Individualized red-cell transfusion strategy for non-cardiac surgery in adults: a randomized controlled trial.
- Author:
Ren LIAO
1
;
Jin LIU
1
;
Wei ZHANG
2
;
Hong ZHENG
3
;
Zhaoqiong ZHU
4
;
Haorui SUN
5
;
Zhangsheng YU
6
;
Huiqun JIA
7
;
Yanyuan SUN
8
;
Li QIN
9
;
Wenli YU
10
;
Zhen LUO
1
;
Yanqing CHEN
11
;
Kexian ZHANG
12
;
Lulu MA
13
;
Hui YANG
14
;
Hong WU
15
;
Limin LIU
16
;
Fang YUAN
17
;
Hongwei XU
1
;
Jianwen ZHANG
2
;
Lei ZHANG
3
;
Dexing LIU
4
;
Han HUANG
18
Author Information
- Publication Type:Journal Article
- MeSH: Humans; Adult; Postoperative Complications; Erythrocyte Transfusion/adverse effects*; Blood Transfusion; Hospitals; Hemoglobins/analysis*
- From: Chinese Medical Journal 2023;136(23):2857-2866
- CountryChina
- Language:English
-
Abstract:
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.