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Pilot Study of Hypothermia for Intracerebral Hemorrhage in Croatia

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

Tracking Information
First Submitted Date  ICMJE October 13, 2010
First Posted Date  ICMJE October 14, 2010
Last Update Posted Date December 28, 2010
Study Start Date  ICMJE January 2011
Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 21, 2010)
  • Neurological outcome [ Time Frame: 3 months after the onset ]
  • Neurological outcome [ Time Frame: 6 months after the onset ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 13, 2010)
Pilot Study og Hypothermia for Intracerebral Hemorrhage in Croatia
Neurological outcome (Time Frame: 3 and 6 mounths after the onset)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 21, 2010)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 13, 2010)
Pilot Study og Hypothermia for Intracerebral Hemorrhage in Coatis
Mortality after one week, one mount and during follow-up (Designated as safety issue: Yes) The incidence of significant cardiac arrhythmias, hemodynamical disturbance, infections, severe disturbance of electrolites and fluid balance (Designated as safety issue: Yes)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot Study of Hypothermia for Intracerebral Hemorrhage in Croatia
Official Title  ICMJE Not Provided
Brief Summary In this pilot study the researchers will investigate efficacy of hypothermia in the early stage of treatment patients with primary intracerebral hemorrhage.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypothermia
  • Primary Intracerebral Hemorrhage
  • Signs and Symptoms
Intervention  ICMJE Device: Cincinnati Sub-Zero," Blanketrol III"
Study Arms  ICMJE 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
Intervention: Device: Cincinnati Sub-Zero," Blanketrol III"
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: October 13, 2010)
20
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE June 2012
Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Croatia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01221142
Other Study ID Numbers  ICMJE HfICHiC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital Rijeka, Igor Antončić MD
Study Sponsor  ICMJE University of Rijeka
Collaborators  ICMJE PharmamedMado d.o.o., Zagreb, Croatia
Investigators  ICMJE
Principal Investigator: Igor Antoncic, MD, MSc Intensive Care Unit, Departmen of Neurology, University Hospital Rijeka, Croatis
PRS Account University of Rijeka
Verification Date October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP