• Chinese medical journal · Dec 2023

    Randomized Controlled Trial Multicenter Study

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

    • Ren Liao, Jin Liu, Wei Zhang, Hong Zheng, Zhaoqiong Zhu, Haorui Sun, Zhangsheng Yu, Huiqun Jia, Yanyuan Sun, Li Qin, Wenli Yu, Zhen Luo, Yanqing Chen, Kexian Zhang, Lulu Ma, Hui Yang, Hong Wu, Limin Liu, Fang Yuan, Hongwei Xu, Jianwen Zhang, Lei Zhang, Dexing Liu, and Han Huang.
    • Department of Anesthesiology, Research Unit for Perioperative Stress Assessment and Clinical Decision, Chinese Academy of Medical Sciences (2018RU012), West China Hospital of Sichuan University, Chengdu, Sichuan 610041, China.
    • Chin. Med. J. 2023 Dec 5; 136 (23): 285728662857-2866.

    BackgroundRed-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.MethodsPatients 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).ResultsWe 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.ConclusionThe 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 RegistrationClinicalTrials.gov, NCT01597232.Copyright © 2023 The Chinese Medical Association, produced by Wolters Kluwer, Inc. under the CC-BY-NC-ND license.

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