Haematoma expansion and vitamin K antagonist reversal – Authors' reply

The results of our study cannot be used to explain a dose-dependent association with thromboembolism because most of the patients in the FFP group received PCC after 3 h. Our findings are in accord with findings from other studies of vitamin K antagonist reversal in patients needing urgent surgical or invasive interventions or in patients with ICH.3,4 We agree that more data are needed to confirm the clinical benefit of PCC for VKA-ICH. [...]in view of the other clinical trials investigating a potential benefit of haemostatic agents or blood pressure reduction in spontaneous ICH, another trial on VKA-ICH with a clinical endpoint would need a very large number of patients, and some experts might question the ethical justification after the results of our proof-of-concept trial.