Pilot Study of Hypothermia for Intracerebral Hemorrhage in Croatia

• Sponsor: University of Rijeka (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01221142
• Collaborator: PharmamedMado d.o.o., Zagreb, Croatia (Other)
• Enrollment: 20
• Location: 1
• Arm: 1
• Duration (Months): 17
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hypothermia; Primary Intracerebral Hemorrhage; Signs and Symptoms	Device: Cincinnati Sub-Zero," Blanketrol III"	Phase 3

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.

Study Design

• Study Type: Interventional
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Jan 1, 2011
• Primary Completion Date: Sep 1, 2011
• Study Completion Date: Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hypothermia 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"

Outcome Measures

Primary Outcome Measures

1. Neurological outcome [3 months after the onset]

2. Neurological outcome [6 months after the onset]

Secondary Outcome Measures

1. Mortality [1 week]

2. Mortality [1 month]

3. Mortality [6 months]

4. The incidence of significant cardiac arrhythmias, infections, severe disturbances of electrolytes [3 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Intensive Care Unit, Department of Neurology, University Hospital Rijeka	Rijeka		Croatia	51000

Sponsors and Collaborators

• University of Rijeka
• PharmamedMado d.o.o., Zagreb, Croatia

Investigators

• Principal Investigator: Igor Antoncic, MD, MSc, Intensive Care Unit, Departmen of Neurology, University Hospital Rijeka, Croatis

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01221142
• Other Study ID Numbers: HfICHiC
• First Posted: Oct 14, 2010
• Last Update Posted: Dec 28, 2010
• Last Verified: Oct 1, 2010

• Keywords provided by , ,: Hypothermia, ICH
• Additional relevant MeSH terms: Cerebral Hemorrhage; Hemorrhage; Hypothermia

Study Results

No Results Posted as of Dec 28, 2010