Tranexamic acid and blood loss in pancreaticoduodenectomy: TAC-PD randomized clinical trial
Ishii K, Yokoyama Y, Yonekawa Y, Hayashi D, Kinoshita F, Kuwatsuka Y, Okuno M, Natsume S, Minami T, Sugawara G, et al
The British journal of surgery. 2022
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).
Efficacy and safety associated with the infusion speed of intravenous immunoglobulin for the treatment of Kawasaki disease: a randomized controlled trial
Fukui S, Seki M, Minami T, Kotani K, Oka K, Yokomizo A, Matsubara D, Sato T, Nozaki Y, Saito M, et al
Pediatric rheumatology online journal. 2021;19(1):107
BACKGROUND High-dose intravenous immunoglobulin (IVIG) is the mainstay of treatment for Kawasaki disease (KD). Usually, 2 g/kg of IVIG is administered over 10-24 h, depending on the institution or physician, but the association between infusion speed and effectiveness has not been reported. In this study, we evaluated the differences in efficacy and safety between two different IVIG administration speeds. METHODS This was a multicenter, unblinded, randomized controlled study. Patients newly diagnosed with KD were randomized into two groups: one who received IVIG over 12 h (12H group, double speed), and one that received IVIG over 24 h (24H group, reference speed). The endpoints included the duration of fever, incidence of coronary artery abnormalities (CAAs) and of adverse events. Laboratory data were evaluated before and after IVIG administration. RESULTS A total of 39 patients were enrolled. There was no difference between groups in fever duration after the initiation of IVIG (21 h vs. 21.5 h, p = 0.325), and no patient experienced CAAs. Two adverse events were observed in the 12H group (elevation of aspartate aminotransferase and vomiting), however no severe adverse events requiring treatments or extension of hospital stay were observed in either group. After initial IVIG administration, the change ratio of inflammatory markers, such as white blood cell counts, neutrophils, C-reactive protein, and albumin, did not show significant differences between the two groups. On the other hand, a greater increase of serum immunoglobulin G from its baseline level was observed in the 24H group compared to the 12H group (3037 ± 648 mg/dl vs. 2414 ± 248 mg/dl, p < 0.01). CONCLUSION The efficacy and safety of IVIG administered over 12 h (double speed) were similar to those administered over 24 h (reference speed). TRIAL REGISTRATION University Hospital Medical Information Network ( UMIN000014665 ). Registered 27 July 2014 - Prospectively registered, https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000017058.
Comparison of effectiveness of the piston-pump method versus the pressure-infusor method for rapid infusion of crystalloids: A bench study
Hashimoto W, Takenaka I, Yasunami K, Minami T, Sano H
Indian journal of anaesthesia. 2020;64(12):1059-1063
BACKGROUND AND AIMS The piston-pump method is a simple method for rapid administration of fluids but some problems are unsolved. We compared the effectiveness of using the piston-pump method with that of the pressure-infusor method. METHODS Twelve anaesthetists were classified randomly into the piston-pump and pressure-infusor groups. They were asked to infuse 500 ml of saline three times successively through a 16-G intravenous cannula as rapidly as possible using a pump with a 50-ml syringe or a pressure-infusor at 300 mmHg. The time taken for infusion and the maximum or minimum pressure in the infusion circuit and substitute vessel were measured. Bacterial culture of the saline infused sterilely was performed to estimate bacterial contamination. RESULTS The pressure-infusor group led to faster infusion of 500 ml of saline (233 ± 19 s) than the piston-pump group (301 ± 48 s) (P < 0.01). The infusion time at the third attempt (316 ± 43 s) was significantly longer than that at the first attempt (285 ± 53 s) only in the piston-pump group (P < 0.05). The maximum pressure (mmHg) in the circuit was 131 ± 9 and > 200 (P < 0.01) and in the substitute vessel was 5 ± 1 and 17 ± 7 (P < 0.01) in the pressure-infusor and piston-pump groups, respectively. A pressure of <-200 mmHg occurred at all infusion attempts in the piston-pump group. Bacterial contamination was not observed in either group. CONCLUSION If fluids must be administered rapidly, the pressure-infusor method is more efficient than the piston-pump method because the latter is less effective in infusing fluids rapidly and associated with excessive positive and negative pressure in the infusion circuit.