TRICS III (6-month follow-up)
Trial question
Is the restrictive strategy for RBC transfusion noninferior to a liberal strategy among patients undergoing cardiac surgery who were at moderate-to-high risk for death?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
35.5% female
64.5% male
N = 5243
5243 patients (1721 female, 3139 male)
Inclusion criteria: adult patients undergoing cardiac surgery with cardiopulmonary bypass who were at moderate-to-high predicted risk for death
Key exclusion criteria: unable to receive or refusal of blood products, involvement in a preoperative autologous pre-donation program, undergoing heart transplant or surgery solely for insertion of a ventricular assist device
Interventions
N=2430 restrictive transfusion strategy (red cell transfusion if the hemoglobin concentration < 7.5 g/dL intraoperatively or postoperatively)
N=2430 a liberal transfusion strategy (transfusion if the hemoglobin concentration < 9.5 g/dL in the ICU or < 8.5 g/dL in the non-ICU ward)
Primary outcome
Rate of death from any cause, myocardial infarction, stroke, or new-onset renal failure with dialysis occurring within 6 months after the initial surgery
17.4
17.1
17.4 %
13.0 %
8.7 %
4.3 %
0.0 %
Restrictive transfusion
strategy
A liberal transfusion
strategy
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in the rate of death from any cause, myocardial infarction, stroke, or new-onset renal failure with dialysis occurring within 6 months after the initial surgery (17.4% vs. 17.1%; OR 1.02, 95% CI 0.87 to 1.18)
Secondary outcomes
No significant difference in death at 6 months (6.2% vs. 6.4%; OR 0.95, 95% CI 0.75 to 1.21)
No significant difference in the rate of death from any cause, myocardial infarction, stroke, or new-onset renal failure with dialysis, emergency department visit, hospital readmission, or coronary revascularization occurring within 6 months after the initial surgery (43.8% vs. 42.8%; OR 1.04, 95% CI 0.93 to 1.17)
No significant difference in myocardial infarction at 6 months (7.3% vs. 7.3%; OR 0.99, 99% CI 0.79 to 1.24)
Safety outcomes
No significant differences in stroke, new-onset renal failure with dialysis, coronary revascularization.
Conclusion
In adult patients undergoing cardiac surgery with cardiopulmonary bypass who were at moderate-to-high predicted risk for death, restrictive transfusion strategy was noninferior to a liberal transfusion strategy with respect to the rate of death from any cause, myocardial infarction, stroke, or new-onset renal failure with dialysis occurring within 6 months after the initial surgery.
Reference
C David Mazer, Richard P Whitlock, Dean A Fergusson et al. Six-Month Outcomes after Restrictive or Liberal Transfusion for Cardiac Surgery. N Engl J Med. 2018 Sep 27;379(13):1224-1233.
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