Restrictive vs Liberal Transfusion Strategy in Patients With Acute Brain Injury
Authors: Fabio Silvio Taccone, Carla Rynkowski Bittencourt, Kirsten Møller, Piet Lormans, Manuel Quintana-Díaz, Anselmo Caricato, Marco Antonio Cardoso Ferreira, Rafael Badenes, Pedro Kurtz, Christian Baastrup Søndergaard, Kirsten Colpaert, Leticia Petterson, Herve Quintard, Raphael Cinotti, Elisa Gouvêa Bogossian, Cassia Righy, Serena Silva, Erik Roman-Pognuz, Catherine Vandewaeter, Daniel Lemke, Olivier Huet, Ata Mahmoodpoor, Aaron Blandino Ortiz, Mathieu van der Jagt, Russell Chabanne, Walter Videtta, Pierre Bouzat, Jean-Louis Vincent, Claudia Díaz, Andrés Saravia, Ahmas Bayrlee, Laura Nedolast, Hussam Elkambergy, Haamid Siddique, Jihad Mallat, Nahla AlJaberi, Samer Shoshan, Ayo Mandi, Bruno De Oliveira, Malligere Prasanna, Rehan Haque, Dnyaneshwar Munde, Sara Chaffee, Fatma Alawadhi, Jamil Dibu, Eija Junttila, Teemu Luoto, Simona Šteblaj, Jacques Creteur, Dominique Durand, Caroline Abbenhuijs, Nancy Itesa Matumikina, Filippo Annoni, Leda Nobile, Miguel Ulloa Bersatti, Igor Yovenko, Alexander Tsarev, Jasperina Dubois, Evy Voets, Luc Janssen, Luigi Zattera, Leire Pedrosa, Berta Monleon Lopez, Ainhoa Serrano, Nekane Romero-García, Xavier Wittebole, Antonio M Dell'Anna, Camilla Gelormini, Eleonora Stival, Pilar Marcos Neira, Regina Roig Pineda, Lara Bielsa Berrocal, Maite Misis del Campo, Stepani Bendel, Jorge H Mejía-Mantilla, Ángela Marulanda, Wojciech Dabrowski, Rune Damgaard Nielsen, Markus Harboe Olsen, Helene Ravnholt Jensen, Ida Møller Larsen, Roberta Tallarico, Umberto Lucangelo, Maria Isabel Gonzales Perez, Carole Ichai, Karim Asenhoune, Karim Lakhal, Charlotte Fernandez-Canal, Samuel Gay, Marie Lebouc, David Bougon, Etienne Escudier, Michel Sirodot, Albrice Levrat, Alix Courouau, Jacques Duranteau, Aurore Rodrigues, Naima Makouche, Gilles Francony, Olivier Vincent, Perrine Boucheix, Clotilde Schilte, Anais Adolle, Thomas Gargadennec, Patricia Dias, Gwenaelle Desanglois, Alexia Meheut, Pauline Cam, Geert Meyfroidt, Liese Mebis, Alexandra Hendrickx, Pieetr Wouters, Sylvia Van Hulle, Alain D'Hondt, Marjorie Beumier, Marc Burgeois, Olivier Simonet, Frederic Vallot, Pablo Centeno, Matias Anchorena, Ximena Benavente, Maximilian D'Onofrio, Nydia Funes, Antonio Barra de Oca, Gabriela Izzo, Charlotte Castelain, Filippo Soetens, Mario Arias, Diego Morocho, Manuel Jabaja, Diego Tutillo, Stan Popugaev, Celeste Dias, Elena Perez Solada, Pilar Justo, Amparo Lopez Gomez, Sara Alcantara, Francisco Chico, Maria Fernanda Garcia, Fabricio Picoita, Stela Velasco Eichler, Gabriela Nonticuri Bianchi, João Pedro Britz, Jaqueline Almeida Pimentel, Mário Sérgio Fernandes, Hedi Gharsallah, Zied Hajjej, Walid Samoud, Oleg Grebenchikov, Valery Likhvantsev, Elena Stroiteleva, Nikolaos Markou, Dimitra Bakali, Dionysia Koutrafouri, Ahmed Subhy Alsheikhly, Angelo Giacomucci, Sara Maccherani, Janneke Horn, Mohamed Elbahnasawy, Arezoo Ahmadi, Lien Decaesteker, Daphne Decruyenaere, Ruth Demeersseman, Yves Devriendt, Karen Embo, Ditty van Duijn, Patricia Ormskerk, Melanie Glasbergen-van Beijeren, Hassane Njimi, Alain Cariou, Christophe Lelubre, Giuseppe Ristagno, Nino Stocchetti, Mauro Oddo, Cathy De Deyne, Giuseppe Citerio
Journal: JAMA (2024)

Importance Blood transfusions are commonly administered to patients with acute brain injury. The optimal hemoglobin transfusion threshold is uncertain in this patient population. Objective To assess the impact on neurological outcome of 2 different hemoglobin thresholds to guide red blood cell transfusions in patients with acute brain injury. Design, Setting, and Participants Multicenter, phase 3, parallel-group, investigator-initiated, pragmatic, open-label randomized clinical trial conducted in 72 intensive care units across 22 countries. Eligible patients had traumatic brain injury, aneurysmal subarachnoid hemorrhage, or intracerebral hemorrhage; hemoglobin values below 9 g/dL within the first 10 days after injury; and an expected intensive care unit stay of at least 72 hours. Enrollment occurred between September 1, 2017, and December 31, 2022. The last day of follow-up was June 30, 2023. Interventions Eight hundred fifty patients were randomly assigned to undergo a liberal (transfusion triggered by hemoglobin &amp;amp;lt;9 g/dL; n = 408) or a restrictive (transfusion triggered by hemoglobin &amp;amp;lt;7 g/dL; n = 442) transfusion strategy over a 28-day period. Main Outcomes and Measures The primary outcome was occurrence of an unfavorable neurological outcome, defined as a Glasgow Outcome Scale Extended score between 1 and 5, at 180 days following randomization. There were 14 prespecified serious adverse events, including occurrence of cerebral ischemia after randomization. Results Among 820 patients who completed the trial (mean age, 51 years; 376 [45.9%] women), 806 had available data on the primary outcome, 393 in the liberal strategy group and 413 in the restrictive strategy group. The liberal strategy group received a median of 2 (IQR, 1-3) units of blood, and the restrictive strategy group received a median of 0 (IQR, 0-1) units of blood, with an absolute mean difference of 1.0 unit (95% CI, 0.87-1.12 units). At 180 days after randomization, 246 patients (62.6%) in the liberal strategy group had an unfavorable neurological outcome compared with 300 patients (72.6%) in the restrictive strategy group (absolute difference, −10.0% [95% CI, −16.5% to −3.6%]; adjusted relative risk, 0.86 [95% CI, 0.79-0.94]; P = .002). The effect of the transfusion thresholds on neurological outcome at 180 days was consistent across prespecified subgroups. In the liberal strategy group, 35 (8.8%) of 397 patients had at least 1 cerebral ischemic event compared with 57 (13.5%) of 423 in the restrictive strategy group (relative risk, 0.65 [95% CI, 0.44-0.97]). Conclusions and Relevance Patients with acute brain injury and anemia randomized to a liberal transfusion strategy were less likely to have an unfavorable neurological outcome than those randomized to a restrictive strategy. Trial Registration ClinicalTrials.gov Identifier: NCT02968654