TRAIN
Trial question
What is the role of liberal versus restrictive transfusion strategy in patients with acute brain injury and anemia?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
45.0% female
55.0% male
N = 806
806 patients (362 female, 444 male).
Inclusion criteria: patients with traumatic brain injury, aneurysmal subarachnoid hemorrhage, or intracerebral hemorrhage with hemoglobin values < 9 g/dL within the first 10 days after injury and an expected ICU stay of at least 72 hours.
Key exclusion criteria: post-anoxic coma; epilepticus without underlying brain injury; CNS infections; known previous neurological disease causing significant cognitive and/or motor handicap; active and uncontrolled bleeding at the time of enrolment; pregnancy; medical need to correct anemia; do-not-escalate orders.
Interventions
N=393 liberal transfusion strategy (receipt of packed RBC transfusion triggered by a hemoglobin level < 9 g/dL).
N=413 restrictive transfusion strategy (receipt of packed RBC transfusion triggered by a hemoglobin level < 7 g/dL).
Primary outcome
Unfavorable neurological outcome at day 180
62.6%
72.6%
72.6 %
54.4 %
36.3 %
18.1 %
0.0 %
Liberal transfusion
strategy
Restrictive transfusion
strategy
Significant
decrease ▼
NNT = 10
Significant decrease in unfavorable neurological outcome at day 180 (62.6% vs. 72.6%; RR 0.86, 95% CI 0.79 to 0.94).
Secondary outcomes
No significant difference in death at day 28 (20.7% vs. 22.5%; RR 0.95, 95% CI 0.74 to 1.22).
No significant difference in death and any organ failure at day 28 (80.1% vs. 78.3%; RR 1.03, 95% CI 0.97 to 1.1).
No significant difference in mean intensive unit length of stay (21.4 days vs. 22.5 days; AD -1.19 days, 95% CI -3.34 to 0.97).
Safety outcomes
No significant differences in sepsis, severe hypotension, and ARDS.
Significant difference in cerebral ischemia (8.8% vs. 13.5%).
Conclusion
In patients with traumatic brain injury, aneurysmal subarachnoid hemorrhage, or intracerebral hemorrhage with hemoglobin values < 9 g/dL within the first 10 days after injury and an expected ICU stay of at least 72 hours, liberal transfusion strategy was superior to restrictive transfusion strategy with respect to unfavorable neurological outcome at day 180.
Reference
Fabio Silvio Taccone, Carla Rynkowski Bittencourt, Kirsten Møller et al. Restrictive vs Liberal Transfusion Strategy in Patients With Acute Brain Injury: The TRAIN Randomized Clinical Trial. JAMA. 2024 Nov 19;332(19):1623-1633.
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