Octapharma Announces Superior Haemostatic Efficacy of Four-Factor Prothrombin Complex Concentrate over Frozen Plasma in Cardiac Surgical Bleeding

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The Journal of the American Medical Association (JAMA) has published the positive findings from the FARES-II study, a Phase III clinical trial which demonstrated that four-factor prothrombin complex concentrate (4F-PCC) offers superior haemostatic efficacy compared to Frozen Plasma (FP) in patients experiencing excessive bleeding during cardiac surgery. Conducted across 12 leading hospitals in Canada and the United States, the study found that octaplex®/Balfaxar® (4F-PCC) improved haemostatic outcomes by 17.6% over FP, without increasing thromboembolic risk—presenting a more effective alternative for managing coagulation factor deficiencies in cardiac surgical patients.

The FARES-II study was jointly sponsored by the Canadian Institutes of Health Research (CIHR) and Octapharma, the manufacturer of the 4F-PCC used in the trial. This multicentre, randomised, controlled study evaluated 420 cardiac surgery patients who experienced excessive bleeding and were supported by a heart-lung bypass machine.

Read the full article on JAMA here.

A Paradigm Shift in the Management of Cardiac Surgical Bleeding

Excessive bleeding affects up to 15% of cardiac surgery patients, contributing to greater morbidity and mortality and increasing dependence on transfusion therapies. While Frozen Plasma has long been the standard treatment for coagulopathic bleeding, it is not supported by strong evidence of haemostatic efficacy and carries notable risks—including anaphylaxis, Transfusion-Related Acute Lung Injury (TRALI), and Transfusion-Associated Circulatory Overload (TACO).

The FARES-II findings provide compelling evidence to revise existing transfusion protocols, recommending octaplex®/Balfaxar® (4F-PCC) as the preferred treatment for haemostatic management in cardiac surgery.

“Given the magnitude of the treatment effect, using octaplex®/Balfaxar® (4F-PCC) over Frozen Plasma (FP) in cardiac surgery will reduce severe bleeding, decrease reliance on allogeneic blood transfusions, and ease pressure on blood supplies and hospital resources,” said Dr Keyvan Karkouti, lead investigator of the FARES-II trial.

Dr Oliver Hegener, Head of the International Business Unit, Critical Care at Octapharma AG, underscored the clinical implications of the study:
“This is the first large-scale controlled trial confirming that octaplex®/Balfaxar® (4F-PCC) not only improves haemostatic efficacy but also reduces transfusion requirements and associated risks. With its superior efficacy and safety profile, these findings support the integration of octaplex®/Balfaxar® into standard bleeding management protocols for cardiac surgery patients.”

Advancing Haemostatic Care in Cardiac Surgery

“The publication of FARES-II further validates 4F-PCC as the superior choice for bleeding management in cardiac surgery,” said Olaf Walter, Board Member at Octapharma. “Combined with the established evidence for fibryga® in this setting, Octapharma now offers a strong foundation for a tailored, concentrate-based approach that advances both patient care and healthcare efficiency.”

Enabled in a strong international research collaboration this is the next landmark result that allows further advancement in personalised bleeding management, reaffirming Octapharma’s unwavering commitment to improve patient safety and driving better clinical outcomes.