Mannitol for stopping or preventing brain swelling (cerebral oedema) after stroke from bleeding in the brain (intracerebral haemorrhage): a feasibility study

Phase 2

Completed

• Conditions: Acute intracerebral haemorrhage (ICH); Nervous System Diseases

• Registration Number: ISRCTN15383301
• Lead Sponsor: ottingham University Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-18
• Study Completion: 2024-08-30
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

1. Adults (>18 years); spontaneous ICH confirmed by CT scan with estimated largest diameter > 2 cm;
2. 3. Cerebral oedema with or without evidence of mass effect;
4. At risk of developing oedema (limited GCS <9 (eye opening and motor only) and NIHSS>/=8);
5. Signed consent (patient, personal or professional representative or independent physician)

Exclusion Criteria

1. GCS<5; premorbid mRS >3;
2. Isolated subarachnoid haemorrhage;
3. Haemorrhage known to be from: trauma or venous thrombosis or arteriovenous malformation or brain tumour or transformation of cerebral Infarct or cerebral aneurysm or thrombolytic drug;
4. Known hypersensitivity to mannitol;
5. Severe renal failure (e-GFR<30ml/min or dialysis);
6. Cardiac failure;
7. Hypotension at baseline (SBP <90 mm Hg);
8. Anuria;
9. Patient unwilling to participate;
10. Geographical or other factors which prohibit follow-up;
11. Pre-existing comorbidity with pre-ictal life expectancy <6 months;
12. Severe dementia;
13. Planned for palliative care;
14. Severe hypernatremia (sodium >160 mmol);
15. Severe hyponatremia (sodium <125 mmol);
16. Women of child-bearing age with a positive pregnancy test at the time of admission or lactating;
17. Patients in whom peripheral intravenous cannula cannot be placed;
18. Planned neurosurgery

Study & Design

• Study Type: Interventional
• Study Design: Not specified