Trial protocol: preoperative administration of tranexamic acid in sleeve gastrectomy (PATAS) to reduce haemorrhage rates. A randomised controlled trial
Autor: | M. Leeman, Jeannine Huisbrink, Martin Dunkelgrun, L Ulas Biter, Julie M A Wijnand, Jan A Apers, Serge J. C. Verbrugge |
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Jazyk: | angličtina |
Rok vydání: | 2020 |
Předmět: |
Adult
medicine.medical_specialty Sleeve gastrectomy medicine.medical_treatment hemostatic clips Postoperative Hemorrhage Placebo tranexamic acid law.invention Randomized controlled trial Double-Blind Method law Informed consent Gastrectomy Preoperative Care medicine Protocol Humans Randomized Controlled Trials as Topic business.industry Incidence (epidemiology) General Medicine Venous Thromboembolism fast-track bleeding Antifibrinolytic Agents Surgery Treatment Outcome Secondary Outcome Measure Medicine Fast track business ERABS Tranexamic acid sleeve gastrectomy medicine.drug |
Zdroj: | BMJ Open, Vol 10, Iss 2 (2020) BMJ Open |
ISSN: | 2044-6055 |
Popis: | IntroductionFast-track protocols often include short-term thromboprophylaxis and short length of hospital stay. These treatment strategies may negatively affect the occurrence and diagnosis of postoperative haemorrhage. Over the years, the rates of venous thromboembolic events (VTEs) have decreased, while there seems to be an increase in the occurrence of postoperative haemorrhage. Tranexamic acid (TXA) can potentially lower the incidence of postoperative haemorrhage. This trial aims to investigate whether preoperative administration of TXA reduces the preoperative and postoperative haemorrhage rates in laparoscopic sleeve gastrectomy (LSG).Methods and analysisThis is a single centre double-blind randomised placebo-controlled trial. Patients undergoing an LSG are included after obtaining informed consent. Patients are randomised between two groups: (1) administration of placebo infusion and (2) administration of 1500 mg TXA. In both groups, the infusions will be administered during the induction phase of the procedure. Primary outcome measures are preoperative use of haemostatic clips, postoperative haemoglobin decrease and postoperative haemorrhage. Secondary outcome measure is the rates of VTE.Ethics and disseminationThe protocol version 3 was approved by the medical ethical committee Medical Research Ethics Committees United (MEC-U), Nieuwegein, on 29 July 2019. The trial results will be submitted for publication in a peer-reviewed journal and at conference presentations.Trial registration numberThe Netherlands Trial Registry (NL8029); Pre-results. |
Databáze: | OpenAIRE |
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