Pilot Study of Hypothermia for Intracerebral Hemorrhage in Croatia

Study Overview
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Brief Summary
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In this pilot study the researchers will investigate efficacy of hypothermia in the early stage of treatment patients with primary intracerebral hemorrhage.

Detailed Description
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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.

Conditions
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Hypothermia, Primary Intracerebral Hemorrhage, Signs and Symptoms

Intervention / Treatment
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* Device: Cincinnati Sub-Zero, Blanketrol III


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: GCS ≤ 8 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypothermia<br>Device: Cincinnati Sub-Zero Hyper-Hypothermia to core temperature of 34C for 24 hours, rewarming rate 0,5/2h until the patient reaches 36,5C | Device: Cincinnati Sub-Zero, Blanketrol III<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurological outcome |  | 3 months after the onset | 
| Neurological outcome |  | 6 months after the onset | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | 1 week | 
| Mortality |  | 1 month | 
| Mortality |  | 6 months | 
| The incidence of significant cardiac arrhythmias, infections, severe disturbances of electrolytes |  | 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypothermia, ICH