Pilot Study of Hypothermia for Intracerebral Hemorrhage in Croatia
Recruitment status was Not yet recruiting
In this pilot study the researchers will investigate efficacy of hypothermia in the early stage of treatment patients with primary intracerebral hemorrhage.
Primary Intracerebral Hemorrhage
Signs and Symptoms
Device: Cincinnati Sub-Zero," Blanketrol III"
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
- Neurological outcome [ Time Frame: 3 months after the onset ] [ Designated as safety issue: No ]
- Neurological outcome [ Time Frame: 6 months after the onset ] [ Designated as safety issue: No ]
- Mortality [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
- Mortality [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
- Mortality [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- The incidence of significant cardiac arrhythmias, infections, severe disturbances of electrolytes [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||June 2012|
|Estimated Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
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"|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01221142
|Contact: Igor Antoncic, MD, MScemail@example.com|
|Intensive Care Unit, Department of Neurology, University Hospital Rijeka||Not yet recruiting|
|Rijeka, Croatia, 51000|
|Contact: Igor Antoncic, MD, MSc +38551658315 firstname.lastname@example.org|
|Sub-Investigator: Sinisa Dunatov, MD|
|Sub-Investigator: Marina Bralic, MD, MSc|
|Principal Investigator:||Igor Antoncic, MD, MSc||Intensive Care Unit, Departmen of Neurology, University Hospital Rijeka, Croatis|