TRACS
Trial question
Is restrictive perioperative transfusion strategy noninferior to liberal transfusion strategy in patients undergoing cardiac surgery?
Study design
Single center
Single blinded
RCT
Population
Characteristics of study participants
38.0% female
62.0% male
N = 502
502 patients (192 female, 310 male).
Inclusion criteria: adult patients undergoing elective cardiac surgery with cardiopulmonary bypass.
Key exclusion criteria: emergency procedure; LV aneurysm resection; inability to receive blood products; chronic anemia; low platelet count; hepatic dysfunction; ESRD.
Interventions
N=249 a restrictive strategy (blood transfusion when hematocrit < 24%).
N=253 a liberal strategy (blood transfusion when hematocrit < 30%).
Primary outcome
All-cause mortality and severe morbidity during hospital stay
11%
10%
11.0 %
8.3 %
5.5 %
2.8 %
0.0 %
A restrictive
strategy
A liberal
strategy
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in all-cause mortality and severe morbidity during the hospital stay (11% vs. 10%; AD 1%, 95% CI -6 to 4).
Secondary outcomes
No significant difference in death at day 30 (6% vs. 5%; AD 1%, 95% CI -19.45 to 21.45).
No significant difference in cardiac complications (24% vs. 21%; AD 3%, 95% CI -2.3 to 8.3).
Borderline significant increase in respiratory complications (11% vs. 11%).
Conclusion
In adult patients undergoing elective cardiac surgery with cardiopulmonary bypass, a restrictive strategy was noninferior to a liberal strategy with respect to all-cause mortality and severe morbidity during the hospital stay.
Reference
Ludhmila A Hajjar, Jean-Louis Vincent, Filomena R B G Galas et al. Transfusion requirements after cardiac surgery: the TRACS randomized controlled trial. JAMA. 2010 Oct 13;304(14):1559-67.
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