FARES-II
Trial question
What is the effect of prothrombin complex concentrate in patients requiring coagulation factor replacement for bleeding during cardiac surgery?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
26.0% female
74.0% male
N = 420
420 patients (111 female, 309 male).
Inclusion criteria: patients requiring coagulation factor replacement for bleeding during cardiac surgery.
Key exclusion criteria: heart transplant; insertion or removal of ventricular assist devices; repair of a thoracoabdominal aneurysm; any concomitant noncardiac surgery.
Interventions
N=213 prothrombin complex concentrate (receipt of 1,500-2,000 IU after cardiopulmonary bypass while in the operating room and within 24 hours if necessary).
N=207 frozen plasma (receipt of 3-4 units after cardiopulmonary bypass while in the operating room and within 24 hours if necessary).
Primary outcome
Effective hemostatic response between 60 minutes and 24 hours after treatment
77.9%
60.4%
77.9 %
58.4 %
39.0 %
19.5 %
0.0 %
Prothrombin complex
concentrate
Frozen
plasma
Significant
increase ▲
NNT = 5
Significant increase in effective hemostatic response between 60 minutes and 24 hours after treatment (77.9% vs. 60.4%; RR 1.78, 95% CI 1.33 to 2.44).
Secondary outcomes
Significant decrease in ineffective global hemostatic response (26.3% vs. 40.5%; RR 0.65, 95% CI 0.49 to 0.86).
Significant decrease in severe or massive bleeding (14.1% vs. 27.5%; RR 0.51, 95% CI 0.34 to 0.76).
Significant decrease in least-squares mean transfusions including RBCs, platelets, and noninvestigational frozen plasma, ≤ 24 hours after cardiopulmonary bypass end (6.6 units vs. 9.3 units; AD -2.7 units, 95% CI -4.4 to -1).
Safety outcomes
No significant difference in at least 1 adverse event.
Significant differences in serious adverse events (36.2% vs. 47.3%), AKI (10.3% vs. 18.8%).
Conclusion
In patients requiring coagulation factor replacement for bleeding during cardiac surgery, prothrombin complex concentrate was superior to frozen plasma with respect to effective hemostatic response between 60 minutes and 24 hours after treatment.
Reference
Keyvan Karkouti, Jeannie L Callum, Justyna Bartoszko et al. Prothrombin Complex Concentrate vs Frozen Plasma for Coagulopathic Bleeding in Cardiac Surgery: The FARES-II Multicenter Randomized Clinical Trial. JAMA. 2025 Mar 29. Online ahead of print.
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