Tranexamic Acid versus Placebo to Prevent Blood Transfusion during Radical Cystectomy for Bladder Cancer (TACT): Study Protocol for a Randomized Controlled Trial

Trials

Alexis Turgeon¹  Ryan Zarychanski²  Greg Knoll³  Ilias Cagiannos³  Christopher Morash³  Franco Momoli⁴  Gregory Bryson⁴  Dean A. Fergusson⁴  Rodney H. Breau⁴  Ranjeeta Mallick⁴  Luke T. Lavallée⁴  Salmaan Kanji⁴  Kelsey Witiuk⁴  Sonya Cnossen⁴ 

[1] CHU de Québec, Université Laval;Department of Internal Medicine, Section of Medical Oncology and Haematology, University of Manitoba;Division of Urology, Department of Surgery, The Ottawa Hospital;Ottawa Hospital Research Institute;

关键词: Bladder cancer;    Radical cystectomy;    Tranexamic acid;    Blood transfusion;   

DOI  :  10.1186/s13063-018-2626-3

来源: DOAJ

【 摘 要 】

Abstract Background Radical cystectomy for bladder cancer is associated with a high risk of needing red blood cell transfusion. Tranexamic acid reduces blood loss during cardiac and orthopedic surgery, but no study has yet evaluated tranexamic acid use during cystectomy. Methods A randomized, double-blind (surgeon-, anesthesiologist-, patient-, data-monitor-blinded), placebo-controlled trial of tranexamic acid during cystectomy was initiated in June 2013. Prior to incision, the intervention arm participants receive a 10 mg/kg loading dose of intravenously administered tranexamic acid, followed by a 5 mg/kg/h maintenance infusion. In the control arm, the patient receives an identical volume of normal saline that is indistinguishable from the intervention. The primary outcome is any blood transfusion from the start of surgery up to 30 days post operative. There are no strict criteria to mandate the transfusion of blood products. The decision to transfuse is entirely at the discretion of the treating physicians who are blinded to patient allocation. Physicians are allowed to utilize all resources to make transfusion decisions, including serum hemoglobin concentration and vital signs. To date, 147 patients of a planned 354 have been randomized to the study. Discussion This protocol reviews pertinent data relating to blood transfusion during radical cystectomy, highlighting the need to identify methods for reducing blood loss and preventing transfusion in patients receiving radical cystectomy. It explains the clinical rationale for using tranexamic acid to reduce blood loss during cystectomy, and outlines the study methods of our ongoing randomized controlled trial. Trial registrations Canadian Institute for Health Research (CIHR) Protocol: MOP-342559; ClinicalTrials.gov, ID: NCT01869413. Registered on 5 June 2013.

【 授权许可】

Unknown