Pilot Study of Hypothermia for Intracerebral Hemorrhage in Croatia

December 27, 2010 updated by: University of Rijeka
In this pilot study the researchers will investigate efficacy of hypothermia in the early stage of treatment patients with primary intracerebral hemorrhage.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment

20

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Rijeka, Croatia, 51000
        • Intensive Care Unit, Department of Neurology, University Hospital Rijeka

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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"

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Neurological outcome
Time Frame: 3 months after the onset
3 months after the onset
Neurological outcome
Time Frame: 6 months after the onset
6 months after the onset

Secondary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: 6 months
6 months
Mortality
Time Frame: 1 month
1 month
Mortality
Time Frame: 1 week
1 week
The incidence of significant cardiac arrhythmias, infections, severe disturbances of electrolytes
Time Frame: 3 days
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rijeka

Collaborators

PharmamedMado d.o.o., Zagreb, Croatia

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion

September 1, 2011

Study Completion

June 1, 2012

Study Registration Dates

First Submitted

October 13, 2010

First Submitted That Met QC Criteria

October 13, 2010

First Posted (ESTIMATE)

October 14, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

December 28, 2010

Last Update Submitted That Met QC Criteria

December 27, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HfICHiC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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