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Pilot Study of Hypothermia for Intracerebral Hemorrhage in Croatia

NCT ID: NCT01221142

Last Updated: 2010-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Hypothermia Primary Intracerebral Hemorrhage Signs and Symptoms

Keywords

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Hypothermia, ICH

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Cincinnati Sub-Zero," Blanketrol III"

Intervention Type DEVICE

Interventions

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Cincinnati Sub-Zero," Blanketrol III"

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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PharmamedMado d.o.o., Zagreb, Croatia

UNKNOWN

Sponsor Role collaborator

University of Rijeka

OTHER

Sponsor Role lead

Principal Investigators

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Igor Antoncic, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Intensive Care Unit, Departmen of Neurology, University Hospital Rijeka, Croatis

Locations

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Intensive Care Unit, Department of Neurology, University Hospital Rijeka

Rijeka, , Croatia

Site Status

Countries

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Croatia

Central Contacts

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Igor Antoncic, MD, MSc

Role: CONTACT

Phone: +38551658315

Email: [email protected]

Facility Contacts

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Igor Antoncic, MD, MSc

Role: primary

Other Identifiers

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HfICHiC

Identifier Type: -

Identifier Source: org_study_id