TRISS
Trial question
What is the effect of lower hemoglobin threshold for transfusion in patients with septic shock?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
47.0% female
53.0% male
N = 998
998 patients (467 female, 531 male).
Inclusion criteria: patients in the ICU who had septic shock and a hemoglobin concentration ≤ 9 g/dL.
Key exclusion criteria: declined transfusion, previous adverse reaction to transfusion, received blood transfusion in ICU, acute coronary syndrome, life-threatening bleeding, and acute burn injury.
Interventions
N=502 restrictive blood transfusion therapy (1 unit of leukoreduced red cells when hemoglobin level ≤ 7 g/dL).
N=496 liberal blood transfusion therapy (1 unit of leukoreduced red cells when hemoglobin level ≤ 9/dL).
Primary outcome
Death at 90 days
43%
45%
45.0 %
33.8 %
22.5 %
11.3 %
0.0 %
Restrictive blood transfusion
therapy
Liberal blood transfusion
therapy
No significant
difference ↔
No significant difference in death at 90 days (43% vs. 45%; RR 0.94, 95% CI 0.78 to 1.09).
Secondary outcomes
No significant difference in use of life support at day 28 (16.1% vs. 19.9%; RR 0.77, 95% CI 0.54 to 1.09).
No significant difference in ischemic events in the ICU (7.2% vs. 8%; RR 0.9, 95% CI 0.58 to 1.39).
Safety outcomes
No significant differences in severe adverse reaction (0% vs. 0.2%, p=1.00).
Conclusion
In patients in the ICU who had septic shock and a hemoglobin concentration ≤ 9 g/dL, restrictive blood transfusion therapy was not superior to liberal blood transfusion therapy with respect to death at 90 days.
Reference
Holst LB, Haase N, Wetterslev J et al. Lower versus higher hemoglobin threshold for transfusion in septic shock. N Engl J Med. 2014 Oct 9;371(15):1381-91.
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