Mannitol for cerebral oedema after acute intracerebral haemorrhage (MACE-ICH): protocol for a prospective, randomised, open-label, blinded-endpoint phase IIb trial.

ABSTRACT:

Background

Acute intracerebral haemorrhage (ICH) is devastating with a 1 month mortality rate of ~40%. Cerebral oedema can complicate acute ICH and is associated with poor outcome. In patients with large ICH, the accompanying swelling increases mass effect and causes brain herniation. Mannitol, an osmotic diuretic, is used to treat cerebral oedema after traumatic brain injury, but its safety and efficacy in ICH is unclear. We aim to assess the feasibility of a phase II randomised, controlled trial of mannitol in patients with ICH with, or at risk of, cerebral oedema to inform a definitive trial.

Methods

The mannitol for cerebral oedema after acute intracerebral haemorrhage trial (MACE-ICH) aims to include 45 ICH participants from 10 UK sites with estimated largest diameter o

SUBMITTER: Krishnan K 

PROVIDER: S-EPMC12306335 | biostudies-literature | 2025 Jul

REPOSITORIES: biostudies-literature