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Pilot Study of Hypothermia for Intracerebral Hemorrhage in Croatia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by University of Rijeka.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
PharmamedMado d.o.o., Zagreb, Croatia
Information provided by:
University of Rijeka
ClinicalTrials.gov Identifier:
NCT01221142
First received: October 13, 2010
Last updated: December 27, 2010
Last verified: October 2010
History of Changes
  Purpose

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


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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Hypothermia
U.S. FDA Resources

Further study details as provided by University of Rijeka:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 20
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)
Arms Assigned Interventions
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"

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01221142

Contacts
Contact: Igor Antoncic, MD, MSc +38551658315 igor.antoncic@ri.t-com.hr

Locations
Croatia
Intensive Care Unit, Department of Neurology, University Hospital Rijeka Not yet recruiting
Rijeka, Croatia, 51000
Contact: Igor Antoncic, MD, MSc     +38551658315     igor.antoncic@ri.t-com.hr    
Sub-Investigator: Sinisa Dunatov, MD            
Sub-Investigator: Marina Bralic, MD, MSc            
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
  More Information

No publications provided

Responsible Party: University Hospital Rijeka, Igor Antončić MD
ClinicalTrials.gov Identifier: NCT01221142     History of Changes
Other Study ID Numbers: HfICHiC
Study First Received: October 13, 2010
Last Updated: December 27, 2010
Health Authority: Croatia: Ethics Committee

Keywords provided by University of Rijeka:
Hypothermia, ICH

Additional relevant MeSH terms:
Hemorrhage
Hypothermia
Signs and Symptoms
Cerebral Hemorrhage
Pathologic Processes
Body Temperature Changes
Intracranial Hemorrhages
 Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013