A pragmatic pilot randomized phase II controlled trial of Prothrombin Complex Concentrates (PCC) versus Fresh Frozen Plasma (FFP) in adult patients who are Undergoing Heart Surgery (PROPHESY)

Background Fresh Frozen Plasma (FFP) is the accepted standard treatment for clotting factor replacement in bleeding patients during, or immediately after cardiac surgery. In the United Kingdom (UK) prothrombin complex concentrate (PCC) is not licensed in this setting although it is being used in Europe, because it has a higher concentration of clotting factor levels, and it can be administered rapidly and in small volume, resulting in less volume overload during cardiac surgery. Methods PROPHESY is a pragmatic single-centre, open-label, randomized, controlled pilot trial that will assess whether it is feasible to perform a large trial in the future that will compare PCC versus FFP in patients who are bleeding (not on warfarin) and who require blood transfusion. Over a 15-month period, 50 patients will be randomized to PCC versus FFP if they develop active bleeding within 24 hours of cardiac surgery, and for whom the clinician has decided to administer FFP for treatment of bleeding. Standard laboratory and Point-of-Care assessments will be performed as per routine practice, and additional research blood samples will be taken at three time-points to assess haemostasis. Subjects will be assessed daily up to hospital discharge or 30 days or death (whichever occurs first) and will be followed up for 90 days after surgery to assess for thromboembolic complications, and hospital re-admission since discharge. Quality of life assessment will be performed pre-surgery and at 90 days. We will also perform qualitative research with clinical experts and patients to explore the understanding and experience with the interventions, and adherence to study procedures and protocol. Discussion There have been no randomized control trials that have compared the safety and efficacy of FFP versus PCC in cardiac surgery in patients who are bleeding. This pilot study will assess if individual components of a large trial are deliverable to assess the safety and efficacy of the two blood products in the future.