met our inclusion criteria. This meta-analysis showed that TXA significantly reduced postoperative blood loss during the first 24 h (p < 0.001), improved the level of hemoglobin (p < 0.001) and hematocrit (p = 0.03), and reduced the risk of wound complications (p = 0.04). There was no significant difference between the two groups regarding total and intraoperative blood loss, hospital stay, duration of surgery, platelet count, activated partial thromboplastin time, and prothrombin time. CONCLUSION TXA significantly reduced blood loss during the first 24 h postoperatively, improved the level of hemoglobin and hematocrit, and reduced the risk of wound complications. Given the evidence, TXA can be used in patients with calcaneal fractures and had the potential benefit of blood reduction. PROTOCOL REGISTRATION The protocol was registered in PROSPERO (registration No. CRD42023391211).
Effects of combined dexamethasone and tranexamic acid in lower limb total arthroplasty: a systematic review and meta-analysis of randomized clinical trials
European journal of orthopaedic surgery & traumatology : orthopedie traumatologie. 2023
PURPOSE To evaluate the effectiveness of combined Tranexamic acid (TXA) and dexamethasone (DEX) in total hip and knee arthroplasty. METHODS PUBMED, EMBASE, MEDLINE and CENTRAL database were systematically searched for randomized studies that utilized TXA and DEX administration of TXA in THA or TKA. RESULTS A total of three randomized studies enrolling 288 patients were eligible for qualitative and quantitative analysis. DEX + TXA group demonstrated statistical significantly lesser usage of oxycodone (OR: 0.34, p < 0.0001), metoclopramide (OR: 0.21, p < 0.00001), lesser incidence of postoperative nausea and vomiting (OR: 0.27, p < 0.0001), better postoperative range of motion (MD: 2.30, p < 0.00001) and shorter length of hospital stay (MD: 0.31, p = 0.03). Comparable results were seen in total blood loss, transfusion rate and postoperative complications. CONCLUSION In this meta-analysis, the combination of TXA and DEX has positive impacts on the usage of oxycodone and metoclopramide, postoperative range of motion, postoperative nausea and vomiting and reduces the length of hospital stay.
Tranexamic acid administration for arthroscopic rotator cuff repair: A prospective, double-blind, randomized controlled trial
Journal of Orthopaedic Science : Official Journal of the Japanese Orthopaedic Association. 2023;28(2):328-332
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.
The Impact of Tourniquet Usage on TKA Outcome: A Single-Center Prospective Trial
Medicina (Kaunas, Lithuania). 2023;59(5)
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.
Safety and Efficacy of Tranexamic Acid in Hip Hemiarthroplasty for Fracture Neck Femur: a Systematic Review and Meta-analysis
Indian journal of orthopaedics. 2023;57(1):33-43
PURPOSE Although numerous systematic reviews and meta-analyses have established the efficacy of tranexamic acid (TXA) in hip fracture surgeries, the included studies in those reviews have included all types of surgical interventions ranging from fixation to arthroplasty. Hip hemiarthroplasty is usually indicated in the elderly patients with femoral neck fracture and these patients have associated severe comorbidities and cognitive impairment. These subsets of patients with femoral neck fracture needs appropriate perioperative care and judicious use of antifibrinolytics. There is no meta-analysis evaluating the safety and efficacy of intravenous TXA in these patients. METHODS Searches of PubMed, Embase and Cochrane Central Register of Controlled Trials databases revealed 102 studies on TXA in hip fracture surgeries. After screening, eight studies were found to be suitable for review. The primary objective of this meta-analysis was to compare blood transfusion rate between TXA vs. control in hip hemiarthroplasty. The secondary objectives were total blood loss, postoperative haemoglobin, surgical duration, length of hospital stay and side effects (VTE, readmission and 30 days mortality). RESULTS There were one RCT, one prospective cohort study and six retrospective studies. All studies recruited the elderly patients. Intravenous (IV) TXA administration resulted in significant reduction in requirement of blood transfusion (12.7% vs. 31.9%; OR 0.28; 95% CI 0.17-0.46; p < 00,001; I (2) = 73%). The TXA group had significantly decreased total blood loss (MD - 100.31; 95% CI - 153.79, - 46.83; p < 0.0002). The postoperative Hb in the TXA group was significantly higher than the control group (MD 0.53; 95% CI 0.35, 0.71; p < 0.00001). There was no significant difference in the incidences of VTE (0.97% vs. 0.73%, OR 1.27; p = 0.81; I (2) = 64%) and readmission rate (9.2% vs. 9.64%; OR 0.79; p = 0.54), but 30-d mortality rate was significantly lower in the TXA group (3.41% vs. 6.04%; OR 0.66; p = 0.03). CONCLUSIONS Intravenous TXA is efficacious in the reduction of blood loss and transfusion need in hip hemiarthroplasty surgery for hip fracture, without increased risk of VTE. The blood conservation protocol led to decreased 30 days mortality in these fragile elderly patients. LEVEL OF EVIDENCE III.
Efficacy of perioperative cryotherapy combined with intra-articular injection of tranexamic acid in total knee arthroplasty
OBJECTIVE To evaluate the efficacy and safety of perioperative cryotherapy combined with intra-articular injection of tranexamic acid (TXA) in total knee arthroplasty (TKA) and explore a new strategy of enhanced recovery after TKA. METHODS We randomly divided 200 patients into 4 groups: normal saline (10 mL) by drainage (Group A, placebo); intra-articular injection of TXA (1 g, 10 mL, Group B); normal saline (10 mL) and continuous cryotherapy postoperatively (Group C) and intra-articular injection of TXA (1 g, 10 mL) and continuous cryotherapy postoperatively (Group D). Primary outcomes were blood loss volume, postoperative pain and circumference variation. We also recorded consumption of analgesics, postoperative length of stay (p-LOS), range of motion (ROM), function score (Hospital for Special Surgery) and severe complications. RESULTS There were statistically significant differences in postoperative drainage volume, total blood loss, hidden blood loss, and visual analogue scale at rest and walking on postoperative day 1 (POD1), POD2, POD3, ROM (POD3, 7, discharge, postoperative month), circumference variation (POD3, 7), p-LOS, Hospital for Special Surgery score (discharge) and drop of hemoglobin on POD3 (P < .05) among 4 groups, but there were no significant differences in intraoperative blood loss, postoperative prothrombin, activated partial thromboplastin time, overall number of patients or total consumption of oxycodone and perioperative complications (e.g., incidence of surgical site infection, deep venous thrombosis, and cold injury) among them (P > .05). CONCLUSION Continuous cryotherapy combined with intra-articular injection of TXA provides short-term advantages in reducing blood loss, pain, postoperative swelling, p-LOS and increasing ROM and joint function in the early postoperative period after TKA without increasing any severe complications.
Efficacy of intravenous tranexamic acid administration in medial opening-wedge distal tibial tuberosity osteotomy (MOWDTO) for varus knee osteoarthritis: a randomized control trial
Journal of Orthopaedic Surgery and Research. 2023;18(1):178
BACKGROUND This randomized controlled study was undertaken to investigate the efficacy of intravenous tranexamic acid (TXA) administration in reducing perioperative blood loss in patients undergoing medial opening-wedge distal tibial tuberosity osteotomy (MOWDTO). It was hypothesized that TXA would reduce perioperative blood loss in MOWDTO. METHODS A total of 61 knees in 59 patients who underwent MOWDTO during the study period were randomly assigned to either of the groups with intravenous TXA administration (TXA group) or without TXA administration (control group). In the TXA group, patients received 1000 mg of TXA intravenously before skin incision and 6 h after the first dose. The primary outcomes was the volume of perioperative total blood loss which calculated using the blood volume and hemoglobin (Hb) drop. The Hb drop was calculated as the difference between preoperative Hb and postoperative Hb at days 1, 3, and 7. RESULTS The perioperative total blood loss was significantly lower in the TXA group (543 ± 219 ml vs. 880 ± 268 ml, P < 0.001). The Hb drop was significantly lower at postoperative days 1, 3 and 7 in the TXA group than in the control group (day 1: 1.28 ± 0.68 g/dl vs. 1.91 ± 0.69 g/dl, P = 0.001; day 3: 1.54 ± 0.66 g/dl vs. 2.69 ± 1.00 g/dl, P < 0.001; day 7: 1.74 ± 0.66 g/dl vs. 2.83 ± 0.91 g/dl, P < 0.001). CONCLUSION Intravenous TXA administration in MOWDTO could reduce the perioperative blood loss. Trial registration The study was approved by the institutional review board. (Registered on 26/02/2019 Registration Number 3136). Level of Evidence Level I, randomized controlled trial.
Ferric derisomaltose and tranexamic acid, combined or alone, for reducing blood transfusion in patients with hip fracture (the HiFIT trial): a multicentre, 2 × 2 factorial, randomised, double-blind, controlled trial
The Lancet. Haematology. 2023
BACKGROUND Anaemia and blood transfusion are associated with poor outcomes after hip fracture. We evaluated the efficacy of intravenous iron and tranexamic acid in reducing blood transfusions after hip fracture surgery. METHODS In this double-blind, randomised, 2 × 2 factorial trial, we recruited adults hospitalised for hip fractures in 12 medical centres in France who had preoperative haemoglobin concentrations between 9·5 and 13·0 g/dL. We randomly allocated participants (1:1:1:1), via a secure web-based service, to ferric derisomaltose (20 mg/kg intravenously) and tranexamic acid (1 g bolus followed by 1 g over 8 h intravenously at inclusion and 3 g topically during surgery), iron plus placebo (normal saline), tranexamic acid plus placebo, or double placebo. Unmasked nurses administered study drugs; participants and other clinical and research staff remained masked to treatment allocation. The primary outcome was the percentage of patients transfused during hospitalisation (or by day 30). The primary analysis included all randomised patients. This study is registered on ClinicalTrials.gov (NCT02972294) and is closed to new participants. FINDINGS Of 413 patients (51-104 years old, median [IQR] 86 [78-91], 312 [76%] women, 101 [24%] men), 104 received iron plus tranexamic acid, 103 iron plus placebo, 103 tranexamic acid plus placebo, and 103 double placebo between March 31, 2017 and June 18, 2021 (study stopped early for efficacy after the planned interim analysis done on the first 390 patients included on May 25, 2021). Data for the primary outcome were available for all participants. Among patients on double placebo, 31 (30%) were transfused versus 16 (15%) on both drugs (relative risk 0·51 [98·3% CI 0·27-0·97]; p=0·012). 27 (26%) participants on iron (0·81 [0·50-1·29]; p=0·28) and 28 (27%) on tranexamic acid (0·85 [0·54-1·33]; p=0·39) were transfused. 487 adverse events were reported with similar event rates among the groups; among prespecified safety endpoints, severe postoperative anaemia (haemoglobin <8 g/dL) was more frequent in the double placebo group. Main common adverse event were sepsis, pneumonia, and urinary infection, with similar rates among all groups. INTERPRETATION In patients hospitalised for hip fracture surgery with a haemoglobin concentration 9·5-13·0 g/dL, preoperative infusion of ferric derisomaltose plus tranexamic acid reduced the risk of blood transfusion by 50%. Our results suggest that combining treatments from two different pillars improves patient blood-management programmes. Either treatment alone did not reduce transfusion rates, but we might not have had the power to detect it. FUNDING French Ministry of Health, HiFIT trial.
Adults hospitalised for hip fractures in 12 medical centres in France, enrolled in the Hip Fracture Iron and Tranexamic acid (HiFIT) trial (n= 413).
Iron plus tranexamic acid (n= 104).
Iron plus placebo (n= 103). Tranexamic acid plus placebo (n= 103). Double placebo (n= 103).
Among patients on double placebo, 31 (30%) were transfused vs. 16 (15%) on both drugs (relative risk 0.51; 98.3% CI [0.27, 0.97]); 27 (26%) participants on iron (relative risk 0.81; 98.3% CI [0.50, 1.29]) and 28 (27%) on tranexamic acid (relative risk 0.85; 98.3% CI [0.54, 1.33]) were transfused. 487 adverse events were reported with similar event rates among the groups; among prespecified safety endpoints, severe postoperative anaemia (haemoglobin <8 g/dL) was more frequent in the double placebo group. Main common adverse events were sepsis, pneumonia, and urinary infection, with similar rates among all groups.
Tourniquet use for people with peripheral arterial disease undergoing major lower limb amputations
The Cochrane database of systematic reviews. 2023;7(7):Cd015232
BACKGROUND At least 7000 major lower limb amputations (MLLAs) are performed in the UK each year, 80% of which are due to peripheral arterial disease (PAD). Intraoperative blood loss can have a deleterious effect on patient outcomes, and its replacement with transfused blood is not without risk. Tourniquets can be used in lower limb surgical procedures to provide a bloodless surgical field, minimise intraoperative blood loss, and reduce perioperative blood transfusion requirements. Although their safety has been demonstrated in certain orthopaedic operations, their use among people with PAD undergoing MLLA remains controversial. Many clinicians are concerned about tourniquets potentially compromising perfusion of the stump and thereby impacting wound healing through direct tissue injury, damage to the arterial supply of the wound, or both. OBJECTIVES To assess the safety and effectiveness of tourniquet use in people undergoing MLLA for complications of PAD, specifically with regard to intraoperative blood loss, change in haemoglobin levels, transfusion rates, wound healing, need for revision surgery, and postoperative complications including mortality. SEARCH METHODS We searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, and CINAHL databases and World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers from inception to 17 May 2022. SELECTION CRITERIA We included randomised controlled trials (RCTs) comparing tourniquet use to no tourniquet use among people with PAD undergoing MLLA. DATA COLLECTION AND ANALYSIS We used standard Cochrane methods. Primary outcomes were intraoperative blood loss, fall in haemoglobin levels, and perioperative blood transfusion requirement. Secondary outcomes were primary wound-healing rates, stump revision rates, other postoperative complications defined as per Clavien-Dindo classification, and postoperative mortality at 30 days and at maximal follow-up. We used GRADE to assess the certainty of evidence for each outcome. MAIN RESULTS One RCT met our inclusion criteria, which was a prospective randomised blinded controlled trial conducted in Sheffield, UK in 2006. In total 64 participants undergoing transtibial amputation for non-reconstructable PAD were randomised to either tourniquet or no tourniquet to assess for intraoperative blood loss, fall in haemoglobin, transfusion requirement, wound healing, stump breakdown and revision. Ten participants were excluded postrandomisation (five from the tourniquet group and five from the no tourniquet group). The reported median volume of intraoperative blood loss was significantly less in the tourniquet group (255 mL (interquartile range (IQR) 150 to 572.5 mL))) compared to the control group (550 mL (IQR 255 to 1050 mL)) (P = 0.014). There was a significantly lower median drop in haemoglobin concentration in the tourniquet group (1.0 g/dL (IQR 0.6 to 2.4 g/dL)) compared to the control group (1.8 g/dL (IRQ 0 to 1.2 g/dL)) (P = 0.035). There was a significantly lower perioperative blood transfusion requirement in the tourniquet group (8 participants, 32%) compared to the control group (14 participants, 48%) (P = 0.047). There were no clear differences in wound breakdown, stump revision, primary wound healing at six weeks, postoperative complications (myocardial infarction, cardiac arrhythmias, pulmonary oedema), and death between groups. We assessed the one included study as at low risk of bias for sequence generation and blinding of outcome assessors; high risk of bias for incomplete outcome data and selective outcome reporting; and unclear risk of bias for allocation concealment, blinding of participants and personnel, and other sources of bias. We assessed the certainty of the evidence as low or very low due to risk of bias, small sample size, and the study being insufficiently powered for most outcomes. AUTHORS' CONCLUSIONS This review identified only one small historical RCT evaluating tourniquet use in MLLA. Tourniquets appeared to reduce intraoperative blood loss, drop in haemoglobin, and blood transfusion requirements following transtibial amputations for people with PAD. However, it is unclear whether tourniquets affect wound healing, stump revision rates, postoperative complications, or mortality. High-certainty evidence is required to inform clinical decision-making for the use of tourniquets in these patients.
The Effect of Tourniquet Duration on Pain, Bleeding, and Functional Outcomes in Total Knee Arthroplasty
Objective The aim of this study was to evaluate the effects of tourniquet use on perioperative blood loss, pain, and functional and clinical outcomes. Patients and methods This is a prospective study that included 80 knees who underwent total knee arthroplasty. The patients were separated into two groups: those with a tourniquet used throughout the entire surgical procedure and those where the tourniquet was only used during the cementation procedure. In the postoperative period, the pain levels of the patients were evaluated using a visual analog scale (VAS), and the functional results were evaluated with knee range of motion measurement, the Western Ontario and Mcmaster Universities Osteoarthritis (WOMAC) index, the Knee Injury and Osteoarthritis Outcome Score (KOOS), the Kujala Patellofemoral Scoring System, and the Oxford Knee Scoring system. The patients were examined in the early postoperative period and again in the 12th week, including possible complications that may develop postoperatively. Results In the early postoperative period, a greater hemoglobin decrease and calculated blood loss values, better functional clinical results, and better knee range of motion were determined in the group with a tourniquet applied only during the cementation, and the swelling in the knee was less (p<0.05). However, the difference between the two groups had disappeared by the postoperative 12th week. There was no significant difference in respect of complications. Conclusion Limiting the duration of tourniquet use during total knee arthroplasty has the significant advantage of providing better functional results with less pain in the early postoperative period.