Prothrombin Complex Concentrate Shows Superior Efficacy Over Frozen Plasma in Cardiac Surgery Bleeding, reveals research
Researchers have discovered in a new study published in JAMA that prothrombin complex concentrate (PCC) has greater hemostatic effectiveness and safety benefits compared to frozen plasma for the treatment of coagulopathic bleeding during cardiac surgery. Bleeding that is excessive is a common and dangerous complication in cardiac surgery and is frequently accompanied by the need for replacement of coagulation factors. A recent study involving 12 US and Canadian hospitals identified that the use of PCC was associated with improved hemostatic response, fewer blood transfusions, and fewer serious adverse events. The study was conducted by Keyvan K. and colleagues.
The unblinded, noninferiority controlled, randomized clinical trial randomized 538 adults (≥18 years) undergoing coagulopathic bleeding after cardiopulmonary bypass. The trial took place from November 30, 2022, through May 28, 2024, and final follow-ups were done on June 28, 2024. Participants were allocated to two groups: 265 received PCC and 263 received frozen plasma. Dosing was based on weight, with PCC given at 1500 IU for patients ≤60 kg and 2000 IU for patients >60 kg, and frozen plasma given at 3 units for patients ≤60 kg and 4 units for patients >60 kg. Doses were allowed to be repeated within 24 hours, but only frozen plasma could be repeated after that time.
Key Findings
• Hemostatic Efficacy: PCC showed greater hemostatic effectiveness, 166 of 213 (77.9%) patients being hemostatically successful vs 125 of 207 (60.4%) patients in the frozen plasma group (difference: 17.6%; 95% CI, 8.7%-26.4%; P < 0.001).
• Blood Transfusion Need: Patients in the PCC group needed fewer transfusions, with a mean of 6.6 units of blood (95% CI, 5.7-7.7) vs 9.3 units (95% CI, 8.0-10.8) in the frozen plasma group (difference: 2.7 units; 95% CI, 1.0-4.4; P = 0.002).
• Serious Adverse Events: A lower number of patients in the PCC group (77; 36.2%) developed serious adverse events than in the frozen plasma group (98; 47.3%) (RR, 0.76; 95% CI, 0.61-0.96; P = 0.02).
• Acute Kidney Injury: Use of PCC was linked with decreased acute kidney injury, which developed in 22 patients (10.3%) compared with 39 patients (18.8%) in the frozen plasma group (RR, 0.55; 95% CI, 0.34-0.89; P = 0.02).
The study authors established that PCC offers superior hemostatic efficacy over frozen plasma with less demand for extra transfusions and decreased adverse events. With these advantages, PCC could be a more efficient way of addressing coagulopathic bleeding during cardiac surgery and has the potential to revolutionize clinical practices.
Reference:
Karkouti K, Callum JL, Bartoszko J, et al. Prothrombin Complex Concentrate vs Frozen Plasma for Coagulopathic Bleeding in Cardiac Surgery: The FARES-II Multicenter Randomized Clinical Trial. JAMA. Published online March 29, 2025. doi:10.1001/jama.2025.3501
