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TRICS III (28-day outcomes)

Trial question
Is a restrictive RBC transfusion strategy noninferior to a liberal strategy in patients undergoing cardiac surgery?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
35.0% female
65.0% male
N = 4860
4860 patients (1721 female, 3139 male).
Inclusion criteria: adult patients undergoing cardiac surgery with cardiopulmonary bypass who had a moderate-to-high predicted risk of death, according to the European System for Cardiac Operative Risk Evaluation.
Key exclusion criteria: unable to receive blood products, declined blood products, involved in a preoperative autologous donation program, undergoing heart transplantation, having surgery solely for the insertion of a ventricular assist device, pregnant or lactating.
Interventions
N=2430 restrictive blood transfusion therapy (transfuse if hemoglobin level was < 7.5 g/dL, starting from induction of anesthesia).
N=2430 liberal blood transfusion therapy (transfuse if hemoglobin level was < 9.5 g/dL in the operating room or ICU or was < 8.5 g/dL in the non-ICU ward).
Primary outcome
Death, MI, stroke, or new-onset renal failure requiring dialysis at 28 days
11.4%
12.5%
12.5 %
9.4 %
6.3 %
3.1 %
0.0 %
Restrictive blood transfusion therapy
Liberal blood transfusion therapy
Difference not exceeding non-inferiority margin ✓
Difference not exceeding non-inferiority margin in death, MI, stroke, or new-onset renal failure requiring dialysis at 28 days (11.4% vs. 12.5%; OR 0.9, 95% CI 0.76 to 1.07).
Secondary outcomes
No significant difference in death (3% vs. 3.6%; OR 0.85, 95% CI 0.62 to 1.16).
Conclusion
In adult patients undergoing cardiac surgery with cardiopulmonary bypass who had a moderate-to-high predicted risk of death, according to the European System for Cardiac Operative Risk Evaluation, restrictive blood transfusion therapy was noninferior to liberal blood transfusion therapy with respect to death, MI, stroke, or new-onset renal failure requiring dialysis at 28 days.
Reference
Mazer CD, Whitlock RP, Fergusson DA et al. Restrictive or Liberal Red-Cell Transfusion for Cardiac Surgery. N Engl J Med. 2017 Nov 30;377(22):2133-2144.
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