Individualized red-cell transfusion strategy for non-cardiac surgery in adults:a randomized controlled trial

Background:Red-cell transfusion is critical for surgery during the peri-operative period;however,the transfusion threshold remains controversial mainly owing to the diversity among patients.The patient’s medical status should be evaluated before making a transfusion decision.Herein,we developed an individualized transfusion strategy using the West-China-Liu’s Score based on the physiology of oxygen delivery/consumption balance and designed an open-label,multicenter,randomized clinical trial to verify whether it reduced red cell requirement as compared with that associated with restrictive and liberal strategies safely and effectively,providing valid evidence for peri-operative transfusion.Methods:Patients aged>14 years undergoing elective non-cardiac surgery with estimated blood loss>1000 mL or 20%blood volume and hemoglobin concentration<10 g/dL were randomly assigned to an individualized strategy,a restrictive strategy following China’s guideline or a liberal strategy with a transfusion threshold of hemoglobin concentration<9.5 g/dL.We evaluated two primary outcomes:the proportion of patients who received red blood cells(superiority test)and a composite of in-hospital complications and all-cause mortality by day 30(non-inferiority test).Results:We enrolled 1182 patients:379,419,and 384 received individualized,restrictive,and liberal strategies,respectively.Approximately 30.6%(116/379)of patients in the individualized strategy received a red-cell transfusion,less than 62.5%(262/419)in the restrictive strategy(absolute risk difference,31.92%;97.5%confidence interval[CI]:24.42-39.42%;odds ratio,3.78%;97.5%CI:2.70-5.30%;P<0.001),and 89.8%(345/384)in the liberal strategy(absolute risk difference,59.24%;97.5%CI:52.91-65.57%;odds ratio,20.06;97.5%CI:12.74-31.57;P<0.001).No statistically significant differences were found in the composite of in-hospital complications and mortality by day 30 among the three strategies.Conclusion:The individualized red-cell transfusion strategy using the West-China-Liu’s Score reduced red-cell transfusion without increasing in-hospital complications and mortality by day 30 when compared with restrictive and liberal strategies in elective non-cardiac surgeries.Trial registration:ClinicalTrials.gov,NCT01597232.