Intraoperative use of tranexamic acid to reduce transfusion rate in patients undergoing radical retropubic prostatectomy: double blind, randomised, placebo controlled trial

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Antonella Crescenti, anaesthetist1,
Giovanni Borghi, medical doctor1,
Elena Bignami, anaesthetist, junior research executive1,
Gaia Bertarelli, statistician1,
Giovanni Landoni, anaesthetist, senior research executive1,
Giuseppina Maria Casiraghi, anaesthetist1,
Alberto Briganti, urologist, senior research executive2,
Francesco Montorsi, professor of urology2,
Patrizio Rigatti, professor of urology2,
Alberto Zangrillo, professor of anaesthesiology and intensive care1

¹Department of Anaesthesia and Intensive Care, Vita-Salute San Raffaele University, Milan, 20132, Italy
²Department of Urology, Vita-Salute San Raffaele University

Correspondence to: G Landoni landoni.giovanni{at}hsr.it

Accepted 7 August 2011

Abstract

Objectives To determine the efficacy of intraoperative treatment with low dose tranexamic acid in reducing the rate of perioperative transfusions in patients undergoing radical retropubic prostatectomy.

Design Double blind, parallel group, randomised, placebo controlled trial.

Setting One university hospital in Milan, Italy.

Participants 200 patients older than 18 years and undergoing radical retropubic prostatectomy agreed to participate in the trial. Exclusion criteria were atrial fibrillation, coronary artery disease treated with drug eluting stent, severe chronic renal failure, congenital or acquired thrombophilia, and known or suspected allergy to tranexamic acid.

Interventions Intravenous infusion of tranexamic acid or equivalent volume of placebo (saline) according to the following protocol: loading dose of 500 mg tranexamic acid 20 minutes before surgery followed by continuous infusion of tranexamic acid at 250 mg/h during surgery.

Main outcome measures Primary outcome: number of patients receiving blood transfusions perioperatively. Secondary outcome: intraoperative blood loss. Six month follow-up to assess long term safety in terms of mortality and thromboembolic events.

Results All patients completed treatment and none was lost to follow-up. Patients transfused were 34 (34%) in the tranexamic acid group and 55 (55%) in the control group (absolute reduction in transfusion rate 21% (95% CI 7% to 34%); relative risk of receiving transfusions for patients treated with tranexamic acid 0.62 (0.45 to 0.85); number needed to treat 5 (3 to 14); P=0.004). At follow-up, no patients died and the occurrence of thromboembolic events did not differ between the two groups.

Conclusions Intraoperative treatment with low dose tranexamic acid is safe and effective in reducing the rate of perioperative blood transfusions in patients undergoing radical retropubic prostatectomy.

Trial registration ClinicalTrials.gov identifier NCT00670345.

Footnotes

Contributors: All authors took part in all stages of the study, from design to writing and editing the manuscript. AC, AB, and EB participated in patient recruitment and undertaking of the study. GMC undertook perioperative management during the study and monitored patients. AZ, PR, and FM participated in the design of the study. GB did the data analysis and interpretation, and GL and GB wrote the manuscript. All authors had full access to all of the data in the study (including statistical reports and tables) and are responsible for the integrity of the data and the accuracy of the analysis. GL is the guarantor of the study.
Funding: Provided by the Department of Anaesthesia and Intensive Care of San Raffaele Hospital.
Competing interests: All authors have completed the unified competing interest form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: the study was funded by the Department of Anaesthesia and Intensive Care of San Raffaele Hospital; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.
Ethical approval: The study was approved by the ethics committee at the San Raffaele Hospital.
Patient consent: We received written informed consent for trial inclusion. Although we did not obtain informed consent for data sharing, the presented data were anonymised with a low risk of identification.
Data sharing: Dataset available from GL.

This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/2.0/ and http://creativecommons.org/licenses/by-nc/2.0/legalcode.