JAMA Publishes Groundbreaking FARES-II Study Confirming the Superior Hemostatic Efficacy of Octaplex® (4F-PCC) Over Frozen Plasma in Cardiac Surgery

Study findings support modern precision transfusion practices, optimizing blood product use and improving patient outcomes in line with Patient Blood Management (PBM) principles.

A Paradigm Shift in Cardiac Surgery Bleeding Management

Excessive bleeding occurs in up to 15% of cardiac surgery patients, leading to higher morbidity, mortality, and increased reliance on transfusion therapies. Frozen Plasma has long been the standard treatment for coagulopathic bleeding, despite its lack of robust evidence for hemostatic efficacy and associated risks, including anaphylaxis, Transfusion-Related Acute Lung Injury (TRALI), and Transfusion-Associated Circulatory Overload (TACO).

The FARES-II trial, led by Dr. Keyvan Karkouti, demonstrates that Octaplex® (4F-PCC) significantly improves hemostatic efficacy, reduces the need for additional blood transfusions, and offers safety advantages over FP. Octaplex® is a Four-Factor Prothrombin Complex Concentrate (4F-PCC) containing clotting factors II, VII, IX, and X, along with proteins C and S, providing a targeted approach to restoring coagulation in critical bleeding scenarios.

Clinical and Healthcare Impact

These findings provide compelling evidence to update transfusion protocols, positioning Octaplex® (4F-PCC) as the preferred treatment for hemostatic management in cardiac surgery.

“Given the magnitude of the treatment effect, using Octaplex® (4F-PCC) over Frozen Plasma (FP) in cardiac surgery will reduce severe bleeding, decrease reliance on allogeneic blood transfusions, and ease pressure on blood supply and hospital resources,”

said Dr. Keyvan Karkouti, lead investigator of the FARES-II trial.

Commenting on the significance of the study findings and the broader ramifications for the Canadian blood system and transfusion practices, Dr Jeannie Callum, co-investigator stated,

"For patients undergoing cardiac surgery this novel approach of using 4F-PCC is better and faster for patient care (reducing transfusion and kidney failure), mitigates the risk of future blood-borne pathogens, reduces workload on blood banks and clinicians in the cardiac operating rooms, and will reduce hospital costs. It is a win for everyone”

Dr. Oliver Hegener, Head of the International Business Unit, Critical Care at Octapharma AG, reinforced the clinical implications of the study:

“This is the first large-scale controlled trial confirming that Octaplex® (4F-PCC) not only improves hemostatic efficacy but also reduces transfusion needs and associated risks. With its superior efficacy and safety profile, these findings support integrating Octaplex® into standard bleeding management protocols for cardiac surgery patients.”

Advancing the Future of Patient Blood Management (PBM)

The FARES-II study challenges the long-standing reliance on Frozen Plasma as the standard of care, advocating for the adoption of Octaplex® (4F-PCC) as a safer, more effective alternative in cardiac surgery. By demonstrating superior hemostatic efficacy and a lower risk profile, Octaplex® aligns with modern PBM principles—optimizing blood product use, minimizing unnecessary transfusions, and enhancing patient safety.

Sri Adapa, General Manager of Octapharma Canada, emphasized the broader impact of the study, stating:

"The latest FARES-II study findings and the earlier results from FIBRES study (Fibryga® versus Cryoprecipitate in Cardiac surgery) represent a watershed moment in Patient Blood Management (PBM) and transfusion medicine in Canada. Together, these landmark trials provide the highest level of evidence supporting targeted coagulation factor replacement over traditional plasma transfusion in cardiac surgery. The impact is far-reaching—reducing reliance on allogeneic blood products, minimizing transfusion-related risks, and improving patient outcomes.
Octapharma Canada has played a pioneering role in these transformative studies, helping to redefine bleeding management algorithms not just in Canada, but globally. These findings demand attention from transfusion medicine specialists, hospital policymakers, funders, and Canada’s blood system leaders. It’s time for PBM initiatives to integrate this evidence into national and institutional transfusion protocols, ensuring the safest and most effective strategies for managing surgical bleeding."

Future research will explore the generalizability of these findings to other surgical settings, further expanding the role of Octaplex® (4F-PCC) in critical bleeding management.

Read full article on JAMA here.

Media Contact: Sri Adapa
General Manager
Octapharma Canada
info.canada@octapharma.com

References:

^{1. Salenger R, Arora RC, Bracey A, et al. Ann Thorac Surg. 2025;119(2):280-295. doi: 10.1016/j.athoracsur.2024.06.039}

^{2. 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}

^{3. Callum et al. Effect of fibrinogen concentrate vs cryoprecipitate on blood component transfusion after cardiac surgery - The FIBRES randomized clinical trial. JAMA 2019. doi:10.1001/jama.2019.17312. Published online October 21, 2019.}