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American Heart Association

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Final ID: OGCTP38

MAnnitol for Cerebral oEdema after IntraCerebral Haemorrhage (MACE-ICH): a feasibility trial

Abstract Body: Introduction
After spontaneous intracerebral haemorrhage (ICH), a key question is the management of significant cerebral oedema, estimated to affect ~1,500 patients in the UK each year. Mannitol, an osmotic diuretic, is readily available and licensed to treat cerebral oedema. MACE-ICH will determine the feasibility of screening, assessing eligibility, approaching potential participants, randomisation, administering mannitol and completing follow-up for acute ICH patients with cerebral oedema, or at risk of cerebral oedema, to inform a definitive trial.

Methods
MACE-ICH is a multicentre, prospective, randomised, open-label, blinded-endpoint trial and will recruit adults with spontaneous ICH with estimated largest diameter >2cm, presenting within 72 hours of onset with, or at risk of cerebral oedema with or without mass effect (limited GCS score <9 (eye opening and motor only) and NIHSS>8). Participants will be randomised (1:1:1) to receive either: (a) 1g/kg 10% single-dose mannitol infusion at 10ml/min with standard care; (b) 1g/kg 10% mannitol at 10 ml/min, followed by a second dose at 24 hours (if serum osmolality <320mOsm/Kg and sodium <160mEq/L after the first dose) with standard care; or (c) standard care alone.

Results
45 participants will be recruited from ten UK, NHS hospitals providing acute stroke services. As of 17th October 2024, 23 participants have been recruited to this study.

Conclusions
MACE-ICH will inform the design and conduct of an adequately powered, pragmatic, prospective multicentre randomised controlled trial testing mannitol as a treatment for cerebral oedema in spontaneous ICH.
  • Bath, Philip  ( University of Nottingham , Nottingham , United Kingdom )
  • Roffe, Christine  ( Keele University , Stoke-on-trent , United Kingdom )
  • Sprigg, Nikola  ( University of Nottingham , Nottingham , United Kingdom )
  • Woodhouse, Lisa  ( University of Nottingham , Nottingham , United Kingdom )
  • Krishnan, Kailash  ( The University of Nottingham , Nottingham , United Kingdom )
  • Buck, Amanda  ( University of Nottingham , Nottingham , United Kingdom )
  • Dawson, Jesse  ( UNIVERSITY OF GLASGOW , Glasgow , United Kingdom )
  • Dineen, Robert  ( University of Nottingham , Nottingham , United Kingdom )
  • England, Tim  ( University of Nottingham , Derby , United Kingdom )
  • Havard, Diane  ( University of Nottingham , Nottingham , United Kingdom )
  • Hewson, David  ( University of Nottingham , Nottingham , United Kingdom )
  • Macleod, Mary  ( UNIVERSITY ABERDEEN , Aberdeen , United Kingdom )
  • Author Disclosures:
    Philip Bath: DO have relevant financial relationships ; Individual Stocks/Stock Options:CoMind:Active (exists now) ; Advisor:Roche:Past (completed) ; Advisor:Phagenesis:Past (completed) ; Individual Stocks/Stock Options:DiaMedica:Active (exists now) | Christine Roffe: DO NOT have relevant financial relationships | Nikola Sprigg: DO NOT have relevant financial relationships | Lisa Woodhouse: No Answer | Kailash Krishnan: No Answer | Amanda Buck: No Answer | Jesse Dawson: DO NOT have relevant financial relationships | Robert Dineen: DO NOT have relevant financial relationships | Tim England: DO NOT have relevant financial relationships | Diane Havard: DO NOT have relevant financial relationships | David Hewson: DO NOT have relevant financial relationships | Mary Macleod: DO NOT have relevant financial relationships
Meeting Info:
Session Info:

Ongoing Clinical Trials Posters

Thursday, 02/06/2025 , 07:00PM - 07:30PM

Poster Abstract Session

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