ArticleBMJ open2020
Tranexamic ACid during PancereaticoDuodenectomy (TAC-PD): study protocol for a multicentre randomised, blind, placebo-controlled trial.
Article in BMJ open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
- Efficacy and Safety of Tranexamic Acid in Cancer Surgery. An Update of Clinical Findings and Ongoing Research.Journal of multidisciplinary healthcare · 2022Review
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PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionPancreaticoduodenectomy (PD) is a major gastroenterological surgery that results in a substantial amount of blood loss. Several studies have demonstrated that major blood loss during PD is associated with both short-term and long-term poor outcomes. Administration of perioperative tranexamic acid (TXA) has been reported to reduce intraoperative blood loss in various surgeries, including cardiovascular surgery and orthopaedic surgery. Nevertheless, the effect of perioperative TXA use in patients undergoing PD has not been investigated. This study aims to investigate the effect of TXA on blood loss during PD. METHODS AND ANALYSIS: A multicentre (six hospitals), randomised, blind (patient-blinded, surgeon-blinded, anaesthesiologist-blinded, monitor-blinded), placebo-controlled trial of TXA during PD was started in September 2019. Patients undergoing PD for biliary, duodenal or pancreatic diseases are randomly assigned to the TXA or placebo group. The stratification factors are the institutions and preoperative clinical diagnosis. Before skin incision, the participants in TXA group are administrated 1 g TXA as a loading infusion followed by a maintenance infusion of 125 mg/hour TXA until the end of surgery or 8 hours from the incision. Participants in the placebo group are administrated the same volume of saline that is indistinguishable from the TXA. The primary outcome is blood loss during PD. The secondary outcomes are intraoperative and postoperative (up to day 2) blood transfusions, operation time, anaesthesia time, postoperative laboratory variables, length of hospital stay, in-hospital and 90-day mortality and postoperative complications occurring within 28 days of surgery or requiring readmission. To date, 115 patients of a planned 220 have been enrolled in the study. ETHICS AND DISSEMINATION: This protocol was approved by the Nagoya University Clinical Research Review Board and is registered with Japan Registry of Clinical Trials on 15 August 2019. The results of this trial will be disseminated through peer-reviewed journals. TRIAL REGISTRATION NUMBER: jRCTs041190062.
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