Pilot Study of Hypothermia for Intracerebral Hemorrhage in Croatia

Phase 3

• Conditions: Hypothermia; Primary Intracerebral Hemorrhage; Signs and Symptoms
• Interventions: Device: Cincinnati Sub-Zero," Blanketrol III"

• Registration Number: NCT01221142
• Lead Sponsor: University of Rijeka

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.

Study Timeline

• Status Verified: 2010-10
• Study First Submitted: 2010-10-13
• Study First Submitted QC: 2010-10-13
• Study First Posted: 2010-10-14
• Last Update Submitted: 2010-12-27
• Last Update Posted: 2010-12-28
• Study Start: 2011-01
• Primary Completion: 2011-09
• Study Completion: 2012-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hypothermia	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

Primary Outcome Measures

Name	Time	Method
Neurological outcome	6 months after the onset

Secondary Outcome Measures

Name	Time	Method
Mortality	6 months
The incidence of significant cardiac arrhythmias, infections, severe disturbances of electrolytes	3 days

Trial Locations

Locations (1)

Intensive Care Unit, Department of Neurology, University Hospital Rijeka; 🇭🇷 Rijeka, Croatia