Pilot Study of Hypothermia for Intracerebral Hemorrhage in Croatia
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Hypothermia
- Sponsor
- University of Rijeka
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Neurological outcome
- Last Updated
- 15 years ago
Overview
Brief Summary
In this pilot study the researchers will investigate efficacy of hypothermia in the early stage of treatment patients with primary intracerebral hemorrhage.
Detailed Description
The purpose of this pilot trial is to determine whether hypothermia improves neurological outcome (measured as 3 and 6 months after the onset of symptoms using mRS, GOS and BI) in patients who has suffered a primary intracerebral hemorrhage. The patients with primary intracerebral hemorrhage presented with coma (GCS ≤ 8) and ICH score 2-4 will be included. Induction of hypothermia will be initiated within 6 hours of symptoms onset. Patients will be cooled to core temperature of 34°C during 24 hours using non-invasive temperature management (Cincinnati Sub-Zero). The temperature will be measured continuously by esophageal system. After 24 hours of successful cooling, the target temperature will be gradually raised to achieve slow re-warming of 0.5°C / 2 h until the core temperature reaches 36,5°C. During hypothermia ECG, blood pressure, oxygen saturation and intracranial pressure will be measured continuously and registered every 30 min. The first CT scan of the brain, after initial, will be done early after normothermia is reached.
Investigators
Eligibility Criteria
Inclusion Criteria
- •ICH score 2-4
- •symptom onset within 6 hours
- •ages 18 - 80
Exclusion Criteria
- •pregnancy
- •hemodynamical unstability
- •recent myocardial infarction
- •systolic blood pressure \< 90 mm Hg
Outcomes
Primary Outcomes
Neurological outcome
Time Frame: 6 months after the onset
Secondary Outcomes
- Mortality(6 months)
- The incidence of significant cardiac arrhythmias, infections, severe disturbances of electrolytes(3 days)