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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. 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
PharmamedMado d.o.o., Zagreb, Croatia
Information provided by:
University of Rijeka

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2011
Primary Completion Date : September 2011
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Hypothermia

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"

Primary Outcome Measures :
  1. Neurological outcome [ Time Frame: 3 months after the onset ]
  2. Neurological outcome [ Time Frame: 6 months after the onset ]

Secondary Outcome Measures :
  1. Mortality [ Time Frame: 1 week ]
  2. Mortality [ Time Frame: 1 month ]
  3. Mortality [ Time Frame: 6 months ]
  4. The incidence of significant cardiac arrhythmias, infections, severe disturbances of electrolytes [ Time Frame: 3 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01221142

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Contact: Igor Antoncic, MD, MSc +38551658315

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Intensive Care Unit, Department of Neurology, University Hospital Rijeka
Rijeka, Croatia, 51000
Contact: Igor Antoncic, MD, MSc    +38551658315   
Sub-Investigator: Sinisa Dunatov, MD         
Sub-Investigator: Marina Bralic, MD, MSc         
Sponsors and Collaborators
University of Rijeka
PharmamedMado d.o.o., Zagreb, Croatia
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Principal Investigator: Igor Antoncic, MD, MSc Intensive Care Unit, Departmen of Neurology, University Hospital Rijeka, Croatis
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Responsible Party: University Hospital Rijeka, Igor Antončić MD Identifier: NCT01221142    
Other Study ID Numbers: HfICHiC
First Posted: October 14, 2010    Key Record Dates
Last Update Posted: December 28, 2010
Last Verified: October 2010
Keywords provided by University of Rijeka:
Hypothermia, ICH
Additional relevant MeSH terms:
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Cerebral Hemorrhage
Pathologic Processes
Body Temperature Changes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases