Health Condition 1: null- Intracerebral Haemorrhage Stroke Hypertension Health Condition 2: G998- Other specified disorders of nervous system in diseases classified elsewhere
Conditions
Interventions
Intervention1: Intensive Blood pressure reduction: Intensive arm: Intensive Blood pressure (BP) lowering therapy is given via an intravenous drip for 24 hours. The target is to reach a systolic BP <
140mmHg within 1 hour.
Control Intervention1: Conservative Management of Blood Pressure: Conservative arm: Patients will receive management of BP that is based on a standard guideline, as published by
Sponsors
The National Health and Medical Research Council NHMRC of Australia
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patient older than 18 years old (there is no upper age limit). 2.Acute stroke syndrome due to spontaneous ICH, confirmed by clinical history and CT scan 3.At least two systolic BP measurements of more than or equal to 150 mmHg and less than or equal to 220 mmHg, recorded 2 or more minutes apart. 4.Able to commence randomly assigned BP lowering regimen within 6 hours of stroke onset. 5.Able to be â??activelyâ?? treated and admitted to a monitored facility
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1.Clear indication or contraindication to intensive BP lowering. 2.Evidence ICH secondary to a structural abnormality 3.Recent (within 1 month) use of a thrombolytic agent 4.Previous ischaemic stroke within 30 days 5.A very high likelihood that the patient will die within the next 24 hours on the basis of clinical and/or radiological criteria 6.Score of 3-5 on the Glasgow Coma Scale (indicating deep coma) 7.Significant pre-stroke disability or advanced dementia 8.Planned early neurological intervention 9.Participation in another clinical trial. 10.A high likelihood that the patient will not adhere to the study treatment and follow-up regimen.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measure: A composite of death or dependency, with dependency being defined by a score of 3 to 5 on the modified Rankin Scale (mRS) Timepoint: Time Frame: 90 days | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the effect of the treatment on the primary outcome in a subgroup of patients who receive treatment within 4 hours of ICH onset. Other secondary outcomes 1.Mortality, Dependency(measured by mRS)& HRQoL (measured by the EuroQuol5D) at Day 28&90 4.Recurrent stroke 5.Acute myocardial infarction (or sudden death) from a cardiovascular cause 6.Need for permanent residential care 7.Duration of initial hospital stayTimepoint: 1.Mortality at 28 days and 90 days 2.Dependency (measured by mRS) at 28 days and 90 days 3.HRQoL (measured by the EuroQuol 5D) at 28 days and 90 days. 4.Recurrent stroke after 24 hours of the initial ICH. 5.Acute myocardial infarction (or sudden death) from a cardiovascular cause, according to standard definitions. 6.Need for permanent residential care 7.Duration of initial hospital stay | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Chile, China, Finland, France, Germany, Hong Kong, India, Italy, Netherlands, Norway, Pakistan, Portugal, Spain, Switzerland, United Kingdom, United States of America
Contacts
Public ContactKMallikarjuna
National Coordinator
Outcome results
None listed