Tranexamic acid and blood loss in pancreaticoduodenectomy: TAC-PD randomized clinical trial

Division of Surgical Oncology, Department of Surgery, Nagoya University Graduate School of Medicine, Nagoya, Aichi, Japan. Department of General Surgery, Toyohashi Municipal Hospital, Toyohashi, Aichi, Japan. Division of Perioperative Medicine, Department of Surgery, Nagoya University Graduate School of Medicine, Nagoya, Aichi, Japan. Department of Advanced Medicine, Nagoya University Hospital, Nagoya, Aichi, Japan. Department of Gastroenterological Surgery, Aichi Cancer Centre Hospital, Nagoya, Aichi, Japan. Department of Surgery, Toyota Kosei Hospital, Toyota, Aichi, Japan. Department of Surgery, Ogaki Municipal Hospital, Ogaki, Gifu, Japan. Department of Surgery, Kasugai Municipal Hospital, Kasugai, Aichi, Japan.

The British journal of surgery. 2022

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Abstract
BACKGROUND Tranexamic acid (TXA) may reduce intraoperative blood loss, but it has not been investigated in pancreaticoduodenectomy (PD). METHODS A pragmatic, multicentre, randomized, blinded, placebo-controlled trial was conducted. Adult patients undergoing planned PD for biliary, duodenal, or pancreatic diseases were randomly assigned to TXA or placebo groups. Patients in the TXA group were administered 1 g TXA before incision, followed by a maintenance infusion of 125 mg/h TXA. Patients in the placebo group were administered the same volume of saline as those in the placebo group. The primary outcome was blood loss during PD. The secondary outcomes included perioperative blood transfusions, operating time, morbidity, and mortality. RESULTS Between September 2019 and May 2021, 218 patients were randomly assigned and underwent surgery (108 in the TXA group and 110 in the placebo group). Mean intraoperative blood loss was 659 ml in the TXA group and 701 ml in the placebo group (mean difference -42 ml, 95 per cent c.i. -191 to 106). Of the 218 patients, 202 received the intervention and underwent PD, and the mean blood loss during PD was 667 ml in the TXA group and 744 ml in the placebo group (mean difference -77 ml, 95 per cent c.i. -226 to 72). The secondary outcomes were comparable between the two groups. CONCLUSION Perioperative TXA use did not reduce blood loss during PD. REGISTRATION NUMBER jRCTs041190062 (https://jrct.niph.go.jp).
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Language : eng
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