International multicentre observational study to evaluate the association between perioperative red blood cell transfusions and 1-year mortality after major cancer surgery (ARCA-1): study design, statistical analysis plan and study protocol
Lei Feng,
Patrice Forget,
Juan Cata,
Ary Serpa Neto,
Maria Ramirez,
Lee-Lynn Chen,
Oscar Diaz-Cambronero,
Wankun Chen,
Matthew A Warner,
Adriana Knopfelmacher Couchonal,
Paolo Pelosi,
Luis Cuellar,
German Corrales,
Carlos Romero,
Francisco Lobo,
Leif Saager,
Jorge Castro Tapia,
Roy Kiberenge
Affiliations
Lei Feng
Key Laboratory of Ophthalmology of Zhejiang Province, Hangzhou, China
Patrice Forget
clinical chair in anaesthesia and honorary consultant
Juan Cata
Department of Anesthesiology and Perioperative Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA
Ary Serpa Neto
6 Monash University, Melbourne, Victoria, Australia
Maria Ramirez
Department of Anesthesiology and Perioperative Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA
Lee-Lynn Chen
Department of Anesthesiology, University of California San Francisco, San Francisco, California, USA
Oscar Diaz-Cambronero
2 Anesthesiology and Critical Care, Hospital la Fe, Valencia, Spain
Wankun Chen
Department of Anaesthesiology, Zhongshan Hospital Fudan University, Shanghai, Shanghai, China
Matthew A Warner
Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, Minnesota, USA
Adriana Knopfelmacher Couchonal
Department of Laboratory Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA
Paolo Pelosi
Dipartimento di Scienze Chirurgiche e Diagnostiche, Università degli Studi di Genova, Genoa, Italy
Luis Cuellar
Department of Anesthesiology, Instituto Nacional de Cancerología, Mexico, Mexico
German Corrales
Department of Anesthesiology and Perioperative Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA
Carlos Romero
Department of Anesthesiology, Buenos Aires, Argentina
Francisco Lobo
Anesthesiology institute, Cleveland clinic abu dhabi, Abu Dhabi, United Arab Emirates
Leif Saager
Klinik für Anästhesiologie, Universitätsmedizin Göttingen, Gottingen, Niedersachsen, Germany
Jorge Castro Tapia
Department of Anesthesiology, Clinica Alemana de Santiago SA, Vitacura, Chile
Roy Kiberenge
Department of Anesthesiology, University of Minnesota System, Minneapolis, Minnesota, USA
Introduction Blood transfusion is still common in patients undergoing major cancer surgery. Blood transfusion can be associated with poor prognosis in patients with cancer. Perioperative Care in the Cancer Patient -1 (ARCA-1) aims to assess in a large cohort of patients the current incidence, pattern of practice and associations between perioperative blood transfusions and 1-year survival in patients undergoing major cancer surgery.Methods and analysis ARCA-1 is a prospective international multicentre observational study that will include adult patients scheduled to have major cancer surgical procedures with the intention to cure, and an overnight planned hospital admission. The study will be opened for 1 year for enrolment (7 January 2020–7 February 2021). Each centre will enrol patients for 30 days. The primary endpoint of this study is all-cause mortality 1 year after major cancer surgery. Secondary endpoints are rate of perioperative blood product use, cancer-specific mortality at 1 year and PFSs and 30-day morbidity and mortality.Ethics and dissemination This study was approved by the Institutional Review Board at The University of Texas—MD Anderson Cancer Center. The study results will be published in peer-reviewed journals and disseminated at international conferences.Trial registration number NCT04491409.
