意大利圣拉斐尔医院Alberto Zangrillo团队进行了心脏手术中急性等容血稀释的随机试验。该项研究成果发表在2025年6月12日出版的《新英格兰医学杂志》上。

接受心脏手术的患者经常接受红细胞输注，伴随着相关的风险和成本。术中早期等容血液稀释（即急性等容血液稀释[ANH]）是一种血液保存技术，需要在体外循环开始前采集自体血液，并在体外循环断开后将采集的血液重新输注。ANH是否能减少接受异体红细胞输血的患者数量还需要更多的数据。

在一项多国单盲试验中，研究组随机分配来自11个国家32个中心的接受心脏手术合并体外循环的成年人接受ANH（如果需要，提取≥650 ml全血并置换晶体）或常规护理。主要结局是住院期间输血至少一个单位的异体红细胞。次要结局是手术后30天内或手术住院期间因全因死亡、出血并发症、缺血性并发症和急性肾损伤。

共有2010例患者接受随机分组；1010人被分配到ANH， 1000人被分配到常规护理。在可获得数据的患者中，1005例ANH组中有274例（27.3%）接受了至少一次异体红细胞输血，997例常规护理组中有291例（29.2%）接受了至少一次异体红细胞输血(相对风险为0.93；95%置信区间为0.81 ~ 1.07；P = 0.34)。1004例ANH组患者中有38例（3.8%）进行了术后出血手术，995例常规护理组患者中有26例（2.6%）进行了术后出血手术。1008例ANH组患者中有14例（1.4%）在30天内或住院期间死亡，997例常规护理组患者中有16例（1.6%）死亡。两组的安全性结果相似。

研究结果表明，在接受心脏手术的成年人中，ANH并没有减少接受同种异体红细胞输血的患者数量。

附：英文原文

Title: A Randomized Trial of Acute Normovolemic Hemodilution in Cardiac Surgery

Author: Fabrizio Monaco, Chong Lei, Matteo Aldo Bonizzoni, Sergey Efremov, Federica Morselli, Fabio Guarracino, Giuseppe Giardina, Cristina Arangino, Domenico Pontillo, Michelangelo Vitiello, Alessandro Belletti, Valentina Ajello, Margherita Licheri, Caetano Nigro Neto, Gaia Barucco, Nazar A. Bukamal, Carolina Faustini, Lorenzo Filippo Mantovani, Alessandro Oriani, Cristina Santonocito, Marta Mucchetti, Francesco Federici, Chiara Gerli, Sabrina Porta, Anna Mara Scandroglio, Hui Zhang, Marina Pieri, Roman Osinsky, Stefano Lazzari, Elizaveta Leonova, Maria Grazia Calabrò, Daniele Amitrano, Stefano Turi, Paolo Prati, Stefano Fresilli, Filippo D’Amico, Jacopo D’Andria Ursoleo, Rosa Labanca, Marilena Marmiere, Alessandro Pruna, Tommaso Scquizzato, Kaan Krali, Giacomo Monti, Maria José Carvalho Carmona, Kenichi Tanaka, Valery Likhvantsev, Lian Kah Ti, Tiziana Bove, Gianluca Paternoster, Karen Singh, Mustafa Emre Gürcü, Vladimir Lomivorotov, Giovanni Landoni, Rinaldo Bellomo, Alberto Zangrillo

Issue&Volume: 2025-06-12

Abstract:

BACKGROUND

Patients undergoing cardiac surgery often receive red-cell transfusions, along with the associated risks and costs. Early intraoperative normovolemic hemodilution (i.e., acute normovolemic hemodilution [ANH]) is a blood-conservation technique that entails autologous blood collection before initiation of cardiopulmonary bypass and reinfusion of the collected blood after bypass weaning. More data are needed on whether ANH reduces the number of patients receiving allogeneic red-cell transfusion.

METHODS

In a multinational, single-blind trial, we randomly assigned adults from 32 centers and 11 countries who were undergoing cardiac surgery with cardiopulmonary bypass to receive ANH (withdrawal of ≥650 ml of whole blood with crystalloids replacement if needed) or usual care. The primary outcome was the transfusion of at least one unit of allogeneic red cells during the hospital stay. Secondary outcomes were death from any cause within 30 days after surgery or during the hospitalization for surgery, bleeding complications, ischemic complications, and acute kidney injury.

RESULTS

A total of 2010 patients underwent randomization; 1010 were assigned to ANH and 1000 to usual care. Among patients with available data, 274 of 1005 (27.3%) in the ANH group and 291 of 997 (29.2%) in the usual-care group received at least one allogeneic red-cell transfusion (relative risk, 0.93; 95% confidence interval, 0.81 to 1.07; P=0.34). Surgery for postoperative bleeding was performed in 38 of 1004 patients (3.8%) in the ANH group and 26 of 995 patients (2.6%) in the usual-care group. Death within 30 days or during hospitalization occurred in 14 of 1008 patients (1.4%) in the ANH group and 16 of 997 patients (1.6%) in the usual-care group. Safety outcomes were similar in the two groups.

CONCLUSIONS

Among adults undergoing cardiac surgery, ANH did not reduce the number of patients receiving allogeneic red-cell transfusion.

DOI: NJ202506120000002

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2504948