MACE-ICH trial — DEMO SITE
MAnnitol for Cerebral oEdema after IntraCerebral Haemorrhage


EudraCT 2022-000283-22
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Room S/D2105, Stroke Trials Unit
School of Medicine, University of Nottingham
Queen's Medical Centre, Derby Road
Nottingham NG7 2UH, United Kingdom
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  • Serious Adverse Events (SAEs) — we have a legal responsibility to collect all SAEs occurring within the first 28 days after randomisation (including SARs/SUSARs/fatal SAEs).
  • Please remember that fatal SAEs and safety outcome events – thrombophlebitis, hyper-/hyponatraemia, pulmonary oedema, hypotension and renal impairment – need to be reported until the final month 6 follow-up, even if this is after 28 days.
  • Please assess if expected according to SmPC: https://medicines.org.uk/emc/product/1839/smpc
    Expectedness should only be assessed in events that are thought to be possibly/probably/definitely related to the IMP.
  • Investigators have a legal responsibility to report applicable SAEs to the chief investigator without delay, within 24 hours.

Latest recruiting hospitals
Nottingham TEST hospital, NOTTINGHAM, UK
Derby TEST hospital, DERBY, UK