A four-factor prothrombin concentrate is significantly better than frozen plasma in controlling bleeding during heart surgery, according to a major new North American study.
Ten Canadian sites along with two US centres took part in the randomised trial, reported at the recent American College of Cardiology Conference in Chicago, and also in the Journal of the American Medical Association (JAMA).
The researchers report that the prothrombin concentrate nearly halved major bleeding events. The concentrate does not contain all the clotting factors found in plasma – but researchers hoped it might reduce the side effects associated with using the frozen product.
420 patients with excessive bleeding during heart surgery took part in the study. The participants had a median age of 66, and 74% were men. As well as a significant reduction in bleeding, the concentrate, 4F-PCC, was associated with a 29% reduction in blood transfusions.
The concentrate was also linked to a 25% reduction in serious adverse events and a 45% reduction in acute kidney injury.
Study leader Professor Keyvan Karkouti, professor of anesthesiology at the University of Toronto, Canada, said: “The results suggest that using 4F-PCC to manage excessive bleeding during cardiac surgery potentially has substantial benefits for patients and the health care system by relieving pressure on the blood supply and other hospital resources.
“Using 4F-PCC instead of frozen plasma could significantly reduce the need for frozen plasma in cardiac surgery.”
Professor Kenichi Tanaka from the University of Oklahoma, USA, who co-led the study in the US, said: “The finding that 4F-PCC may serve as a more effective alternative to frozen plasma in controlling surgical bleeding is a game-changer.
“4F-PCC can be given to patients with any blood type; we won’t need to keep as many blood-type specific frozen plasmas for heart surgery patients. With better bleeding control, we may consume less resources in the ICU.”
Source:
Karkouti K, Callum JL, Bartoszko J, Tanaka KA, Knaub S, Brar S, Ghadimi K, Rochon A, Mullane D, Couture EJ, Lin Y, Harle C, Zeller M, Tran DTT, Solomon C, Rao V, Law M, Butt AL, Chen EP, Martins MR, Saha T, Shih AW, Vézina MC, Moussa F, Pereira Cezar Zamper R, Syed S, Buyukdere H, Werner S, Grewal D, Wong D, Vandyck KB, Tanzola R, Hughes B, Royer O, Wong S, Levy JH; for the FARES-II Study Group. (2025) “Prothrombin Complex Concentrate vs Frozen Plasma for Coagulopathic Bleeding in Cardiac Surgery.” Journal of the American Medical Association, 29 March 2025, doi: 10.1001/jama.2025.3501.
Link: https://jamanetwork.com/journals/jama/fullarticle/2832096
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