In this episode, I’ll discuss the European Society of Intensive Care Medicine’s recommendations on using PCC in bleeding critically ill adults.
The journal Intensive Care Medicine has recently published a clinical practice guideline from the European Society of Intensive Care Medicine on transfusion strategies in bleeding critically ill adults.
While they do address the use of prothrombin complex concentrates, they make no recommendation for the use of PCC versus plasma alone in massively bleeding patients due to very low certainty of evidence from observational studies only.
The guideline authors assessed studies using PCC to treat bleeding in patients with cardiac surgery, trauma, liver transplant and traumatic brain injury. They provided insight on the available data as follows:
For cardiac surgery, none of the relevant patient outcomes differed between arms. There is a reduction in RBC transfusions in favour of the PCC arm, but chest tube output was not different. For trauma, pooling of data suggests a decrease in mortality, but this was found in a single study only. Of note, all trauma studies reported a decrease in transfusion requirements in the PCC arm, which is congruent with a mortality benefit. However, there were considerable differences in the comparator arms, hampering any recommendation. For liver transplant and TBI, there was insufficient data.
The main problem with the observational studies the guideline authors analyzed was that the risk of bias was judged to be high. This bias comes from the severity of bleeding not being adequately measured in the available studies, leaving only a very low certainty of the effect of PCC on outcomes in bleeding critically ill adults.
There was not a finding of increased harm with PCC use, including no increase in thromboembolic events in the group of patients exposed to PCC. It is this lack of apparent harm that resulted in there not being a recommendation against the use of PCC>.
The guideline authors also describe how the cost-effectiveness of using PCC to treat bleeding is unknown, and perhaps most importantly that there is an overall lack of knowledge on potential conflict of interest related to funding sources of the available studies.
It is likely that the only role for PCC use in bleeding at this time is in the context of a clinical trial until there is sufficient data available to judge the efficacy and safety of PCC in bleeding critically ill patients.
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