Mid-term analysis of a randomized controlled clinical trial on different transfusion strategies for cardiac valve surgery
10.3760/cma.j.cn112139-20250421-00212
- VernacularTitle:心脏瓣膜手术不同输血策略临床随机对照研究中期分析
- Author:
Zhaolong ZHANG
1
;
Xuankun XIE
;
Yanji QU
;
Lishan ZHONG
;
Shanwen PANG
;
Linbin HUA
;
Qiuji WANG
;
Heng ZUO
;
Junqiang QIU
;
Huanlei HUANG
Author Information
1. 广东省心血管病研究所 广东省人民医院 广东省医学科学院，广州 510080
- Publication Type:Journal Article
- Keywords:
Heart valve diseases;
Cardiac surgery procedures;
Transfusion strategy;
Prognosis
- From:
Chinese Journal of Surgery
2025;63(8):695-703
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To compare the clinical effects of restrictive transfusion strategy and liberal transfusion strategy for cardiac valve surgery.Methods:This study employed a prospective, randomized controlled superiority design, enrolling 439 patients undergoing non-emergency cardiac valve surgery with cardiopulmonary bypass at Department of Cardiovascular Surgery, Guangdong Provincial People′s Hospital, Southern Medical University from June 2023 to October 2024 who met the inclusion and exclusion criteria. While all the patients appeared hematocrit (Hct)≤24% or hemoglobin (Hb)≤80 g/L during the cardiopulmonary bypass. A simple random design was adopted to generate a random sequence and participants were randomized into a restrictive transfusion group (restrictive criteria: Hct≤18% or Hb≤60 g/L during cardiopulmonary bypass, and Hct≤21% or Hb≤70 g/L postoperatively) or a liberal transfusion group (liberal criteria: Hct≤24% or Hb≤80 g/L during cardiopulmonary bypass and Hct≤30% or Hb≤100 g/L postoperatively). If Hb or Hct fell below the respective thresholds, 2 units of red blood cells were transfused, followed by re-evaluation. If levels remained below the threshold, an additional 2 units were transfused until the criteria were met. The primary outcome was a composite of postoperative 3-month mortality, infection, ischemic events, and new-onset renal failure requiring dialysis. Secondary outcomes included blood product utilization, length of stay in the ICU and so on. Intergroup comparisons were performed using independent sample t-test, Mann-Whitney U test, χ2 test, or Fisher′s exact test, and analyses were conducted using a binary multivariable Logistic regression model. Results:A total of 439 patients were included in this study. The restrictive roup included 221 patients, including 75 males and 146 females, aged ( M(IQR)) 57.0 (14.0) years (range: 21 to 76 years). The liberal group included 218 patients, including 67 males and 151 females, aged 56.0 (20.0) years (range: 19 to 74 years). No statistically significant difference was observed in the incidence of primary outcome (restrictive group: 10.9%(24/221) vs. liberal group: 9.6%(21/218), χ2=0.180, P>0.05), 2 patints in the restrictive group died and 3 patints in liberal group died ( P=0.684). The transfusion rate was significantly lower in the restrictive group(19.0%(42/221) vs. 100%(218/218), P<0.01), with no significant differences in other secondary outcomes (all P>0.05). Subgroup analysis revealed an interaction between sex and transfusion strategy ( P=0.023), suggesting that using liberal transfusion strategy in male patients might increase the risk of the primary outcome. Conclusion:The mid-term results do not show that the restrictive transfusion strategy is superior to the liberal transfusion strategy in reducing the incidence of postoperative outcome events in patients undergoing cardiac valve surgery.
