Octapharma USA: JAMA Publishes Results for Investigational Four-Factor Prothrombin Complex Concentrate in Cardiac Surgical Bleeding

PARAMUS, N.J., April 2, 2025 /PRNewswire/ -- Octapharma USA announced the Journal of the American Medical Association (JAMA) has published results from a Phase III clinical trial, which observed non-activated four factor prothrombin complex concentrate (4F-PCC) was statistically superior to the standard therapy, frozen plasma, in patients experiencing excessive bleeding during cardiac surgery. The journal article noted that in the study 4F-PCC was more effective in stopping bleeds and caused fewer adverse events.

"Four-factor PCC reduced the relative risk of patients experiencing a major bleeding event by more than 40% compared to the standard treatment," said Kenichi Tanaka, M.D., Professor and Chair of Anesthesiology with the University of Oklahoma Health Sciences College of Medicine. "This study may encourage the medical community to reevaluate North American practices and guidelines for managing excessive bleeding in patients after complex cardiovascular surgery, which rely on multiple units of frozen plasma."

The FARES-II study (ClinicalTrials.gov Identifier: NCT05523297) was sponsored by the Canadian Institutes of Health Research (CIHR) and Octapharma, which manufactures the 4F-PCC used in the clinical trial. The multicenter, randomized, controlled study conducted at 12 hospitals in the United States and Canada observed 420 cardiac surgery patients experiencing excessive bleeding and utilizing a heart-lung bypass machine.

Cardiac Surgical Bleeding
Approximately 15% of patients undergoing cardiac surgery experience excessive bleeding that leads to depletion of clotting factors. Transfusion of frozen plasma is the standard treatment for excessive bleeding in cardiac surgery patients. More than two million plasma transfusions occur every year in the United States, about 20% of which occur during cardiac surgery. Before a transfusion can occur, frozen plasma must be thawed and matched to the patient's blood type. Alternative therapies include purified factor concentrates which are derived from pooled plasma and contain specific clotting factors and inhibitors to help stop bleeding.

"We appreciate that the prestigious Journal of the American Medical Association has shared this exciting news for patients undergoing complex cardiac procedures," said Octapharma USA President Flemming Nielsen. "Octapharma is committed to advancing critical care treatment for patients. We intend to file for FDA approval of this indication in the near future."

About FARES-II – Factor Replacement in Surgery
The study's primary endpoint was hemostatic response, the lack of any required interventions to stop bleeding from 60 minutes to 24 hours after treatment initiation. A second therapy dose could be given if medically indicated within 24 hours of therapy initiation. If further treatment was needed, all patients received frozen plasma. Secondary outcomes included chest tube drainage and allogeneic blood transfusions.

The median age of study patients was 66 and 74% were men as women are less likely to undergo cardiac surgery. Patients were randomized to receive fixed dosing of 4F-PCC or frozen plasma in the operating room. The 4F-PCC group had significantly higher hemostatic effectiveness (77.9% vs. 60.4%), lower chest tube drainage, and fewer allogeneic blood product units transfused.

Patients receiving 4F-PCC were 49% less likely than those receiving frozen plasma to experience severe or massive bleeding during the primary 24-hour observation period. Patients treated with 4F-PCC were 44% less likely than those treated with frozen plasma to need additional intervention to stop bleeding within 30 days of treatment. The 4F-PCC group needed 29% fewer blood transfusions than the frozen plasma patients.

Adverse outcome rates were similar, however, patients receiving 4F-PCC were 25% less likely to have a serious adverse event and 45% less likely to experience acute kidney injury compared to the frozen plasma group.

Octapharma continues to invest in research of 4F-PCC and is currently recruiting patients for LEX-210, a study observing patients with acute major bleeding on direct oral anticoagulants (DOAC) therapy. For more information, please visit ClinicalTrials.gov. (ClinicalTrials.gov Identifier: NCT04867837).

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 employees worldwide to support the treatment of patients in 118 countries with products across three therapeutic areas: Immunotherapy, Hematology 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 190 plasma donation centers across Europe and the US. Octapharma has over 40 years of experience in patient care. The company's American subsidiary, Octapharma USA, is located in Paramus, N.J. For more information, please visit octapharmausa.com.

OCTA-0443

SOURCE Octapharma