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Efficacy of low-dose intra-articular tranexamic acid in total knee replacement; a prospective triple-blinded randomized controlled trial.

ABSTRACT: Recently, a number of studies using intra-articular application of tranexamic acid (IA-TXA), with different dosage and techniques, successfully reduced postoperative blood loss in total knee replacement (TKR). However, best of our knowledge, the very low dose of IA-TXA with drain clamping technique in conventional TKR has not been yet studied. This study aimed to evaluate the effectiveness and dose-response effect of two low-dose IA-TXA regimens in conventional TKR on blood loss and blood transfusion reduction.Between 2010 and 2011, a triple-blinded randomized controlled study was conducted in 135 patients undergoing conventional TKR. The patients were allocated into three groups according to intra-articular solution received: Control group (physiologic saline), TXA-250 group (TXA 250 mg), and TXA-500 group (TXA 500 mg). The solution was injected after wound closure followed by drain clamping for 2 hours. Blood loss and transfusion were recorded. Duplex ultrasound was performed. Functional outcome and complication were followed for one year.There were forty-five patients per groups. The mean total hemoglobin loss was 2.9 g/dL in control group compared with 2.2 g/dL in both TXA groups (p?>?0.001). Ten patients (22%, control), six patients (13%, TXA-250) and none (TXA-500) required transfusion (p?=?0.005). Thromboembolic events were detected in 7 patients (4 controls, 1 TXA-250, and 2 TXA-500). Functional outcome was non-significant difference between groups.Combined low-dose IA-TXA, as 500 mg, with 2-hour clamp drain is effective for reducing postoperative blood loss and transfusion in conventional TKR without significant difference in postoperative knee function or complication.ClinicalTrials.gov NCT01850394.

SUBMITTER: Sa-Ngasoongsong P

PROVIDER: S-EPMC4234192 | biostudies-literature | 2013 Dec

REPOSITORIES: biostudies-literature

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Efficacy of low-dose intra-articular tranexamic acid in total knee replacement; a prospective triple-blinded randomized controlled trial.

Sa-Ngasoongsong Paphon P Wongsak Siwadol S Chanplakorn Pongsthorn P Woratanarat Patarawan P Wechmongkolgorn Supaporn S Wibulpolprasert Bussanee B Mulpruek Pornchai P Kawinwonggowit Viroj V

BMC musculoskeletal disorders 20131205

<h4>Background</h4>Recently, a number of studies using intra-articular application of tranexamic acid (IA-TXA), with different dosage and techniques, successfully reduced postoperative blood loss in total knee replacement (TKR). However, best of our knowledge, the very low dose of IA-TXA with drain clamping technique in conventional TKR has not been yet studied. This study aimed to evaluate the effectiveness and dose-response effect of two low-dose IA-TXA regimens in conventional TKR on blood lo ...[more]

PMID: 24308672

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Project description:BackgroundThe increasing demand for total knee arthroplasty (TKR) and the initiatives to reduce health care spending have put the responsibility for efficient care on hospitals and providers. Multidisciplinary care pathways have been shown to shorten length of stay and result in improved short-term outcomes. However, common problems such as post-op nausea, orthostasis, and quad weakness remain, while reliance on discharge to rehabilitation facilities may also prolong hospital stay.Questions/purposesOur aim was to document that combined modifications of our traditional clinical pathway for unilateral TKR could lead to improved short-term outcomes. We pose the following research questions. Can pathway modifications which include intra-articular infusion and saphenous nerve block (SNB) provide adequate pain relief and eliminate common side effects promoting earlier mobilization? Can planning for discharge to home avoid in-patient rehab stays? Can these combined modifications decrease length of stay even in patients with complex comorbidities indicated by higher ASA class? Will discharge to home incur an increase in complications or a failure to achieve knee range of motion?Patients and methodsA retrospective review was performed and identified two cohorts. Group A included 116 patients that underwent unilateral TKR for osteoarthritis between August 2009 and August 2010. Group B included 171 patients that underwent unilateral TKR for osteoarthritis between February 2012 to February 2013. Group A patients were treated with spinal anesthesia with patient-controlled epidural analgesia (PCEA)/femoral nerve block (FNB) for the first 48 h after surgery. Discharge planning was initiated after admission. Group B had spinal anesthesia with SNB and received a continuous intra-articular infusion of 0.2% ropivicaine for 48 h post-op. Discharge planning was initiated with a case manager prior to hospitalization and discharge to home was declared the preferred approach. An intensive home PT program was made available through a program with our local home care agency. Outcomes assessed and compared between groups included length of stay, incidence of post-op nausea, dizziness, in-hospital falls, occurrence of complications including wound infection and the recovery of range of motion at 6 weeks, 3 months, and 1 year post-op.ResultsPain control was similar between the groups but Group B had fewer side effects. With the new pathway, length of stay (LOS) was reduced from 4.32 to 3.64 days with a similar LOS reduction across all ASA classes. There was no increase in Group B wound or other complications. Return of ROM was similar between groups.ConclusionsOur findings suggest that replacing PCEA and FNB with intra-articular analgesia with a SNB allows for improved early recovery following TKR. That, combined with pre-op discharge planning and initiation of an intensive home PT program, reduced average length of stay.

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:OBJECTIVES:This study aimed to describe patients treated for knee osteoarthritis between 2006 and 2013 in France and to compare the delay from diagnosis to total knee replacement between patients who received intra-articular hyaluronic acid injections and those who did not receive the injections. A second objective was to compare direct medical costs for ambulatory care between treatment groups. MATERIALS AND METHODS:Patients were selected from a representative sample of the real world administrative claims database using an algorithm developed by experts from the scientific committee of the study. Data were matched with the medico-administrative database for hospital care. A Cox proportional hazards model was stratified for the treatment group and adjusted for available socio-demographic and medical covariates to compare restricted mean survival times at different time points (1, 3, 5 and 7.5 years) between groups. Costs were expressed in 2013 euros. RESULTS:A total of 14,782 patients were treated for knee osteoarthritis (67% women; mean age = 68 years). Among this population, 1,662 patients had total knee replacement (11.2%). At each time point, restricted mean survival time without total knee replacement was significantly higher (p-values<0.001) for hyaluronic acid group, from +51 to +217 days at 1 and 7.5 years, respectively. For the year preceding total knee replacement, the means for total direct medical costs were similar between groups, €744 vs €805 for treatment and control groups, respectively, (p-value = 0.104). Intra-articular injections accounted for less than 10% of the total costs. CONCLUSION:This is the first retrospective longitudinal study involving knee osteoarthritis patients using medico-administrative databases in France. The results support the effectiveness of hyaluronic acid injections in delaying total knee replacement and show that patients treated with hyaluronic acid have similar direct medical costs for ambulatory care compared to patients treated with corticosteroids only.

Project description:BACKGROUND:Tranexamic acid (TXA) is an antifibrinolytic drug. Topical administration of TXA during total knee arthroplasty (TKA) is favored for certain patients because of concerns about thrombotic complications, despite a lack of supporting literature. We compared local and systemic levels of thrombogenic markers, interleukin (IL)-6, and TXA between patients who received intravenous (IV) TXA and those who received topical TXA. METHODS:Seventy-six patients scheduled for TKA were enrolled in this randomized double-blinded study. The IV group received 1.0 g of IV TXA before tourniquet inflation and again 3 hours later; a topical placebo was administered 5 minutes before final tourniquet release. The topical group received an IV placebo before tourniquet inflation and again 3 hours later; 3.0 g of TXA was administered topically 5 minutes before final tourniquet release. Peripheral and wound blood samples were collected to measure levels of plasmin-anti-plasmin (PAP, a measure of fibrinolysis), prothrombin fragment 1.2 (PF1.2, a marker of thrombin generation), IL-6, and TXA. RESULTS:At 1 hour after tourniquet release, systemic PAP levels were comparable between the IV group (after a single dose of IV TXA) and the topical group. At 4 hours after tourniquet release, the IV group had lower systemic PAP levels than the topical group (mean and standard deviation, 1,117.8 ± 478.9 µg/L versus 1,280.7 ± 646.5 µg/L; p = 0.049), indicative of higher antifibrinolytic activity after the second dose. There was no difference in PF1.2 levels between groups, indicating that there was no increase in thrombin generation. The IV group had higher TXA levels at all time points (p < 0.001). Four hours after tourniquet release, wound blood IL-6 and TXA levels were higher than systemic levels in both groups (p < 0.001). Therapeutic systemic TXA levels (mean, 7.2 ± 7.4 mg/L) were noted in the topical group. Calculated blood loss and the length of the hospital stay were lower in the IV group (p = 0.026 and p = 0.025). CONCLUSIONS:Given that therapeutic levels were reached with topical TXA and the lack of a major difference in the mechanism of action, coagulation, and fibrinolytic profile between topical TXA and a single dose of IV TXA, it may be a simpler protocol for institutions to adopt the use of a single dose of IV TXA when safety is a concern. LEVEL OF EVIDENCE:Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Dataset Information

Efficacy of low-dose intra-articular tranexamic acid in total knee replacement; a prospective triple-blinded randomized controlled trial.

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Efficacy of low-dose intra-articular tranexamic acid in total knee replacement; a prospective triple-blinded randomized controlled trial.

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