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Pilot Study of Hypothermia for Intracerebral Hemorrhage in Croatia

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01221142
Enrollment
20
Registered
2010-10-14
Start date
2011-01-31
Completion date
2012-06-30
Last updated
2010-12-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypothermia, Primary Intracerebral Hemorrhage, Signs and Symptoms

Keywords

Hypothermia, ICH

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.

Interventions

DEVICECincinnati Sub-Zero, Blanketrol III

Sponsors

PharmamedMado d.o.o., Zagreb, Croatia
CollaboratorUNKNOWN
University of Rijeka
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Neurological outcome3 months after the onset

Secondary

MeasureTime frame
Mortality1 week
The incidence of significant cardiac arrhythmias, infections, severe disturbances of electrolytes3 days

Countries

Croatia

Contacts

Primary ContactIgor Antoncic, MD, MSc
igor.antoncic@ri.t-com.hr+38551658315

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026