Canadian Study Reveals New Approach to Managing Bleeding Risks in Patients on FXa Inhibitors with the prophylactic use of octaplex® During Emergency Surgery

Toronto, August 29, 2024 – A groundbreaking Canadian study, "PROXY," published in The Journal of Thrombosis and Haemostasis (JTH), offers new hope for patients on oral factor Xa (FXa) inhibitors facing emergency surgery. The study demonstrates that preoperative administration of a fixed dose of 4-factor prothrombin complex concentrate (4F-PCC, Octaplex®) can effectively prevent excessive bleeding without increasing the risk of thrombotic events, potentially transforming patient care and surgical outcomes.

Revolutionizing Patient Care

Patients on FXa inhibitors, such as rivaroxaban and apixaban, often face significant bleeding risks during urgent surgical procedures. Until now, the standard approach has involved either delaying surgery to allow the drug to clear from the system or proceeding with surgery and managing bleeding complications as they arise. Both options carry serious risks.

The PROXY trial, led by Professor Sam Schulman across three Canadian centers, offers a compelling alternative. The study found that administering a fixed dose of 4F-PCC, Octaplex® before surgery normalized hemostasis in most patients, allowing them to undergo emergency surgery safely. This approach could be life-changing for patients who would otherwise face high risks from delayed surgery or uncontrolled bleeding.

Clinical Impact

“Patients on oral FXa inhibitors would almost certainly experience bleeding complications during major surgery if no preventive measures are taken,” said Professor Schulman. “Our study shows that 4F-PCC Octaplex® can normalize hemostasis, allowing for safe emergency surgery. This is a critical advancement in patient care.”

“Our research partnerships with Canada’s leading healthcare institutions continue to generate world class evidence that support innovative transfusion practices and bring evidence-based improvements to the Canadian blood system” said Sri Adapa, General Manager of Octapharma Canada. “We remain committed to advancing patient blood management (PBM) initiatives that promote tailored, patient-centric approaches to bleeding management.”

The results indicate that 4F-PCC could become a standard preoperative treatment for patients on FXa inhibitors, improving surgical outcomes and reducing complications. The study's full results are available online, with open access in the Journal of Thrombosis and Haemostasis (JTH)

New Horizons

While the findings are promising, larger trials are necessary to confirm the results and establish 4F-PCC as a standard of care for patients on FXa inhibitors requiring emergency surgery. An ongoing confirmatory trial further explores the effectiveness and safety of Octaplex® in acute bleeding under DOACs, to facilitate tailored bleeding management.

About Octapharma
Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines. Octapharma employs nearly 12,000 people worldwide to support the treatment of patients in 118 countries with products across three therapeutic areas: Immunotherapy, Haematology and Critical Care. Octapharma has seven R&D sites and five state-of-the-art manufacturing facilities in Austria, France, Germany and Sweden, and operates more than 195 plasma donation centres across Europe and the US. Octapharma has 40 years of experience in patient care.

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