Pilot Study of Hypothermia for Intracerebral Hemorrhage in Croatia

University of Rijeka

Status and phase: Unknown; Phase 3

Conditions: Signs and Symptoms; Hypothermia; Primary Intracerebral Hemorrhage

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01221142

HfICHiC

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Hypothermia

Experimental group

Description:

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

Treatment:

Device: Cincinnati Sub-Zero," Blanketrol III"