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Intravenous tranexamic acid and lower limb arthroplasty-a randomised controlled feasibility study.
Painter, T W; Daly, D J; Kluger, R; Rutherford, A; Ditoro, A; Grant, C; Howell, S.
Afiliación
  • Painter TW; Clinical Senior Lecturer, Discipline of Acute Care Medicine, Adelaide Medical School, University of Adelaide; Adelaide, South Australia.
  • Daly DJ; Staff Anaesthetist, Department of Anaesthesia and Perioperative Medicine, Alfred Hospital; Clinical Senior Lecturer, Monash University; Melbourne, Victoria.
  • Kluger R; Senior Staff Anaesthetist, Department of Anaesthesia and Acute Pain Medicine, St. Vincent's Hospital, Melbourne, Victoria.
  • Rutherford A; Research nurse, Pain and Anaesthesia Research Centre, Discipline of Acute Care Medicine, Adelaide Medical School, The University of Adelaide, Adelaide, South Australia.
  • Ditoro A; Research Nurse, Department of Anaesthesia and Perioperative Medicine, Alfred Hospital, Alfred Hospital, Victoria.
  • Grant C; Research Associate, Discipline of Acute Care Medicine, Adelaide Medical School, The University of Adelaide, Adelaide, South Australia.
  • Howell S; Senior Statistician, Data Design and Statistics Service, Adelaide Health Technology Assessment, School of Public Health, The University of Adelaide, Adelaide, South Australia.
Anaesth Intensive Care ; 46(4): 386-395, 2018 Jul.
Article en En | MEDLINE | ID: mdl-29966112
Tranexamic acid (TA) is widely reported to reduce bleeding and the risk of blood transfusion in patients undergoing lower limb arthroplasty. No study in this setting has had adequate power to examine for the effect of TA on either uncommon, but clinically important, adverse events or patient-centric endpoints. A large randomised controlled trial (RCT) is required to address these questions. As a preliminary feasibility study, we conducted an investigator-initiated, prospective, randomised, double blind placebo-controlled trial in 140 patients, aged 45 years or older, undergoing elective primary or revision hip or knee joint replacement. Subjects were randomised to receive intravenous (IV) TA or a placebo. The primary endpoints were the proportion of patients receiving allogenic blood transfusion and the feasibility of extending our trial methodology to a large trial of TA in this population. Secondary endpoints included a range of adverse clinical and surgical events as well as several patient-centric questionnaires. Red blood cell transfusion occurred in 15% of all patients prior to discharge from hospital. Transfusion rates were significantly different between the TA and placebo groups (8.5% versus 21.7%, P=0.03). Three out of four feasibility endpoints were met, with recruitment being slower than expected. No significant differences were seen between groups in the secondary endpoints. Despite a lower rate of transfusion than that widely reported, IV TA reduced transfusion in patients undergoing lower limb arthroplasty. Our trial methodology would be feasible in the setting of a large multicentre study to investigate whether TA is safe and reduces bleeding in lower limb arthroplasty.
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Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Artroplastia / Ácido Tranexámico / Extremidad Inferior / Antifibrinolíticos Tipo de estudio: Clinical_trials / Observational_studies / Risk_factors_studies Aspecto: Patient_preference Límite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Anaesth Intensive Care Año: 2018 Tipo del documento: Article Pais de publicación: Estados Unidos
Buscar en Google
Añadir a Mi BVS
Imprimir
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PubMed Links

Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Artroplastia / Ácido Tranexámico / Extremidad Inferior / Antifibrinolíticos Tipo de estudio: Clinical_trials / Observational_studies / Risk_factors_studies Aspecto: Patient_preference Límite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Anaesth Intensive Care Año: 2018 Tipo del documento: Article Pais de publicación: Estados Unidos