HypothermiaPhase 3NCT01221142
Pilot Study of Hypothermia for Intracerebral Hemorrhage in Croatia
A Phase 3 study testing Cincinnati Sub-Zero," Blanketrol III" in people with Hypothermia and Primary Intracerebral Hemorrhage, run by University of Rijeka at 1 site in Croatia.
Trial summary
In this pilot study the researchers will investigate efficacy of hypothermia in the early stage of treatment patients with primary intracerebral hemorrhage. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypothermia, Primary Intracerebral Hemorrhage, Signs and Symptoms
- What is being tested?
- Cincinnati Sub-Zero," Blanketrol III"
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCroatia
- Study dates
- Jan 2011to Jun 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- GCS ≤ 8
- ICH score 2-4
- symptom onset within 6 hours
- ages 18 - 80
Who cannot join
- pregnancy
- hemodynamical unstability
- recent myocardial infarction
- systolic blood pressure < 90 mm Hg
Trial locations and contacts
1 site in 1 country.
Croatia1 site
Intensive Care Unit, Department of Neurology, University Hospital Rijeka
Rijeka, 51000
Igor Antoncic, MD, MSc, +38551658315, igor.antoncic@ri.t-com.hr
Sinisa Dunatov, MD
About this study
In this pilot study the researchers will investigate efficacy of hypothermia in the early stage of treatment patients with primary intracerebral hemorrhage.
Read the 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.
- Being tested
- Cincinnati Sub-Zero," Blanketrol III"
- Keywords
- Hypothermia, ICH
- Medical subject headings
- Hypothermia, Signs and Symptoms, Hepatitis, Infectious Canine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cincinnati Sub-Zero," Blanketrol III"Device
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Cincinnati Sub-Zero," Blanketrol III" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurological outcome
Measured: 3 months after the onset
Neurological outcome
Measured: 6 months after the onset
Secondary outcomes (4)
Mortality
Measured: 1 week
Mortality
Measured: 1 month
Mortality
Measured: 6 months
The incidence of significant cardiac arrhythmias, infections, severe disturbances of electrolytes
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2010 (estimated)
- Study startJan 2011
- Primary completionSep 2011
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypothermiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- University of Rijeka
- Sponsor type
- University, hospital or other
- Collaborators
- PharmamedMado d.o.o., Zagreb, Croatia
- Investigators
- Igor Antoncic, MD, MSc, Principal investigator, Intensive Care Unit, Departmen of Neurology, University Hospital Rijeka, Croatis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01221142
- Sponsor's protocol ID
- HfICHiC
- Status last verified
- Oct 2010
- First submitted
- 13 Oct 2010
- Last updated
- 28 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Hypothermia for Intracerebral Hemorrhage in Croatia
- ClinicalTrials.gov ID
- NCT01221142
- Acronym / sponsor ID
- HfICHiC
- Keywords
- Hypothermia, ICH
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants
- Lead sponsor
- University of RijekaUniversity, hospital or other
- Collaborators
- PharmamedMado d.o.o., Zagreb, Croatia
- Study start
- Jan 2011
- Primary completion
- Sep 2011
- Study completion
- Jun 2012
- First posted
- 14 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypothermia | Experimental | Device: Cincinnati Sub-Zero," Blanketrol III"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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- GCS ≤ 8
- ICH score 2-4
- symptom onset within 6 hours
- ages 18 - 80
Key exclusion criteria (4 listed)
- pregnancy
- hemodynamical unstability
- recent myocardial infarction
- systolic blood pressure < 90 mm Hg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cincinnati Sub-Zero," Blanketrol III" | Device | Hypothermia |
Primary outcome
Neurological outcome
Time frame: 3 months after the onset
Neurological outcome
Time frame: 6 months after the onset
4 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Igor Antoncic, MD, MSc principal investigator
Intensive Care Unit, Departmen of Neurology, University Hospital Rijeka, Croatis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cincinnati Sub-Zero," Blanketrol III" in people with Hypothermia and Primary Intracerebral Hemorrhage, run by University of Rijeka at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Igor Antoncic, MD, MSc (+38551658315, igor.antoncic@ri.t-com.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurological outcome (time frame: 3 months after the onset). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2010.