NCT01221142

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 14, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

December 28, 2010

Status Verified

October 1, 2010

Enrollment Period

8 months

First QC Date

October 13, 2010

Last Update Submit

December 27, 2010

Conditions

HypothermiaPrimary Intracerebral HemorrhageSigns and Symptoms

Keywords

Hypothermia, ICH

Outcome Measures

Primary Outcomes (2)

  • Neurological outcome

    3 months after the onset

  • Neurological outcome

    6 months after the onset

Secondary Outcomes (4)

  • Mortality

    1 week

  • Mortality

    1 month

  • Mortality

    6 months

  • The incidence of significant cardiac arrhythmias, infections, severe disturbances of electrolytes

    3 days

Study Arms (1)

Hypothermia

EXPERIMENTAL

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"

Interventions

Cincinnati Sub-Zero," Blanketrol III"DEVICE
Hypothermia

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • GCS ≤ 8
  • ICH score 2-4
  • symptom onset within 6 hours
  • ages 18 - 80

You may not qualify if:

  • pregnancy
  • hemodynamical unstability
  • recent myocardial infarction
  • systolic blood pressure \< 90 mm Hg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intensive Care Unit, Department of Neurology, University Hospital Rijeka

Rijeka, 51000, Croatia

Location

MeSH Terms

Conditions

HypothermiaSigns and SymptomsHepatitis, Infectious Canine

Condition Hierarchy (Ancestors)

Body Temperature ChangesPathological Conditions, Signs and SymptomsHepatitis, Viral, AnimalHepatitis, AnimalInfectionsAdenoviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitisLiver DiseasesDigestive System DiseasesDog DiseasesAnimal Diseases

Study Officials

  • Igor Antoncic, MD, MSc

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Igor Antoncic, MD, MSc

CONTACT

+38551658315igor.antoncic@ri.t-com.hr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 13, 2010

First Posted

October 14, 2010

Study Start

January 1, 2011

Primary Completion

September 1, 2011

Study Completion

June 1, 2012

Last Updated

December 28, 2010

Record last verified: 2010-10

Locations

CR(1)