Diseases & therapies
Octapharma announced today the results from a study, investigating whether four-factor prothrombin complex concentrate (4F-PCC) can be used as a substitute for frozen plasma (FP) for the treatment of bleeding during cardiac surgery.
The FARES study (NCT04114643), published in The Journal of the American Medical Association Network Open (Karkouti K et al. JAMA Network Open 2021; doi:10.1001/jamanetworkopen.2021.3936), was a phase 2, investigator-initiated randomised, parallel arm trial in adult patients requiring coagulation factor replacement therapy for bleeding during cardiac surgery.
Patients were randomised to receive either 4F-PCC (octaplex®) or FP for the first and second treatment up to 24 hours after surgery, with FP used for any subsequent treatment in both groups. All patients and outcome assessors were blinded to treatment allocation. The primary objectives of the trial were to assess the feasibility of the protocol and the suitability of 4F-PCC as a substitute for FP, based on the number of patients in the 4F-PCC group requiring additional FP. Secondary objectives included haemostatic effects and safety.
Of the 131 patients randomised in the study, 101 patients received treatment with either 4F-PCC or FP due to continued bleeding at the time of product arrival in the operating room.
Patients in the 4F-PCC group (N = 54) had a 44% (P < 0.001) lower exposure to allogeneic blood components than the FP group (N = 47), primarily due to a significantly lower requirement of additional FP transfusions (94% lower, P < 0.001)
4F-PCC treatment showed evidence of haemostatic superiority over FP, with reduced blood loss (38% lower after 12 hours, P < 0.001) and reduced requirement for red blood cell transfusions (47% lower, P = 0.001) in the 4F-PCC group
Occurrence of safety events and durations of intubation, intensive care unit stay, and hospital stay were similar between the two groups
The protocol was deemed feasible and important aspects of the protocol were adhered to in both treatment groups
“These results suggest that four factor PCC may be a suitable alternative to FP in cardiac surgery and highlight the feasibility and potential value of a larger randomised trial,” said Dr Keyvan Karkouti, lead author of the publication. “Reducing unnecessary plasma infusions and potentially improving bleeding control could help us to improve point of care, targeted bleeding management for patients, thereby improving patient outcomes and use of scarce healthcare resources.”
Patients who undergo cardiac surgery are at risk of coagulation factor depletion that may lead to excessive bleeding; approximately 15-20% of patients require FP transfusion for coagulation factor replacement.1-3 However, the need to replenish specific factors to target levels may require large infusion volumes of FP, and FP has been associated with complications such as transfusion-associated circulatory overload (TACO) and transfusion-related acute lung injury (TRALI).4 4F-PCCs, which offer a potential alternative for bleeding management, have reduced risk of pathogen transmission risk, do not require blood-type matching or thawing (enabling rapid administration), require lower volumes to achieve dose equivalence and can avoid transfusion-related complications.5-8 However, to date there have been no large randomised controlled trials comparing 4F-PCC and FP in bleeding cardiac surgery patients.
“Bleeding complications during cardiac surgical procedures are estimated to consume 10-15% of the global blood supply. Our 4F-PCC can play an integral role in modern management of perioperative bleeding by reducing blood loss and blood product use.”, explained Oliver Hegener, Head of IBU Critical Care at Octapharma. “The FARES study describes effective and safe bleeding management during cardiac surgery with octaplex® and adds important evidence how to improve patient care in this setting.”
The FARES study was conducted at two Canadian hospitals (University Health Network and Sunnybrook Health Sciences Centre) from September 2019 to July 2020. The results from the study support a larger randomised trial to compare the efficacy and safety of 4F-PCC and FP for bleeding management during cardiac surgery.
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 more than 9,000 people worldwide to support the treatment of patients in 118 countries with products across three therapeutic areas: Haematology, Immunotherapy, and Critical Care.
Octapharma has seven R&D sites and six state-of-the-art manufacturing facilities in Austria, France, Germany, Mexico and Sweden, and operates more than 160 plasma donation centres across Europe and the USA.
1. Kremers RM et al. Thromb Haemost 2016; 116:442-451
2. Triulzi D et al. Transfusion 2015; 55:1313-1319
3. Stanworth SJ et al. Transfusion 2011; 51:62-70
4. Pandey S and Vyas GN. Transfusion 2012; 52(Suppl.1):65S-79S
5. Ghadimi K et al. Anesth Analg 2016; 122:1287-1300
6. Roman M et al. Ann Thorac Surg 2019; 107:1275-1283
7. Fitzgerald J et al. Br J Anaesth 2018; 120:928-934
8. Percy CL et al. Blood Coagul Fibrinolysis 2015; 26:357-367
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Diseases & therapies