학술논문
Argipressin for prevention of blood loss during liver resection: a study protocol for a randomised, placebo-controlled, double-blinded trial (ARG-01).
Document Type
Academic Journal
Author
Wisén E; Department of Anaesthesiology and Intensive Care, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Västra Götaland, Sweden ellinor.wisen@vgregion.se.; Department of Anaesthesia and Intensive Care, Sahlgrenska University Hospital, Gothenburg, Sweden.; Kvarnström A; Department of Anaesthesiology and Intensive Care, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Västra Götaland, Sweden.; Department of Anaesthesia and Intensive Care, Sahlgrenska University Hospital, Gothenburg, Sweden.; Sand-Bown L; Department of Anaesthesia and Intensive Care, Sahlgrenska University Hospital, Gothenburg, Sweden.; Rizell M; Transplantation Center, Sahlgrenska University Hospital, Gothenburg, Sweden.; Deparment of Surgery, University of Gothenburg Institute of Clinical Sciences, Goteborg, Västra Götaland, Sweden.; Pivodic A; Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.; APNC Sweden, Gothenburg, Sweden.; Ricksten SE; Department of Anaesthesiology and Intensive Care, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Västra Götaland, Sweden.; Svennerholm K; Department of Anaesthesiology and Intensive Care, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Västra Götaland, Sweden.; Department of Anaesthesia and Intensive Care, Sahlgrenska University Hospital, Gothenburg, Sweden.
Source
Publisher: BMJ Publishing Group Ltd Country of Publication: England NLM ID: 101552874 Publication Model: Electronic Cited Medium: Internet ISSN: 2044-6055 (Electronic) Linking ISSN: 20446055 NLM ISO Abbreviation: BMJ Open Subsets: MEDLINE
Subject
Language
English
Abstract
Introduction: Liver resection carries a high risk for extensive bleeding and need for blood transfusions, which is associated with significant negative impact on outcome. In malignant disease, the most common indication for surgery, it also includes increased risk for recurrence of cancer. Argipressin decreases liver and portal blood flow and may have the potential to reduce bleeding during liver surgery, although this has not been explored.
Method and Analysis: ARG-01 is a prospective, randomised, placebo-controlled, double-blinded study on 248 patients undergoing liver resection at Sahlgrenska University Hospital, Sweden. Patients will be randomised to one of two parallel groups, infusion of argipressin or normal saline administered peroperatively. The primary endpoint is peroperative blood loss. Secondary outcomes include need for blood transfusion, perioperative variables, length of hospital stay, the inflammatory response, organ damage markers and complications at 30 days.
Ethics and Dissemination: The study is enrolling patients since March 2022. The trial is approved by the Swedish Ethical Review Authority (Dnr 2021-03557) and the Swedish Medical Product Agency (Dnr 5.1-2021-90115). Results will be announced at scientific meetings and in international peer-reviewed journals.
Trial Registration Number: ClinicalTrials.gov, NCT05293041 and EudraCT, 2021-001806-32.
Competing Interests: Competing interests: None declared.
(© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Method and Analysis: ARG-01 is a prospective, randomised, placebo-controlled, double-blinded study on 248 patients undergoing liver resection at Sahlgrenska University Hospital, Sweden. Patients will be randomised to one of two parallel groups, infusion of argipressin or normal saline administered peroperatively. The primary endpoint is peroperative blood loss. Secondary outcomes include need for blood transfusion, perioperative variables, length of hospital stay, the inflammatory response, organ damage markers and complications at 30 days.
Ethics and Dissemination: The study is enrolling patients since March 2022. The trial is approved by the Swedish Ethical Review Authority (Dnr 2021-03557) and the Swedish Medical Product Agency (Dnr 5.1-2021-90115). Results will be announced at scientific meetings and in international peer-reviewed journals.
Trial Registration Number: ClinicalTrials.gov, NCT05293041 and EudraCT, 2021-001806-32.
Competing Interests: Competing interests: None declared.
(© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)