Argipressin for prevention of blood loss during liver resection: a study protocol for a randomised, placebo-controlled, double-blinded trial (ARG-01)
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. Argipressi...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2023-08-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/8/e073270.full |
| _version_ | 1797737365221933056 |
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| author | Aldina Pivodic Magnus Rizell Kristina Svennerholm Ellinor Wisén Andreas Kvarnström Lena Sand-Bown Sven-Erik Ricksten |
| author_facet | Aldina Pivodic Magnus Rizell Kristina Svennerholm Ellinor Wisén Andreas Kvarnström Lena Sand-Bown Sven-Erik Ricksten |
| author_sort | Aldina Pivodic |
| collection | DOAJ |
| description | 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 |
| first_indexed | 2024-03-12T13:28:37Z |
| format | Article |
| id | doaj.art-978712edec8f4532ad90da9ea101ed4d |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-03-12T13:28:37Z |
| publishDate | 2023-08-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-978712edec8f4532ad90da9ea101ed4d2023-08-25T03:45:07ZengBMJ Publishing GroupBMJ Open2044-60552023-08-0113810.1136/bmjopen-2023-073270Argipressin for prevention of blood loss during liver resection: a study protocol for a randomised, placebo-controlled, double-blinded trial (ARG-01)Aldina Pivodic0Magnus Rizell1Kristina Svennerholm2Ellinor Wisén3Andreas Kvarnström4Lena Sand-Bown5Sven-Erik Ricksten6Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, SwedenAff439 grid.8761.80000000099199582Transplant InstituteSahlgrenska Academy at University of Gothenburg Gothenburg SwedenUniversity of Gothenburg, Gothenburg, SwedenDepartment of Anaesthesiology and Intensive Care, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Västra Götaland, SwedenDepartment of Anaesthesiology and Intensive Care, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Västra Götaland, SwedenDepartment of Anaesthesia and Intensive Care, Sahlgrenska University Hospital, Gothenburg, SwedenDepartment of Anaesthesiology and Intensive Care, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Västra Götaland, SwedenIntroduction 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, 2021-001806-32https://bmjopen.bmj.com/content/13/8/e073270.full |
| spellingShingle | Aldina Pivodic Magnus Rizell Kristina Svennerholm Ellinor Wisén Andreas Kvarnström Lena Sand-Bown Sven-Erik Ricksten Argipressin for prevention of blood loss during liver resection: a study protocol for a randomised, placebo-controlled, double-blinded trial (ARG-01) BMJ Open |
| title | Argipressin for prevention of blood loss during liver resection: a study protocol for a randomised, placebo-controlled, double-blinded trial (ARG-01) |
| title_full | Argipressin for prevention of blood loss during liver resection: a study protocol for a randomised, placebo-controlled, double-blinded trial (ARG-01) |
| title_fullStr | Argipressin for prevention of blood loss during liver resection: a study protocol for a randomised, placebo-controlled, double-blinded trial (ARG-01) |
| title_full_unstemmed | Argipressin for prevention of blood loss during liver resection: a study protocol for a randomised, placebo-controlled, double-blinded trial (ARG-01) |
| title_short | Argipressin for prevention of blood loss during liver resection: a study protocol for a randomised, placebo-controlled, double-blinded trial (ARG-01) |
| title_sort | argipressin for prevention of blood loss during liver resection a study protocol for a randomised placebo controlled double blinded trial arg 01 |
| url | https://bmjopen.bmj.com/content/13/8/e073270.full |
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