Individualized Red-Cell Transfusion Strategy for Non-Cardiac Surgery in Adults: A Randomised Controlled Trial

Background: We developed an individualized transfusion strategy and it might reduce red-cell requirement without compromising patients' safety as compared with restrictive and liberal strategies for surgery, in order to access the safety and cost-effectiveness of a practical individualized red-cell transfusion strategy by using the West-China-Liu's Score based on the physiology of oxygen delivery/consumption balance. Methods: This open labeled, multicenter, randomised clinical trial was conducted in 35 Chinese Hospitals from May 2012 to January 2016, with follow-up until January 2017. Among 1351 eligible patients undergoing non-cardiac surgeries, 1213 were randomised, 1182 were included in the final analysis. Patients with haemoglobin concentration <10 g per deciliter due to surgical bleeding were randomly assigned to an individualized-strategy (n=379) using the West-China-Liu's Score, a restrictive-strategy (n=419) following China's guideline, or a liberal-strategy (n=384) with transfusion threshold of haemoglobin concentration < 9.5 g per deciliter. There were two primary outcomes. First, the proportion of patients received red-cell (superiority test); Second, a composite of in-hospital complications and all-cause mortality by day-30 (noninferiority test). The secondary outcomes included allogeneic blood cost and total in-hospital cost, all-cause mortality by day-60, day-180 and 1-year, in-hospital complications and infection rate, ICU admission rate, incision healing status and length of hospital stay after surgery. Findings: The main findings were that 30.6% patients in the individualized-strategy received red-cell transfusion, less than 62.4% in the restrictive-strategy (absolute risk difference, 31.92 percentage points; 97.5% confidence interval[CI] 24.42 to 39.42; odds ratio, 3.78; 97.5%CI, 2.7 to 5.3; p<0.001) and 89.8% in the liberal-strategy (absolute risk difference, 59.24 percentage points; 97.5%CI, 52.91 to 65.57; odds ratio, 20.06; 97.5%CI, 12.74 to 31.57; p<0.001), and no differences were found for composite of in-hospital complications and mortality by day-30 among the three strategies. Interpretation: The individualized red cells transfusion strategy using the West-China-Liu's Score reduced red-cell transfusion without increase of in-hospital complications and mortality by day-30 when compared with restrictive and liberal strategies in elective non-cardiac surgeries. Trial Registration: The study protocol was registered at http://www.clinicaltrials.gov (NCT01597232). Funding Statement: This trial was funded by National Key R&D Program of China (2018YFC2001800), the 1-3-5 Project for disciplines of excellence, West China Hospital, and the Sichuan University Education Foundation. Declaration of Interests: The authors declare no competing interests. Ethics Approval Statement: This study protocol has been first approved by the Biological- Medical Ethical Committee of West China Hospital, Sichuan University, Chengdu, Sichuan, China on 10 January 2012, and then approved by all the participating centers successively.