Individualised acute normovolaemic haemodilution for non-cardiac surgery with anticipated high-dose red cell transfusion: study protocol for a randomised controlled trial in West China Hospital of Sichuan University.

Abstract

Acute normovolaemic haemodilution (ANH) is a perioperative blood management technique involving the removal of whole blood and simultaneous infusion of colloids or crystalloids to achieve haemodilution while maintaining normovolaemia. However, its efficacy in reducing the requirement for perioperative allogeneic blood transfusion remains controversial due to inconsistent findings in the literature. An individualised red cell transfusion strategy, guided by the West China Liu's Score, has demonstrated effectiveness in reducing the need for allogeneic red cell transfusion. Building on this evidence, we propose an individualised ANH approach and hypothesise that individualised ANH, guided by the West China Liu's Score, can reduce the requirement for allogeneic red cells during the perioperative period. This is a single centre, prospective, randomised controlled trial designed to evaluate the superiority of the individualised ANH, based on the West China Liu's Score, in reducing perioperative red cell requirements compared with current clinical practice. Adult patients undergoing elective non-cardiac surgery with an anticipated red cell transfusion volume exceeding eight units (or 1600 mL) will be enrolled and randomly allocated to either the 'ANH group' or the 'Control group' in a 1:1 ratio. The primary outcome is the perioperative consumption of the allogeneic red blood cells. Data analysis will adhere to the intent-to-treat principle. The study protocol (V.1.0) has been approved by the Biological Medical Ethical Committee of the West China Hospital of Sichuan University, with approval No. 2024(595) on 17 April 2024. The results of this trial will be disseminated by publication in peer-reviewed journals and academic conference presentations. National Institutes of Health Clinical Trials Registry, NCT06399536. 2 May 2024.