Background Spontaneous intracerebral haemorrhage yearly affects over 6000 patients in the Netherlands. It is the deadliest stroke subtype, with a 30-day case-fatality of 40%. Of patients surviving, only few gain independence. However, effective treatment options are still lacking. This is reflected in the prognosis which has not improved over the last 30 years. Inflammation is known to play a vital role in the development of secondary brain injury related to intracranial haemorrhage. The release of blood products in the brainparenchyma leads to an activation of the immune system. This subsequently leads to destruction of the blood brain barrier and the formation of perihematomal oedema. Among the released cytokines, interleukin 1 beta (IL-1β) has a pivotal role. IL-1β is antagonized by the naturally occurring interleukin-1 receptor antagonist (IL-1Ra) through competitive binding to the IL-1 receptor. Recombinant human IL-1Ra (anakinra) is available for treatment of rheumatoid arthritis, other inflammatory diseases and has been studied in acute sepsis. We hypothesize that anakinra safely reduces secondary brain injury after spontaneous intracerebral haemorrhage, and that is effect is dose-dependent.
Aim The aim of ACTION is to determine the effect of anakinra on the development of perihaematomal oedema, compared to standard medical management. In an exploratory analysis, we will investigate whether this effect is dose-dependent. Furthermore, to study its effect on serum inflammatory markers, increased blood-brain-barrier leakage and functional outcome in patients with sICH.