MACE-ICH trial
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
Queen's Medical Centre, Nottingham, UK
The Royal London Hospital, London, UK
Addenbrooke's Hospital, Cambridge, UK
Aberdeen Royal Infirmary, Aberdeen, UK
Royal Devon and Exeter, Exeter, UK
Yeovil Hospital, Yeovil, UK
Morriston Hospital, Swansea, UK
  
Average time to randomisation (last 6 months)
# Hours Hospital
8 13.5 Queen's Medical Centre, Nottingham, UK
3 14.5 Yeovil Hospital, Yeovil, UK
4 26.6 Addenbrooke's Hospital, Cambridge, UK
2 30.1 Aberdeen Royal Infirmary, Aberdeen, UK
3 30.1 Royal Devon and Exeter, Exeter, UK
2 52.2 The Royal London Hospital, London, UK
Documents