TY - JOUR
T1 - Restrictive vs Liberal Transfusion Strategy in Patients With Acute Brain Injury
T2 - The TRAIN Randomized Clinical Trial
AU - Taccone, Fabio Silvio
AU - Rynkowski Bittencourt, Carla
AU - Møller, Kirsten
AU - Lormans, Piet
AU - Quintana-Díaz, Manuel
AU - Caricato, Anselmo
AU - Cardoso Ferreira, Marco Antonio
AU - Badenes, Rafael
AU - Kurtz, Pedro
AU - Søndergaard, Christian Baastrup
AU - Colpaert, Kirsten
AU - Petterson, Leticia
AU - Quintard, Herve
AU - Cinotti, Raphael
AU - Gouvêa Bogossian, Elisa
AU - Righy, Cassia
AU - Silva, Serena
AU - Roman-Pognuz, Erik
AU - Vandewaeter, Catherine
AU - Lemke, Daniel
AU - Huet, Olivier
AU - Mahmoodpoor, Ata
AU - Blandino Ortiz, Aaron
AU - van der Jagt, Mathieu
AU - Chabanne, Russell
AU - Videtta, Walter
AU - Bouzat, Pierre
AU - Vincent, Jean-Louis
AU - TRAIN Study Group
PY - 2024/11/19
Y1 - 2024/11/19
N2 - 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 <9 g/dL; n = 408) or a restrictive (transfusion triggered by hemoglobin <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.
AB - 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 <9 g/dL; n = 408) or a restrictive (transfusion triggered by hemoglobin <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.
KW - Adult
KW - Aged
KW - Blood Transfusion/methods
KW - Brain Injuries, Traumatic/blood
KW - Cerebral Hemorrhage/blood
KW - Female
KW - Glasgow Outcome Scale
KW - Hemoglobins/analysis
KW - Humans
KW - Intracranial Aneurysm/blood
KW - Male
KW - Middle Aged
KW - Subarachnoid Hemorrhage/blood
UR - http://www.scopus.com/inward/record.url?scp=85209251275&partnerID=8YFLogxK
U2 - 10.1001/jama.2024.20424
DO - 10.1001/jama.2024.20424
M3 - Journal article
C2 - 39382241
SN - 0002-9955
VL - 332
SP - 1623
EP - 1633
JO - JAMA
JF - JAMA
IS - 19
ER -