Dataset Information

Effectiveness of oral versus intravenous tranexamic acid in primary total hip and knee arthroplasty: a randomised, non-inferiority trial.

ABSTRACT:

Background

Tranexamic acid (TXA) reduces rates of blood transfusion for total hip arthroplasty (THA) and total knee arthroplasty (TKA). Although the use of oral TXA rather than intravenous (i.v.) TXA might improve safety and reduce cost, it is not clear whether oral administration is as effective.

Methods

This noninferiority trial randomly assigned consecutive patients undergoing primary THA or TKA under neuraxial anaesthesia to either one preoperative dose of oral TXA or one preoperative dose of i.v. TXA. The primary outcome was calculated blood loss on postoperative day 1. Secondary outcomes were transfusions and complications within 30 days of surgery.

Results

Four hundred participants were randomised (200 THA and 200 TKA). The final analysis included 196 THA patients (98 oral, 98 i.v.) and 191 TKA patients (93 oral, 98 i.v.). Oral TXA was non-inferior to i.v. TXA in terms of calculated blood loss for both THA (effect size=-18.2 ml; 95% confidence interval [CI], -113 to 76.3; P<0.001) and TKA (effect size=-79.7 ml; 95% CI, -178.9 to 19.6; P<0.001). One patient in the i.v. TXA group received a postoperative transfusion. Complication rates were similar between the two groups (5/191 [2.6%] oral vs 5/196 [2.6%] i.v.; P=1.00).

Conclusions

Oral TXA can be administered in the preoperative setting before THA or TKA and performs similarly to i.v. TXA with respect to blood loss and transfusion rates. Switching from i.v. to oral TXA in this setting has the potential to improve patient safety and decrease costs.

SUBMITTER: DeFrancesco CJ

PROVIDER: S-EPMC9900725 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature

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Publications

Effectiveness of oral versus intravenous tranexamic acid in primary total hip and knee arthroplasty: a randomised, non-inferiority trial.

DeFrancesco Christopher J CJ Reichel Julia F JF Gbaje Ejiro E Popovic Marko M Freeman Carrie C Wong Marisa M DeMeo Danya D Liu Jiabin J Gonzalez Della Valle Alejandro A Ranawat Amar A Cross Michael M Sculco Peter K PK Haskins Stephen S Kim David D Maalouf Daniel D Kirksey Meghan M Jules-Elysee Kethy K Soffin Ellen M EM Kumar Kanupriya K Beathe Jonathan J Figgie Mark M Inglis Allan A Garvin Sean S Alexiades Michael M DelPizzo Kathryn K Russell Linda A LA Sideris Alexandra A Saleh Jawad J Zhong Haoyan H Memtsoudis Stavros G SG

British journal of anaesthesia 20221214 2

<h4>Background</h4>Tranexamic acid (TXA) reduces rates of blood transfusion for total hip arthroplasty (THA) and total knee arthroplasty (TKA). Although the use of oral TXA rather than intravenous (i.v.) TXA might improve safety and reduce cost, it is not clear whether oral administration is as effective.<h4>Methods</h4>This noninferiority trial randomly assigned consecutive patients undergoing primary THA or TKA under neuraxial anaesthesia to either one preoperative dose of oral TXA or one preo ...[more]

PMID: 36526484

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Project description:BackgroundThe efficacy and safety of oral tranexamic acid (TXA) remain controversial because of the small number of clinical studies. The aim of the present study was to compare the efficacy and safety of oral TXA with intravenous TXA in patients undergoing total hip arthroplasty and total knee arthroplasty in a systematic review and meta-analysis.MethodsWe conducted a meta-analysis to identify randomized controlled trials (RCTs) involving oral and intravenous TXA in total hip arthroplasty and total knee arthroplasty up to December 2019 by searching databases including PubMed, Web of Science, Embase, the Cochrane Controlled Trials Register, the Cochrane Library China Biology Medicine, China National Knowledge Infrastructure, China Science and Technology Journal Database and Wanfang. The mean difference or standard mean difference was used to assess continuous outcomes such as hemoglobin (Hb) drop, total blood loss, drain blood loss, and length of hospital stay, with a 95% confidence interval. Relative risks with a 95% confidence interval were used to assess dichotomous outcomes such as transfusion rate and the incidence of deep venous thrombosis and calf muscular vein thrombosis. Review Manager was used for the meta-analysis.ResultsTen RCTs containing 1080 participants met the inclusion criteria. We found no significant differences in terms of the average Hb drop (P = .60), total blood loss (P = .60), transfusion rate (P = .99), drain blood loss (P = .91), length of hospital stay (P = .95), and the incidence of deep venous thrombosis (P = .55) and calf muscular vein thrombosis (P = .19) between oral and IV TXA.ConclusionsCompared with the IV TXA, oral TXA has similar effects on reducing the Hb drop, total blood loss, transfusion rate, drain blood loss, and length of hospital stay without increasing the risk of calf muscular vein thrombosis and deep venous thrombosis. Furthermore, oral TXA is easy to access and administer, which decreases the workload of nurses and even delivers cost-saving benefits to the health care system. We thus conclude that oral TXA may be an optimal approach in total joint arthroplasty. However, more high-quality and multicenter RCTs are still needed to confirm our conclusions.RegistrationThe current meta-analysis was registered on PROSPERO (International Prospective Register of Systematic Reviews), and the registration number was CRD42018111291.

Project description:ObjectiveThis study aimed to compare the effects of intravenous, topical and combined routes of tranexamic acid (TXA) administration on blood loss and transfusion requirements in patients undergoing total knee arthroplasty (TKA) and total hip arthroplasty (THA).DesignThis was a meta-analysis of randomised controlled trials (RCT) wherein the weighted mean difference (WMD) and relative risk (RR) were used for data synthesis applied in the random effects model. Stratified analyses based on the surgery type, region, intravenous and topical TXA dose and transfusion protocol were also conducted. The main outcomes included intraoperative and total blood loss volume, transfusion rate, low postoperative haemoglobin (Hb) level and postoperative Hb decline. However, the secondary outcomes included length of hospital stay (LOS) and/or occurrence of venous thromboembolism (VTE).SettingWe searched the PubMed, Embase and Cochrane CENTRAL databases for RCTs that compared different routes of TXA administration.ParticipantsPatients undergoing TKA or THA.InterventionsIntravenous, topical or combined intravenous and topical TXA.ResultsTwenty-six RCTs were selected, and the intravenous route did not differ substantially from the topical route with respect to the total blood loss volume (WMD=30.92, p=0.31), drain blood loss (WMD=-34.53, p=0.50), postoperative Hb levels (WMD=-0.01, p=0.96), Hb decline (WMD=-0.39, p=0.08), LOS (WMD=0.15, p=0.38), transfusion rate (RR=1.08, p=0.75) and VTE occurrence (RR=1.89, p=0.15). Compared with the combined-delivery group, the single-route group had significantly increased total blood loss volume (WMD=198.07, p<0.05), greater Hb decline (WMD=0.56, p<0.05) and higher transfusion rates (RR=2.51, p<0.05). However, no significant difference was noted in the drain blood loss, postoperative Hb levels and VTE events between the two groups. The intravenous and topical routes had comparable efficacy and safety profiles.ConclusionsThe combination of intravenous and topical TXA was relatively more effective in controlling bleeding without increased risk of VTE.

Project description:BackgroundA combined intravenous and intra-articular regimen is one of the most effective administration routes of tranexamic acid (TXA) to reduce perioperative blood loss in unilateral total knee arthroplasty. However, there have been few reports regarding use of the combined regimen for patients undergoing simultaneous bilateral total knee arthroplasty, in which blood-management strategy is more challenging.MethodsWe compared perioperative blood loss in 30 consecutive patients undergoing simultaneous bilateral total knee arthroplasty who received both 1,000 mg of TXA intravenously and 1,000 mg of intra-articular TXA in each knee (combined TXA group) with that in a consecutive series of 51 patients who only received 1,000 mg of TXA intravenously (intravenous TXA group). Additional intravenous TXA was administered 6 hours after the initial administration in both groups. Except for the intraoperative TXA administration regimen, an identical perioperative blood-management strategy was applied to both groups; this consisted of transfusion of 800 or 400 mL of predeposited autologous blood except for patients with a preoperative hemoglobin level of <11.0 g/dL, who received 4 units of allogenic blood. All surgical procedures were performed with spinal anesthesia and without use of a pneumatic tourniquet. Perioperative blood loss was calculated using the blood volume and change in hemoglobin level from the preoperative measurement to postoperative day 3.ResultsThere was significantly less perioperative blood loss in the combined TXA group compared with the intravenous TXA group (mean and standard deviation, 1,201 ± 347 versus 1,638 ± 400 mL, respectively; mean difference, 437 mL; 95% confidence interval, 263 to 613 mL; p < 0.0001). No patient in the combined TXA group and 1 patient (2%) in the intravenous TXA group required additional allogenic blood transfusion. No thrombotic events occurred in either group.ConclusionsIn a nonrandomized comparison, combined intra-articular and intravenous TXA significantly reduced the calculated perioperative blood loss in simultaneous bilateral total knee arthroplasty compared with that found in patients treated only with intravenous TXA.Level of evidenceTherapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Project description:ImportanceThe optimal pharmacologic thromboprophylaxis agent after total hip and total knee arthroplasty is uncertain and consensus is lacking. Quantifying the risk of postoperative venous thromboembolism (VTE) and bleeding and evaluating comparative effectiveness and safety of the thromboprophylaxis strategies can inform care.ObjectiveTo quantify risk factors for postoperative VTE and bleeding and compare patient outcomes among pharmacological thromboprophylaxis agents used after total hip and knee arthroplasty.Design, setting, and participantsThis retrospective cohort study used data from a large health care claims database. Participants included patients in the United States with hip or knee arthroplasty and continuous insurance enrollment 3 months prior to and following their surgical procedure. Patients were excluded if they received anticoagulation before surgery, received no postsurgical pharmacological thromboprophylaxis, or had multiple postsurgery thromboprophylactic agents. In a propensity-matched analysis, patients receiving a direct oral anticoagulant (DOAC) were matched with those receiving aspirin.ExposuresAspirin, apixaban, rivaroxaban, enoxaparin, or warfarin.Main outcomes and measuresThe primary outcome was 30-day cumulative incidence of postdischarge VTE. Other outcomes included postdischarge bleeding.ResultsAmong 29 264 patients included in the final cohort, 17 040 (58.2%) were female, 27 897 (95.2%) had inpatient admissions with median (IQR) length of stay of 2 (1-2) days, 10 948 (37.4%) underwent total hip arthroplasty, 18 316 (62.6%) underwent total knee arthroplasty; and median (IQR) age was 59 (55-63) years. At 30 days, cumulative incidence of VTE was 1.19% (95% CI, 1.06%-1.32%) and cumulative incidence of bleeding was 3.43% (95% CI, 3.22%-3.64%). In the multivariate analysis, leading risk factors associated with increased VTE risk included prior VTE history (odds ratio [OR], 5.94 [95% CI, 4.29-8.24]), a hereditary hypercoagulable state (OR, 2.64 [95% CI, 1.32-5.28]), knee arthroplasty (OR, 1.65 [95% CI, 1.29-2.10]), and male sex (OR, 1.34 [95% CI, 1.08-1.67]). In a propensity-matched cohort of 7844 DOAC-aspirin pairs, there was no significant difference in the risk of VTE in the first 30 days after the surgical procedure (OR, 1.14 [95% CI, 0.82-1.59]), but postoperative bleeding was more frequent in patients receiving DOACs (OR, 1.36 [95% CI, 1.13-1.62]).Conclusions and relevanceIn this cohort study of patients who underwent total hip or total knee arthroplasty, underlying patient risk factors, but not choice of aspirin or DOAC, were associated with postsurgical VTE. Postoperative bleeding rates were lower in patients prescribed aspirin. These results suggest that thromboprophylaxis strategies should be patient-centric and tailored to individual risk of thrombosis and bleeding.

Project description:ObjectiveTo determine the effectiveness and safety of perioperative tranexamic acid use in patients undergoing total hip or knee arthroplasty in the United States.DesignRetrospective cohort study; multilevel multivariable logistic regression models measured the association between tranexamic acid use in the perioperative period and outcomes.Setting510 US hospitals from the claims based Premier Perspective database for 2006-12.Participants872,416 patients who had total hip or knee arthroplasty.InterventionPerioperative intravenous tranexamic acid use by dose categories (none, ≤ 1000 mg, 2000 mg, and ≥ 3000 mg).Main outcome measuresAllogeneic or autologous transfusion, thromboembolic complications (pulmonary embolism, deep venous thrombosis), acute renal failure, and combined complications (thromboembolic complications, acute renal failure, cerebrovascular events, myocardial infarction, in-hospital mortality).ResultsWhile comparable regarding average age and comorbidity index, patients receiving tranexamic acid (versus those who did not) showed lower rates of allogeneic or autologous transfusion (7.7% v 20.1%), thromboembolic complications (0.6% v 0.8%), acute renal failure (1.2% v 1.6%), and combined complications (1.9% v 2.6%); all P<0.01. In the multilevel models, tranexamic acid dose categories (versus no tranexamic acid use) were associated with significantly (P<0.001) decreased odds for allogeneic or autologous blood transfusions (odds ratio 0.31 to 0.38 by dose category) and no significantly increased risk for complications: thromboembolic complications (odds ratio 0.85 to 1.02), acute renal failure (0.70 to 1.11), and combined complications (0.75 to 0.98).ConclusionsTranexamic acid was effective in reducing the need for blood transfusions while not increasing the risk of complications, including thromboembolic events and renal failure. Thus our data provide incremental evidence of the potential effectiveness and safety of tranexamic acid in patients requiring orthopedic surgery.

Dataset Information

Effectiveness of oral versus intravenous tranexamic acid in primary total hip and knee arthroplasty: a randomised, non-inferiority trial.

Background

Methods

Results

Conclusions

Publications

Effectiveness of oral versus intravenous tranexamic acid in primary total hip and knee arthroplasty: a randomised, non-inferiority trial.

Similar Datasets

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