Safety and Efficacy of Acute Normovolemic Hemodilution in Female Patients: A Secondary Analysis of the ANH Trial.
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Pruna Alessandro, Scandroglio Anna Mara, Lei Chong, Oriani Alessandro, Di Fazio Aldo, Pontillo Domenico, Santonocito Cristina, Bonizzoni Matteo Aldo, Comis Marco, Calabrò Maria Grazia, Kadantseva Kristina, Barucco Gaia, Guarracino Fabio, Giardina Giuseppe, Ajello Valentina, Di Prima Ambra Licia, Osinsky Roman, Oliva Federico Mattia, Efremov Sergey, Mucchetti Marta, Vandyck Kofi B, Franco Annalisa, Arangino Cristina, Nardelli Pasquale, Ranucci Marco, D'Amora Mauro, Wang Lini, Zhang Hui, Lorsomradee Suraphong, Hajjar Ludhmila Abrahão, Ti Lian Kah, McNeil John S, Pieri Marina, Bove Tiziana, Gürcü Mustafa Emre, Rocco Monica, Landoni Giovanni, Paternoster Gianluca, Zangrillo Alberto, Monaco Fabrizio, ANH Study Group
Аннотация
OBJECTIVE: To evaluate the efficacy and safety of acute normovolemic hemodilution (ANH) compared with usual care in female patients undergoing elective cardiac surgery with cardiopulmonary bypass.
DESIGN, SETTING, AND PARTICIPANTS: This was a post hoc secondary analysis of the multicenter, randomized ANH trial, which was conducted at 32 centers in 11 countries from April 2019 to December 2024. Of 2010 patients in the original ANH trial, 405 were women and were included in this analysis; 219 had been randomized to receive ANH and 186 to usual care. This secondary analysis was conducted from August 2025 to January 2026.
INTERVENTION: Withdrawal of at least 650 mL whole blood with crystalloids replacement and reinfusion after cardiopulmonary bypass.
MAIN OUTCOMES AND MEASURES: The primary outcome was the occurrence of at least 1 allogeneic packed red blood cell (pRBC) transfusion during the index hospitalization. Safety outcomes included intraoperative hypotension, intensive care unit (ICU) length of stay, hospital length of stay, mortality, and other perioperative complications.
RESULTS: The median (IQR) age of the participants was 62 (54-69) years. The occurrence of allogeneic pRBC transfusion was similar in the ANH and usual care groups (38.8% vs 44.6%, respectively; relative risk [RR], 0.87; 95% CI, 0.69-1.10; P = .24). Intraoperative hypotension occurred more frequently with ANH (16.0% vs 4.8% in usual care; RR, 3.30; 95% CI, 1.62-6.74; P = .02). Patients receiving ANH also had longer ICU stays (mean difference, 21.13 hours; 95% CI, 1.89-40.38; P = .03) and hospital stays (mean difference, 1.92 days; 95% CI, 0.14-3.70; P = .04). No significant differences were observed in mortality or other postoperative complications.
CONCLUSIONS AND RELEVANCE: In this post hoc secondary analysis of a randomized clinical trial, ANH was not associated with a reduction in allogeneic pRBC transfusion among women undergoing cardiac surgery and was associated with more frequent intraoperative hypotension and longer ICU and hospital stay. These exploratory findings warrant confirmation in adequately powered studies specifically designed to evaluate female patients undergoing cardiac surgery.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03913481.