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

Autor: Guillaume Martel, Tori Lenet, Christopher Wherrett, François-Martin Carrier, Leah Monette, Aklile Workneh, Karine Brousseau, Monique Ruel, Michaël Chassé, Yves Collin, Franck Vandenbroucke-Menu, Élodie Hamel-Perreault, Michel-Antoine Perreault, Jeieung Park, Shirley Lim, Véronique Maltais, Philemon Leung, Richard W. D. Gilbert, Maja Segedi, Jad Abou-Khalil, Kimberly A. Bertens, Fady K. Balaa, Tim Ramsay, Dean A. Fergusson
Rok vydání: 2023
Předmět:
Zdroj: Trials. 24
ISSN: 1745-6215
Popis: Introduction Blood 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. Methods This 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 Discussion The 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 registration ClinicalTrials.gov NCT03651154. Registered on August 29 2018.
Databáze: OpenAIRE