RESUMEN
BACKGROUND: The application of tranexamic acid (TXA) in total hip arthroplasty (THA) and total knee arthroplasty (TKA) has brought momentous changes in blood management. However, the optimal regimen of TXA has not yet been identified. This study aimed to compare the efficacy of a three-day prolonged-course of multiple-dose of TXA with a single pre-operative dose of TXA in patients who undergo THA and TKA. METHOD: We retrospectively analyzed two groups of consecutive patients who received primary unilateral THA and TKA from 2015 to 2017. One group received a three-day prolonged-course of multiple-dose of TXA, while another group received a single-dose of TXA. The primary outcomes included the changes in hemoglobin (Hb), estimated total blood loss (TBL), and transfusion rate; the secondary outcomes included the platelet (PLT) counts, inflammatory markers, and fibrinolysis parameters. RESULTS: A total of 193 THA and 166 TKA procedures were included for comparison. Compared with the patients who received a single-dose of TXA, the patients who received a three-day prolonged-course of multiple-dose of TXA had smaller post-operative drops in Hb levels, which led to consistently significantly higher Hb levels in both THA and TKA. Therefore, the use of multiple-dose of TXA was associated with significantly lower maximum Hb drops and estimated TBL in both THA (24.58±11.43 vs. 30.38±11.33 g/L, P=0.001; 685.88±412.02 vs. 968.94±479.9 mL, P<0.0001) and TKA (18.04±9.75 vs. 27.24±10.99 g/L, P<0.0001; 497.35±291.03 vs. 816.51±354.38 mL, P<0.0001), and marginally reduced transfusion requirements (THA: 1/65 vs. 10/128; TKA: 0/70 vs. 2/96). The multiple-dose group also showed higher PLT counts, continuously reduced inflammatory responses, and significantly and durably attenuated fibrinolytic responses. CONCLUSIONS: A three-day prolonged-course of multiple-dose of TXA was consistently effective in reducing post-operative Hb drops, estimated TBL, inflammatory responses, and fibrinolytic responses, which could be recommended for clinical practice. However, these findings need to be confirmed by prospective studies.
RESUMEN
BACKGROUND: Questions remain, mainly concerning whether tranexamic acid (TXA) is truly safe since all available trials were underpowered to identify clinically important differences. The objective of this study is to evaluate the safety of TXA by using a novel technique-thromboelastography (TEG). METHODS: A retrospective review was conducted on 359 consecutive patients who underwent primary total hip arthroplasty (THA) or total knee arthroplasty (TKA) and received multiple-dose or single-dose of TXA at a tertiary academic center. TEG parameters, TEG coagulation status, conventional coagulation test parameters, and incidence of thrombotic events were used for safety evaluation. RESULTS: Compared with single-dose cohort, patients who received multiple-dose of TXA had consistent statistically significant shortened R times on post-operative day 1 (POD1) and POD3 in both THA (POD1: 4.06 ± 0.71 s versus 4.45 ± 1.28 s, P = 0.011; POD3: 4.36 ± 0.83 s versus 5.12 ± 1.64 s, P < 0.0001) and TKA (POD1: 3.90 ± 0.73 s versus 4.29 ± 0.92 s, P = 0.011; POD3: 4.24 ± 0.94 s versus 4.65 ± 1.07 s, P = 0.023), while the K, α-angle, and MA values were similar during the perioperative period. TEG coagulation status analysis indicated that patients were significantly (P = 0.003) more likely with hypercoagulable status during the course of multiple-dose TXA. Conventional coagulation test parameters were similar. Only one patient developed calf vein thrombosis in the multiple-dose cohort. CONCLUSIONS: Multiple-dose of TXA was associated with aggravated hypercoagulable state when compared with single-dose of TXA, but this prothrombotic state does not provoke thrombosis when combined with appropriate anticoagulant therapy. Therefore, multiple-dose of TXA remains safe and could be recommended for clinical practice. Potential benefits and possible risks should be trade-off when considering increasing the dosage and frequency of TXA on the present basis. TRIAL REGISTRATION: ChiCTR1800015422 .
Asunto(s)
Antifibrinolíticos/administración & dosificación , Artroplastia de Reemplazo de Cadera/tendencias , Artroplastia de Reemplazo de Rodilla/tendencias , Tromboelastografía/métodos , Ácido Tranexámico/administración & dosificación , Anciano , Anciano de 80 o más Años , Anticoagulantes/administración & dosificación , Antifibrinolíticos/efectos adversos , Artroplastia de Reemplazo de Cadera/efectos adversos , Artroplastia de Reemplazo de Rodilla/efectos adversos , Estudios de Cohortes , Relación Dosis-Respuesta a Droga , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Trombosis/inducido químicamente , Trombosis/prevención & control , Ácido Tranexámico/efectos adversosRESUMEN
INTRODUCTION: Current total hip arthroplasty (THA) implant usage trends favor cementless fixation, and plenty studies have demonstrated that numbers of cementless femoral stems are associated with excellent long-term survivorship and functional outcomes. Various types of cementless femoral stems have been developed and utilized in multiple applications, including straight, tapered, anatomic, customized, short, and even neck stems. All of these designs aimed to achieve maximal primary stability and promote osseointegration. Nevertheless, stress-shielding and periprosthetic bone loss continue to occur and remain critical issues in promoting long-term survivorship of THA. Considering anatomic and tapered stems are the most popular cementless designs today, this prospective cohort study aimed to investigate the effect of stem design on stress-shielding and periprosthetic bone remodeling after implantation of an anatomic stem with proximal fixation (Ribbed Hip system; Waldemar Link, Hamburg, Germany) and the direct comparison to a fully coated tapered stem (LCU Hip system; Waldemar Link). MATERIALS AND METHODS: This prospective cohort study will comprise patients who receive primary unilateral THA with the Ribbed anatomic hydroxyapatite (HA)-coated stem or LCU tapered fully HA-coated stem. The changes in periprosthetic bone mineral density after insertion of Ribbed and LCU stem prostheses will be assessed by means of dual-energy X-ray absorptiometry in the periprosthetic region of interest according to Gruen and colleagues. Standard anteroposterior and lateral plain radiography will be performed for qualitative assessment of the periprosthetic bone remodeling. The following items will be analyzed or measured on follow-up radiographs to compare with the initial appearance on the radiographs taken immediately postoperatively: cortical thickness in each Gruen zone, fitness of the distal stem within the isthmus, femoral stem alignment, radiolucent line, reactive line, periosteal bone reactions, and subsidence. Biologic fixation and stability of the cementless implant will be evaluated using Engh grading scale, and heterotopic ossification will be graded according to Brooker classification. Furthermore, Harris hip score and Western Ontario and McMaster Universities Osteoarthritis Index Score will also be assessed for postoperative functional evaluation. These radiologic and clinical assessments will be taken postoperatively, at 6 months, 1, 2, 3, 4, and 5 years after surgery. ETHICS AND DISSEMINATION: This study was approved by The First Affiliated Hospital of Chongqing Medical University Ethics Committee. The study results will be disseminated at national and international conferences and published in peer-reviewed journals. STUDY REGISTRATION: Chinese Clinical Trial Registry (http://www.chictr.org.cn): ChiCTR1800017841.