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

Simple item page
dc.contributor.authorBreau, Rodney H
dc.contributor.authorLavallée, Luke T
dc.contributor.authorCnossen, Sonya
dc.contributor.authorWitiuk, Kelsey
dc.contributor.authorCagiannos, Ilias
dc.contributor.authorMomoli, Franco
dc.contributor.authorBryson, Gregory
dc.contributor.authorKanji, Salmaan
dc.contributor.authorMorash, Christopher
dc.contributor.authorTurgeon, Alexis
dc.contributor.authorZarychanski, Ryan
dc.contributor.authorMallick, Ranjeeta
dc.contributor.authorKnoll, Greg
dc.contributor.authorFergusson, Dean A
dc.date.accessioned2018-06-01T11:42:00Z
dc.date.issued2018-05-02
dc.date.updated2018-06-01T11:42:01Z
dc.description.abstractAbstract 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.
dc.identifier.citationTrials. 2018 May 02;19(1):261
dc.identifier.urihttps://doi.org/10.1186/s13063-018-2626-3
dc.identifier.urihttp://hdl.handle.net/1993/33044
dc.language.rfc3066en
dc.rightsopen accessen_US
dc.rights.holderThe Author(s).
dc.titleTranexamic Acid versus Placebo to Prevent Blood Transfusion during Radical Cystectomy for Bladder Cancer (TACT): Study Protocol for a Randomized Controlled Trial
dc.typeJournal Article
Files
Original bundle
Now showing 1 - 1 of 1
Thumbnail Image
Name:
13063_2018_Article_2626.pdf
Size:
875.89 KB
Format:
Adobe Portable Document Format
Description:
Download
License bundle
Now showing 1 - 1 of 1
Thumbnail Image
Name:
license.txt
Size:
2.24 KB
Format:
Item-specific license agreed to upon submission
Description:
Download
Collections
University of Manitoba Scholarship
Rady Faculty of Health Sciences Scholarly Works