Pilot Study of Hypothermia for Intracerebral Hemorrhage in Croatia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01221142|
Recruitment Status : Unknown
Verified October 2010 by University of Rijeka.
Recruitment status was: Not yet recruiting
First Posted : October 14, 2010
Last Update Posted : December 28, 2010
|Condition or disease||Intervention/treatment||Phase|
|Hypothermia Primary Intracerebral Hemorrhage Signs and Symptoms||Device: Cincinnati Sub-Zero," Blanketrol III"||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||January 2011|
|Primary Completion Date :||September 2011|
|Study Completion Date :||June 2012|
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"
- Neurological outcome [ Time Frame: 3 months after the onset ]
- Neurological outcome [ Time Frame: 6 months after the onset ]
- Mortality [ Time Frame: 1 week ]
- Mortality [ Time Frame: 1 month ]
- Mortality [ Time Frame: 6 months ]
- The incidence of significant cardiac arrhythmias, infections, severe disturbances of electrolytes [ Time Frame: 3 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|