Pilot Study of Hypothermia for Intracerebral Hemorrhage in Croatia

Hypothermia Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01221142
• Other study ID #: HfICHiC
• Status: Not yet recruiting
• Phase: Phase 3
• First received: October 13, 2010
• Last updated: December 27, 2010
• Start date: January 2011
• Est. completion date: June 2012

Study information

• Verified date: October 2010
• Source: University of Rijeka
• Contact: Igor Antoncic, MD, MSc
• Phone: +38551658315
• Email: igor.antoncic[@]ri.t-com.hr
• Is FDA regulated: No
• Health authority: Croatia: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: June 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Hypothermia
• Primary Intracerebral Hemorrhage
• Signs and Symptoms

Intervention

Device:
• Cincinnati Sub-Zero," Blanketrol III"

Locations

Country	Name	City	State
Croatia	Intensive Care Unit, Department of Neurology, University Hospital Rijeka	Rijeka

Sponsors (2)

Lead Sponsor	Collaborator
University of Rijeka	PharmamedMado d.o.o., Zagreb, Croatia

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurological outcome		3 months after the onset	No
Primary	Neurological outcome		6 months after the onset	No
Secondary	Mortality		1 week	Yes
Secondary	Mortality		1 month	Yes
Secondary	Mortality		6 months	Yes
Secondary	The incidence of significant cardiac arrhythmias, infections, severe disturbances of electrolytes		3 days	Yes