A Multicentre Observational Study of Prothrombin Complex Concentrate Therapy in Cardiac Surgery Patients

Abstract

Aim: This study aimed to assess the characteristics, transfusion events, and clinical outcomes of cardiac surgery patients treated with three-factor prothrombin complex concentrate (3F-PCC). Method: A retrospective observational study was performed in three cardiac surgery centres in Australia. We studied sequential cardiac surgeries and collected data on 3F-PCC, fresh frozen plasma (FFP) and red blood cell (RBC) use from blood banks and clinical outcomes from the Australian Society of Cardiothoracic Surgery database. We compared 3F-PCC treated to PCC-untreated patients. Results: For 1,698 patients, 254 (15%) received 3F-PCC, with a median dose of 2,000 IU (Interquartile range [IQR]: 1,000 to 2,000), administered almost exclusively in the operating theatre. After adjustment by overlap weighting, 3F-PCC was associated with a reduction in post-surgical FFP transfusions (Relative risk [RR]: 0.47; 95% confidence interval [CI] 0.29 to 0.77). Similarly, 14% of 3F-PCC patients needed ≥2 RBC units after surgery compared to 21% in controls (RR: 0.63; 95% CI 0.45 to 0.88). Both groups displayed similar safety profiles and clinical outcomes. However, pulmonary embolism occurred in 1.8% of 3F-PCC patients versus 0.8% of controls. Conclusions: In a multicentre study, 3F-PCC use during cardiac surgery was independently associated with a significantly reduction of postoperative FFP and RBC transfusions. A phase III trial of early PCC at 2,000 IU appears justified.