Ravulizumab (ALXN1210) versus eculizumab in adults with paroxysmal nocturnal hemoglobinuria: pharmacokinetics and pharmacodynamics observed in two Phase 3 randomized, multicenter studies

RationaleIntracerebral haemorrhage caused ˜3 million deaths worldwide in 2015. Two‐thirds of survivors are left dependent on others. Roughly one third of patients are taking antiplatelet drugs at the time of intracerebral haemorrhage in high‐income countries, and this proportion has been increasing over time. Pre‐stroke antiplatelet drug use is associated with a 27% relative increase in one‐month case fatality compared to patients not using antithrombotic drugs. Platelet transfusion, tranexamic acid, and recombinant activated factor VII do not seem to improve outcome after antiplatelet‐associated intracerebral haemorrhage, but desmopressin has seemed promising in non‐randomised pilot studies.ObjectivesWe aim to assess the feasibility of screening, checking the eligibility, approaching, randomising, administering desmopressin or placebo, and completing follow‐up for patients with antiplatelet‐associated intracerebral haemorrhage. DesignWe aim to include 50 patients within 12 hours of spontaneous intracerebral haemorrhage onset, associated with oral antiplatelet drug(s) use in the preceding seven days. Exclusion criteria are: known secondary cause for intracerebral haemorrhage; risk of fluid retention associated with desmopressin; significant hypotension (SBP ConclusionThis is a feasibility trial, which will inform the design of a definitive trial.</div