Phlebotomy resulting in controlled hypovolemia to prevent blood loss in major hepatic resections (PRICE-2): study protocol for a phase 3 randomized controlled trial

Trials

Study Protocol

Dean A. Fergusson¹  Tim Ramsay¹  Michel-Antoine Perreault²  Élodie Hamel-Perreault²  Shirley Lim³  Jeieung Park³  Monique Ruel⁴  François-Martin Carrier⁵  Michaël Chassé⁶  Richard W. D. Gilbert⁷  Maja Segedi⁷  Véronique Maltais⁷  Philemon Leung⁷  Christopher Wherrett⁸  Yves Collin⁹  Franck Vandenbroucke-Menu^1,10  Fady K. Balaa^1,11  Kimberly A. Bertens^1,11  Jad Abou-Khalil^1,11  Leah Monette^1,12  Tori Lenet^1,12  Karine Brousseau^1,12  Guillaume Martel^1,12  Aklile Workneh^1,12 

[1] Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada;Departement of Anesthesiology, Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, QC, Canada;Department of Anesthesiology and Perioperative Care, Vancouver General Hospital, University of British Columbia, Vancouver, BC, Canada;Department of Anesthesiology, Centre Hospitalier de l’Université de Montréal, Université de Montréal, Montréal, QC, Canada;Department of Anesthesiology, Centre Hospitalier de l’Université de Montréal, Université de Montréal, Montréal, QC, Canada;Department of Medicine, Critical Care Division, Centre Hospitalier de l’Université de Montréal, Université de Montréal, Montréal, QC, Canada;Department of Medicine, Critical Care Division, Centre Hospitalier de l’Université de Montréal, Université de Montréal, Montréal, QC, Canada;Department of Surgery, Vancouver General Hospital, University of British Columbia, Vancouver, BC, Canada;Departments of Anesthesiology and Pain Medicine, The Ottawa Hospital, University of Ottawa, Ottawa, ON, Canada;Division of General Surgery, Department of Surgery, Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, QC, Canada;Hepato-Pancreato-Biliary and Liver Transplantation Surgery Unit, Department of Surgery - Centre Hospitalier de l’Université de Montréal, Montréal, QC, Canada;Liver and Pancreas Unit, Department of Surgery, The Ottawa Hospital– General Campus, University of Ottawa, 501 Smyth Road, CCW 1667, K1H 8L6, Ottawa, ON, Canada;Liver and Pancreas Unit, Department of Surgery, The Ottawa Hospital– General Campus, University of Ottawa, 501 Smyth Road, CCW 1667, K1H 8L6, Ottawa, ON, Canada;Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada;

关键词: Hepatectomy;    Liver resection;    Phlebotomy;    Hypovolemia;    Hemodilution;    Blood transfusion;    Blood loss;    Autologous blood transfusion;    Randomized controlled trial;   

DOI  :  10.1186/s13063-022-07008-y

 received in 2022-10-22, accepted in 2022-12-12,  发布年份 2022

来源: Springer

【 摘 要 】

IntroductionBlood loss and red blood cell (RBC) transfusion in liver surgery are areas of concern for surgeons, anesthesiologists, and patients alike. While various methods are employed to reduce surgical blood loss, the evidence base surrounding each intervention is limited. Hypovolemic phlebotomy, the removal of whole blood from the patient without volume replacement during liver transection, has been strongly associated with decreased bleeding and RBC transfusion in observational studies. This trial aims to investigate whether hypovolemic phlebotomy is superior to usual care in reducing RBC transfusions in liver resection.MethodsThis study is a double-blind multicenter randomized controlled trial. Adult patients undergoing major hepatic resections for any indication will be randomly allocated in a 1:1 ratio to either hypovolemic phlebotomy and usual care or usual care alone. Exclusion criteria will be minor resections, preoperative hemoglobin <100g/L, renal insufficiency, and other contraindication to hypovolemic phlebotomy. The primary outcome will be the proportion of patients receiving at least one allogeneic RBC transfusion unit within 30 days of the onset of surgery. Secondary outcomes will include transfusion of other allogeneic blood products, blood loss, morbidity, mortality, and intraoperative physiologic parameters. The surgical team will be blinded to the intervention. Randomization will occur on the morning of surgery. The sample size will comprise 440 patients. Enrolment will occur at four Canadian academic liver surgery centers over a 4-year period. Ethics approval will be obtained at participating sites before enrolment.DiscussionThe results of this randomized control trial will provide high-quality evidence regarding the use of hypovolemic phlebotomy in major liver resection and its effects on RBC transfusion. If proven to be effective, this intervention could become standard of care in liver operations internationally and become incorporated within perioperative patient blood management programs.Trial registrationClinicalTrials.gov NCT03651154. Registered on August 29 2018.

【 授权许可】

CC BY   
© The Author(s) 2023

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