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A Multicentre Observational Study of Prothrombin Complex Concentrate Therapy in Cardiac Surgery Patients
Yukiko Hikasa1, Anis Chaba2, Christine Culliver3
1Department of Intensive Care, Austin Hospital, Melbourne, Vic, Australia.
Insights
Three-factor prothrombin complex concentrate (3F-PCC) use in cardiac surgery patients reduced the need for fresh frozen plasma and red blood cell transfusions. Early 3F-PCC administration at 2,000 IU warrants further investigation in clinical trials.
Area of Science:
- Cardiology
- Hematology
- Transfusion Medicine
Background:
- Cardiac surgery patients often require blood transfusions.
- Managing perioperative bleeding is crucial for patient outcomes.
Purpose of the Study:
- To evaluate the use and impact of three-factor prothrombin complex concentrate (3F-PCC) in cardiac surgery.
- To assess transfusion requirements and clinical outcomes in patients treated with 3F-PCC.
Main Methods:
- Retrospective observational study across three Australian cardiac surgery centers.
- Data collected on 3F-PCC, fresh frozen plasma (FFP), and red blood cell (RBC) transfusions.
- Comparison of outcomes between 3F-PCC treated and untreated patient groups.
Main Results:
- 15% of 1,698 patients received 3F-PCC (median 2,000 IU).
- 3F-PCC was linked to reduced postoperative FFP (RR 0.47) and RBC transfusions (RR 0.63).
- Similar safety profiles, but higher pulmonary embolism rates in the 3F-PCC group (1.8% vs 0.8%).
Conclusions:
- Multicenter data show 3F-PCC use is associated with significantly fewer postoperative FFP and RBC transfusions.
- Early administration of 3F-PCC at 2,000 IU is supported by these findings.
- A phase III trial is justified to confirm these results.
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.
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