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?
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
intravenous, repeated until INR ≤ 1.2
Heidelberg University Clinic
Heidelberg, Germany
INR ≤ 1.2 within 3 hours after start of drug infusion
Time frame: 3 hours
Safety: Number of thromboembolic events
Time frame: 90 days
Efficacy: Percentage of volume increase
Time frame: 24 hours
Clinical outcome
Time frame: day 90
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