Fresh frozen plasma versus prothrombin complex concentrate in patients with intracranial haemorrhage related to vitamin K antagonists (INCH): a randomised trial

Publication date: May 2016 Source:The Lancet Neurology, Volume 15, Issue 6 Author(s): Thorsten Steiner, Sven Poli, Martin Griebe, Johannes Hüsing, Jacek Hajda, Anja Freiberger, Martin Bendszus, Julian Bösel, Hanne Christensen, Christian Dohmen, Michael Hennerici, Jennifer Kollmer, Henning Stetefeld, Katja E Wartenberg, Christian Weimar, Werner Hacke, Roland Veltkamp Background Haematoma expansion is a major cause of mortality in intracranial haemorrhage related to vitamin K antagonists (VKA-ICH). Normalisation of the international normalised ratio (INR) is recommended, but optimum haemostatic management is controversial. We assessed the safety and efficacy of fresh frozen plasma (FFP) versus prothrombin complex concentrate (PCC) in patients with VKA-ICH. Methods We did an investigator-initiated, multicentre, prospective, randomised, open-label, blinded-endpoint trial. Patients aged at least 18 years with VKA-ICH who presented within 12 h after symptom onset with an INR of at least 2·0 were randomly assigned (1:1) by numbered sealed envelopes to 20 mL/kg of intravenous FFP or 30 IU/kg of intravenous four-factor PCC within 1 h after initial cerebral CT scan. The primary endpoint was the proportion of patients with INR 1·2 or lower within 3 h of treatment initiation. Masking of treatment was not possible, but the primary analysis was observer masked. Analyses were done using a treated-as-randomised approach. This trial is registered wi...
Source: The Lancet Neurology - Category: Neurology Source Type: research