Abstract

INTRODUCTION AND AIM OF STUDY Tranexamic acid has been found to be effective in reducing peri-operative blood loss and is widely used across surgical specialties including orthopaedic surgery. However, there is still no consensus on the most appropriate and effective dose regimen. This study therefore compared the efficacy of single versus double dose regimens in patients that had interlocking intramedullary nailing by assessing the volume of drain output with the objective of determining the more effective regimen. METHODS The study was a multicenter prospective study amongst adult patients who had interlocking intramedullary nailing for femoral nonunions. Following ethical approval, consent was obtained from eligible patients who were randomly assigned into two study groups. Group A patients had single pre-incision tranexamic acid bolus of one gram while group B patients had a second (repeat) one gram bolus (at the completion of wound closure). The volume of drain output at 48 h postop was the primary outcome measure and data collection was via an online data collection form linked to the google drive of the principal investigator. The mean of the drain output of the two groups was compared for statistical significance. RESULTS A total of 61 patients participated in the study with 30 patients in group A and 31 patients in group B. The demographic data and duration of fracture were comparable in the two groups. Group A had a mean drain volume of 274.80 ml (± 103.93 ml) while group B had a mean of 187.94 ml (± 41.95 ml) and the difference was found to be statistically significant. (P, 0.000). CONCLUSION The findings suggest that double dose perioperative tranexamic acid regimen is superior to single-dose peri-operative tranexamic acid regimen in reducing post-operative blood loss in patients undergoing interlocking intramedullary nailing for femoral nonunions.

Abstract

AIMS: A typical pattern of blood loss associated with total hip arthroplasty (THA) is 200 ml intraoperatively and 1.3 l in the first 48 postoperative hours. Tranexamic acid (TXA) is most commonly given as a single preoperative dose only and is often withheld from patients with a history of thromboembolic disease as they are perceived to be "high-risk" with respect to postoperative venous thromboembolism (VTE). The TRanexamic ACid for 24 hours trial (TRAC-24) aimed to identify if an additional 24-hour postoperative TXA regime could further reduce blood loss beyond a once-only dose at the time of surgery, without excluding these high-risk patients. METHODS TRAC-24 was a prospective, phase IV, single centre, open label, parallel group, randomized controlled trial (RCT) involving patients undergoing primary unilateral elective THA. The primary outcome measure was the indirect calculated blood loss (IBL) at 48 hours. The patients were randomized into three groups. Group 1 received 1 g intravenous (IV) TXA at the time of surgery and an additional oral regime for 24 hours postoperatively, group 2 only received the intraoperative dose, and group 3 did not receive any TXA. RESULTS A total of 534 patients were randomized, with 233 in group 1, 235 in group 2, and 66 in group 3; 92 patients (17.2%) were considered high-risk. The mean IBL did not differ significantly between the two intervention groups (848.4 ml (SD 463.8) for group 1, and 843.7 ml (SD 478.7) for group 2; mean difference -4.7 ml (95% confidence interval -82.9 to 92.3); p = 0.916). No differences in mortality or incidence of VTE were observed between any group. CONCLUSION The addition of oral TXA for 24 hours postoperatively does not reduce blood loss beyond that achieved with a single 1 g IV perioperative dose alone. There may be a clinically relevant difference in patients with a normal BMI, which warrants further investigation. Critically, there were no safety issues in patients with a history of thromboembolic, cardiovascular, or cerebrovascular disease. Cite this article: Bone Joint J 2021;103-B(7):1197-1205.

Abstract

BACKGROUND We aimed to determine the efficacy of preemptive antifibrinolysis with tranexamic acid (TXA) in decreasing hidden blood loss (HBL) in the elderly hip fracture patients. METHODS 96 elderly hip fracture patients receiving hip arthroplasty were randomized to receive 100 ml of normal-saline (Group A) or 1.5 g of TXA (Group B) intravenously q12h from post-admission day 1 (PAD1) to the day before surgery. Both groups were treated with 1.5 g of TXA q12h from postoperative day 1 (POD1) to POD3. HBL was calculated by formulas and recorded as the primary outcome. RESULTS In overall analyses, no difference was found in HBL, while the decline-of-hemoglobin (ΔHb), allogeneic-blood-transfusion (ABT) rate, fibrinogen-degradation-product (FDP, on PAD2, PAD3, POD1 and POD2) and D-dimer (D-D, on PAD2, PAD3 and POD1) were lower in Group B. In subgroup analyses for patients receiving intervention within 72 hours of injury, Group B had lower postoperative HBL, ΔHb, ABT rate, FDP and D-D levels (on PAD2, PAD3, POD1 and POD2). For patients receiving intervention over 72 hours after injury, no difference was detected in perioperative HBL, ΔHb, ABT rate between the two groups. The FDP and D-D levels were lower in Group B on PAD2 and PAD3. No difference was found in coagulation parameters, wound complications, VTE rate and 90-day mortality in all analyses. CONCLUSION Early administration (within 72 hours of injury) of multi-dose of TXA is effective in reducing perioperative HBL in elderly hip fracture patients. Delayed use (over 72 hours after injury) of TXA was not beneficial.

Abstract

BACKGROUND Many surgeons prefer to perform total knee replacement surgery with the aid of a tourniquet. A tourniquet is an occlusive device that restricts distal blood flow to help create a bloodless field during the procedure. A tourniquet may be associated with increased risk of pain and complications. OBJECTIVES To determine the benefits and harms of tourniquet use in knee replacement surgery. SEARCH METHODS We searched MEDLINE, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) up to 26 March 2020. We searched clinicaltrials.gov, the World Health Organization trials portal, and several international registries and joint registries up to March 2020. SELECTION CRITERIA We included randomised controlled trials (RCTs) comparing knee replacement with use of a tourniquet versus without use of a tourniquet and non-randomised studies with more than 1000 participants. Major outcomes included pain, function, global assessment of success, health-related quality of life, serious adverse events (including venous thromboembolism, infection, re-operation, and mortality), cognitive function, and survival of the implant. Minor outcomes included blood loss, economic outcomes, implant stability, and adverse events. DATA COLLECTION AND ANALYSIS Two review authors screened abstracts and full texts, extracted data, performed risk of bias assessments, and assessed the certainty of the evidence using the GRADE approach. MAIN RESULTS We included 41 RCTs with 2819 participants. Trials included from 20 to 199 participants. Mean age ranged between 58 and 84 years. More than half of the RCTs had unclear risk of selection bias and unclear risk of performance and detection bias due to absence of blinding of participants and surgeons. Major outcomes Pain: at postoperative day 1, pain (on a scale from zero to 10, with higher scores indicating worse pain) was ranked at 4.56 points after surgery without a tourniquet and at 1.25 points (MD) higher (95% CI 0.32 higher to 2.19 higher) with a tourniquet (8 studies; 577 participants), for an absolute difference of 12.5% higher pain scores (95% CI 3.2% higher to 21.9% higher) and a relative difference of 19% higher pain scores (95% CI 3.4% higher to 49% higher) with a tourniquet. Evidence for these findings was of moderate certainty, downgraded due to risk of bias. Knee replacement with a tourniquet probably led to higher postoperative pain scores at day 1, although this difference may or may not be noticeable to patients (based on a minimal clinically important difference (MCID) of 1.0). Function: at 12 months, tourniquet use probably makes little or no difference to function, based on an MCID of 5.3 for Knee Society Score (KSS) and 5.0 for Oxford Knee Score (OKS). Mean function (on a scale from 0 to 100, with higher scores indicating better outcomes) was 90.03 points after surgery without a tourniquet and was 0.29 points worse (95% CI 1.06 worse to 0.48 better) on a 0 to 100 scale, absolute difference was 0.29% worse (1.06% worse to 0.48% better), with a tourniquet (5 studies; 611 participants). This evidence was downgraded to moderate certainty due to risk of bias. Global assessment of success: low-certainty evidence (downgraded due to bias and imprecision) indicates that tourniquet use may have little or no effect on success. At six months, 47 of 50 (or 940 per 1000) reported overall successful treatment after surgery without a tourniquet and 47 of 50 (or 940 per 1000) with a tourniquet (risk ratio (RR) 1.0, 95% CI 0.91 to 1.10) based on one study with 100 participants. Health-related quality of life: at six months, tourniquet may have little or no effect on quality of life. The 12-Item Short Form Survey (SF-12) score (mental component from zero to 100 (100 is best)) was 54.64 after surgery without a tourniquet and 1.53 (MD) better (95% CI 0.85 worse to 3.91 better) with a tourniquet (1 study; 199 participants); absolute difference was 1.53% better (0.85% worse to 3.91% better). Evidence was of low certainty, downgraded due to risk of bias and small number of participants. Serious adverse events: the risk of serious adverse events was probably higher with tourniquet; 26 of 898 (29 per 1000) reported events following surgery without a tourniquet compared to 53 of 901 (59 per 1000) with a tourniquet (RR 1.73, 95% CI 1.10 to 2.73) in 21 studies (1799 participants). Twenty-nine more per 1000 patients (95% CI 3 to 50 more per 1000 patients) had a serious adverse event with a tourniquet. Forty-eight (95% CI 20 to 345) participants would need to have surgery without a tourniquet to avoid one serious adverse event. This evidence was downgraded to moderate certainty due to risk of bias. Cognitive function: one study reported cognitive function as an outcome; however the data were incompletely reported and could not be extracted for analysis. Survival of implant: it is uncertain if tourniquet has an effect on implant survival due to very low certainty evidence (downgraded for bias, and twice due to very low event rates); 2 of 107 (19 per 1000) required revision surgery in the surgery with a tourniquet group compared to 1 of 107 (9 per 1000) without a tourniquet group at up to two years' follow-up (RR 1.44, 95% CI 0.23 to 8.92). This equates to a 0.4% (0.7% lower to 7% more) increased absolute risk in surgery with a tourniquet. AUTHORS' CONCLUSIONS Moderate certainty evidence shows that knee replacement surgery with a tourniquet is probably associated with an increased risk of serious adverse events. Surgery with a tourniquet is also probably associated with higher postoperative pain, although this difference may or may not be noticeable to patients. Surgery with a tourniquet does not appear to confer any clinically meaningful benefit on function, treatment success or quality of life. Further research is required to explore the effects of tourniquet use on cognitive function and implant survival, to identify any additional harms or benefits. If a tourniquet continues to be used in knee replacement surgery, patients should be informed about the potential increased risk of serious adverse events and postoperative pain.

Abstract

PURPOSE The aim of the study is to show the therapeutic efficacy, safety, and cost-benefit of using tranexamic acid (TXA), as well as the superiority of the route of administration and amount of dose in primary cementless total hip replacement (THR). METHODS In this prospective, randomized, double-blind study, we divided 200 patients into five groups of 40 patients each. The placebo group did not receive TXA. Three groups received 2 g TXA each (intravenous, topical, and combined intravenous + topical), while the fifth, combined + group, received 4 g TXA. Total blood loss was calculated, number of transfusions and thromboembolic vascular incidents were monitored, and a cost-benefit analysis of the use of TXA was performed. RESULTS Regardless of the route of administration, TXA statistically significantly reduced total blood loss (p = 0.000) and the need for transfusion (p = 0.000) compared with placebo. Total blood loss and the need for allogenic blood transfusion were statistically significantly reduced in the combined + group compared with placebo, and also compared with all other groups. Post-operative thromboembolic vascular incidents were not reported. The cost-benefit of using TXA in THR is associated with reduction of transfusion costs. CONCLUSIONS None of the TXA administration routes are superior to others, but multiple doses could statistically significantly reduce blood loss and transfusion requirements, which should be the subject of future researches.

Abstract

INTRODUCTION We hypothesised that a single preoperative intravenous dose of tranexamic acid (TXA) is effective in patients who undergo total hip arthroplasty (THA) and are at high risk of blood transfusion (preoperative haemoglobin level <13.0 g/dL). METHODS A prospective, randomised controlled study of 308 patients who underwent primary THA was conducted. 256 participants remained in the study and were divided into 2 major groups: high-risk group comprising 116 patients with preoperative Hb < 13.0 g/dL (57 of whom were treated with a 15 mg/kg intravenous bolus of TXA, and 59 of whom did not receive the medication) and low-risk group comprising 140 patients with Hb 13.0 g/dL (71 of whom received the same dose of TXA, and 69 of whom did not). Participants were followed up at 3 weeks, 3 months, 6 months, and 1 year after surgery. RESULTS The use of TXA in both groups of patients significantly increased the levels of postoperative Hb and Ht. TXA protected high-risk patients from blood loss and from transfusion. In low-risk patients the use of TXA reduced blood loss but did not protect from blood transfusion. The median length of stay was significantly affected for high-risk patients. No thromboembolic event was recorded in either group. CONCLUSIONS TXA reduces intra- and postoperative bleeding, transfusion rates, and the length of hospital stays in patients with low preoperative Hb. The use of TXA in patients with normal preoperative Hb reduces blood loss but does not affect the transfusion rate. ClinicalTrials.gov Identifier: NCT03019198.