Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| PharmamedMado d.o.o., Zagreb, Croatia | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
In this pilot study the researchers will investigate efficacy of hypothermia in the early stage of treatment patients with primary intracerebral hemorrhage.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypothermia | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cincinnati Sub-Zero," Blanketrol III" | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neurological outcome | 3 months after the onset | |
| Neurological outcome | 6 months after the onset |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | 1 week | |
| Mortality | 1 month | |
| Mortality |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Igor Antoncic, MD, MSc | Contact | +38551658315 | igor.antoncic@ri.t-com.hr |
| Name | Affiliation | Role |
|---|---|---|
| Igor Antoncic, MD, MSc | Intensive Care Unit, Departmen of Neurology, University Hospital Rijeka, Croatis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intensive Care Unit, Department of Neurology, University Hospital Rijeka | Rijeka | 51000 | Croatia |
Not provided
| ID | Term |
|---|---|
| D007035 | Hypothermia |
| D012816 | Signs and Symptoms |
| D006522 | Hepatitis, Infectious Canine |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006524 | Hepatitis, Viral, Animal |
| D006520 | Hepatitis, Animal |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 6 months |
| The incidence of significant cardiac arrhythmias, infections, severe disturbances of electrolytes | 3 days |
| D007239 | Infections |
| D000257 | Adenoviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D004283 | Dog Diseases |
| D000820 | Animal Diseases |