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

Antonella Crescenti, Giovanni Borghi, Elena Bignami, Gaia Bertarelli, Giovanni Landoni, Giuseppina Maria Casiraghi, Alberto Briganti, Francesco Montorsi, Patrizio Rigatti, Alberto Zangrillo, Antonella Crescenti, Giovanni Borghi, Elena Bignami, Gaia Bertarelli, Giovanni Landoni, Giuseppina Maria Casiraghi, Alberto Briganti, Francesco Montorsi, Patrizio Rigatti, Alberto Zangrillo

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.

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.

Conflict of interest statement

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.

Figures

https://www.ncbi.nlm.nih.gov/pmc/articles/instance/4788338/bin/crea876466.f1_default.jpg
Fig 1 Trial profile
https://www.ncbi.nlm.nih.gov/pmc/articles/instance/4788338/bin/crea876466.f2_default.jpg
Fig 2 Preoperative, intraoperative, and postoperative concentrations of haemoglobin in intervention and control groups

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Source: PubMed

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