Intracerebral haemorrhage (ICH) is the most feared complication in patients on vitamin K
antagonists (VKA). VKA related ICH occurs 8-10 times more frequently and the mortality is 2
times higher than in non-anticoagulated patients. Mortality may rise up to 67%. The higher
mortality rate may in part be due to the higher rate of haematoma expansion (HE) over a
longer period after symptom onset. International guidelines recommend treatment of VKA-ICH
with prothrombin complex (PCC) or fresh-frozen plasma (FFP) both in combination with
Vitamin-K. But these recommendations are not based on randomized controlled trials. It is
known that these drugs lower the INR, and thus it is assumed that normalization of
coagulopathy may lead to haemostasis and reduction of HE. Safety and efficacy of these
treatments have never been studied in a prospective controlled trial.
The investigators' questions are: How potent are PCC and FFP in normalization of the INR?
What is the safety profile of each of these drugs?