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

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摘要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.

abstractsBackground::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.

作者 Liao Ren ^[1] Liu Jin ^[1] Zhang Wei ^[2] Zheng Hong ^[3] Zhu Zhaoqiong ^[4] Sun Haorui ^[5] Yu Zhangsheng ^[6] Jia Huiqun ^[7] Sun Yanyuan ^[8] Qin Li ^[9] Yu Wenli ^[10] Luo Zhen ^[1] Chen Yanqing ^[11] Zhang Kexian ^[12] Ma Lulu ^[13] Yang Hui ^[14] Wu Hong ^[15] Liu Limin ^[16] Yuan Fang ^[17] Xu Hongwei ^[1] Zhang Jianwen ^[2] Zhang Lei ^[3] Liu Dexing ^[4] Huang Han ^[18] 学术成果认领

作者单位 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 ^[1] Department of Anesthesiology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan 450052, China ^[2] Department of Anesthesiology, The First Affiliated Hospital of Xinjiang Medical University, Urumqi, Xinjiang 830054, China ^[3] Department of Anesthesiology, The Affiliated Hospital of Zunyi Medical College, Zunyi, Guizhou 563003, China ^[4] Department of Anesthesiology, Beijing Friendship Hospital of Capital Medical University, Beijing 100069, China ^[5] Department of Bioinformatics and Biostatistics, School of Life Science and Biotechnology, Shanghai Jiao Tong University, Shanghai 200240, China ^[6] Department of Anesthesiology, The Fourth Hospital of Hebei Medical University, Shijiangzhuang, Hebei 050019, China ^[7] Department of Anesthesiology, Xijing Hospital of the Fourth Military Medical University, Xi’an, Shaanxi 710032, China ^[8] Department of Transfusion, West China Hospital of Sichuan University, Chengdu, Sichuan 610041, China ^[9] Department of Anesthesiology, Tianjin First Center Hospital, Tianjin 300192, China ^[10] Department of Anesthesiology, Fujian Provincial Hospital, Fuzhou, Fujian 350001, China ^[11] Department of Anesthesiology, Sichuan Cancer Hospital amp; Institute, Chengdu, Sichuan 610041, China ^[12] Department of Anesthesiology, Peking Union Medical College Hospital, Beijing 100032, China ^[13] Department of Anesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430030, China ^[14] Department of Hepato-Bilio-Pancreatic Surgery, West China Hospital of Sichuan University, Chengdu, Sichuan 610041, China ^[15] Department of Orthopedic Surgery, West China Hospital of Sichuan University, Chengdu, Sichuan 610041, China ^[16] Department of Anesthesiology, General Hospital Affiliated to Tianjin Medical University, Tianjin 300052, China ^[17] Department of Anesthesiology and Translational Neuroscience Center, West China Second University Hospital of Sichuan University, Chengdu, Sichuan 610041, China ^[18]

关键词 Individualized transfusion strategy West-China-Liu’s Score Red cells Blood volume Hemoglobins Postoperative care Individualized transfusion strategy West-China-Liu’s Score Red cells Blood volume Hemoglobins Postoperative care

栏目名称 Original Article

DOI 10.1097/CM9.0000000000002584

发布时间 2025-02-25