Acute spontaneous intracerebral haemorrhage
Conditions
Interventions
Study Settings include the following:
• National Hospital of Sri Lanka
• Colombo South Teaching Hospital
• Kurunegala Teaching Hospital
• Karapitiya Teaching Hospital
• Jaffna Teaching Hospital
• K
randomly assigned by a statistician. Participating sites will be stratified according to country and size of site. When the site is ready, they will be notified of the randomised group within 2 weeks
in the case of significant abnormalities, they were taken daily.
Goal-directed care bundle of active management group will include
1. Early intensive BP lowering. The aim is to achieve a systolic BP level 55 bpm, repeat labetalol 10 mg bolus in 5 minutes. labetalol 20 mg IV push q 5 mins until target SBP reached (< 140mmHg) or H
increase to 40 mg bolus if required. Maximum labetalol dose: 300 mg / 24 hours
2. Intensive glucose control. The aim is to achieve a target blood glucose level of 6.1-7.8 mmol/l for non-diabetic pati
Sponsors
The George Institute for Global Health (Australia) Beijing Representative Office
Eligibility
Inclusion criteria
Inclusion criteria: • Age >= 18 (both male and female) • Acute stroke syndrome that is due to presumed spontaneous ICH, confirmed by clinical history and a CT scan within 6 hours of stroke onset without/without contrast, and if an CT angiogram is also undertaken as part of routine care. • Presentation to hospital within 6 hours of stroke onset
Exclusion criteria
Exclusion criteria: • Definite evidence that the ICH is secondary to a structural abnormality in the brain (eg an AVM, intracranial aneurysm, tumour, trauma, or previous cerebral infarction) or previous thrombolysis. • A high likelihood that the patient will not adhere to the study treatment and follow-up regimen. In each case, the decision about the patient’s eligibility will be based on the attending clinician’s interpretation of the above eligibility criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional recovery according to an ordinal shift analysis of the full range of scores on the modified Rankin scale (mRS) scores at 6 months [6 Months ] | — |
Secondary
| Measure | Time frame |
|---|---|
| Functional recovery according to a shift analysis of scores on the National Institutes of Health Stroke Scale (NIHSS) at 7 days. The following at 6-months: poor outcome defined by mRS scores of 3-6; separately on death and disability (mRS 3-5); health-related quality of life (HRQoL) using the EuroQoL Group 5-Dimension self-report questionnaire (EQ-5D); duration of hospitalisation; and residence. [6 months] | — |
Countries
Sri Lanka
Contacts
Public ContactDr.Bimsara Senanayake
Consultant Neurologist
Outcome results
None listed