Impact of Prothrombin Complex Concentrate and Fresh Frozen Plasma on Correction of Haemostatic Abnormalities in Bleeding Patients Undergoing Cardiac Surgery (PROPHESY Trial Results)

There is increased interest in the use of prothrombin complex concentrate (PCC) to treat bleeding in patients who do not require reversal of vitamin K antagonists. However, supporting data from randomised trials are scarce. Recently, we published the main results of a pilot randomised control trial (PROPHESY) in adult patients not taking vitamin K antagonists who developed bleeding within 24 h of cardiac surgery. Here, we describe in detail the coagulation abnormalities before administration of intervention(s) and during bleeding episodes, and we compare the correction of these abnormalities between different doses of interventions.

The recommended FFP dose for treatment of bleeding is 15–20 ml.kg^‐1, while the recommended dose for PCC in the same setting is 20–30 IU.kg^‐1: both these recommendations are based on observational studies, and this is the first randomised controlled trial to compare the two interventions in acquired bleeding disorders for patients not taking vitamin K antagonists. Future trials aiming to compare FFP with PCC in bleeding patients need to balance the doses for both, in order to demonstrate their real benefits and risks (the main reason for the chosen doses in this trial). Our results show that 1000 IU and 1500 IU for PCC are comparable with 4 units and 5 units of FFP, respectively, in correcting coagulation abnormalities in bleeding patients undergoing cardiac surgery, and large trials are now needed to evaluate the clinical benefits and risks of both.