NCT01221142

Pilot Study of Hypothermia for Intracerebral Hemorrhage in Croatia

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 20 (planned)
• Sponsor: University of Rijeka · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypothermia
• Primary Intracerebral Hemorrhage
• Signs and Symptoms

Interventions

Type	Name	Description
DEVICE	Cincinnati Sub-Zero," Blanketrol III"

Timeline

• Start date: 2011-01-01
• Primary completion: 2011-09-01
• Completion: 2012-06-01
• First posted: 2010-10-14
• Last updated: 2010-12-28

Locations

1 site across 1 country: Croatia