Acute intracerebral haemorrhage (ICH) Nervous System Diseases
Conditions
Interventions
There are three arms in the MACE-ICH study, and patients are randomised into one of the arms via a 1:1:1 online, bespoke, randomisation system, built specifically for the purpose of the trial. The ran
blood tests performed on day 1
CT head scan on day 5 (±2)
day 28 follow-up by research team
day 180 follow-up by central trial office (MACE-ICH team based in Nottingham).
2. Two doses of mannitol: Manntiol (1g/kg of 10% IV infusion at 10ml/min) + Standard care on Day 0
if blood tests, specifically serum osmolality, are stable then participants receive a second dose of mannitol (1g/kg of 10% IV infusion at 10ml/min)
blood tests done again on day 2
day 180 follow-up by central trial office (MACE-ICH team based in Nottingham).
3. Standard care (e.g., at the clinician's discretion: IV fluids, nasogastric tube, other medications)
day 180 follow-up by central trial office (MACE-ICH team based in Nottingham).
Sponsors
Nottingham University Hospitals NHS Trust
Eligibility
Sex/Gender
All
Age
18 Years to 110 Years
Inclusion criteria
Inclusion criteria: 1. Adults (>18 years); spontaneous ICH confirmed by CT scan with estimated largest diameter > 2 cm; 2. /=8); 5. Signed consent (patient, personal or professional representative or independent physician)
Exclusion criteria
Exclusion criteria: 1. GCS3; 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-GFR160 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Number of patients: screened and eligible: collected on screening logs that are requested from sites on a monthly basis. 2. Number of eligible patients recruited and reasons for not recruiting: collected on screening logs that are requested from sites on a monthly basis. 3. Proportion of eligible patients who received allocated treatment and reasons for non-allocation: This can be retrieved from the bespoke MACE-ICH database, whenever it is needed. 4. Recruitment rate derived from the sample size: This can be retrieved from the bespoke MACE-ICH database, and this data can also be collected on screening logs that are requested from sites on a monthly basis. 5. Treatment adherence: This can be continuously monitored, throughout the duration of the trial, within the bespoke MACE-ICH database. 6. Retention rate (number of participants with complete follow-up data at 180 days as a proportion of those randomised): This can be continuously monitored, throughout the duration of the trial, within the bespoke MACE-ICH database. All completed follow-ups will be visible in the MACE-ICH bespoke database. 7. Number of patients with outcome data and reasons for non-availability: This data will be continuously monitored within the MACE-ICH bespoke database. Any reasons for missing data will be collected by the monitor. 8. Effectiveness of blinded follow-up: Day-180 follow-up data will be checked by the trial monitor. 9. Incidence and type of adverse events, protocol violations and trial withdrawal. This data will be continuously monitored within the MACE-ICH bespoke database, in conjunction with any adverse event/protocol violation logs that are available to monitor. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Laboratory tests (U&E’s; e-GFR; serum osmolality): measured on days 1 and 2 (day 2 only for patients randomised to receive two doses of mannitol) 2. Participants' levels of consciousness are measured using the Glasgow Coma Scale (GCS) on day 5+/-2, 3. Participants' stroke severity is measured using the National Institutes Health Stroke Scale (NIHSS) on day 5+/-2, 4. Number of patients who had urinary tract infection collected from medical records on day 5±2 and day 28, 5. Number of patients who had sepsis collected from medical records on day 5±2 and day 28, 6. Mortality collected from medical records on day 5±2 and day 28 7. Participants' disability is measured using the Barthel Index on day 180, 8. Participants' mood is measured using the Zung depression scale [ZDS] on day 180, 9. Participants' cognition is measured using the TICS-M assessment on day 180, 10. Participants' quality of life is measured using the Euro-[EQ] QOL and EQ-VAS, on day 180, 11. Health economic assessment is measured using the EQ-5D questionnaire on day 180, 12. Participants' death or dependency is measured using the modified Rankin scale (mRS) on day 180, 13. Participants' length of stay in hospital is collected from the participant on the day-180 telephone questionnaire, 14. Participants' discharge destination is collected from the participant on the day-180 telephone questionnaire, 15. Long-term outcomes post Covid-19 and ICH is collected from the participant on the day-180 telephone questionnaire, 16. Number of patients who were transferred to high dependency unit - this can be continuously monitored, throughout the duration of the trial, within the bespoke MACE-ICH database. 17. Number of patients needing high dependency or intensive care unit - this can be continuously monitored, throughout the duration of the trial, within the bespoke MACE-ICH database. 18. Number of patients undergoing neurosurgical intervention - this can be continuously monitored, throughout the duration of t | — |
Countries
United Kingdom
Contacts
Public ContactMACE-ICH trial team
Outcome results
None listed