Mild Hypothermia in Acute Ischemic Stroke

University of Helsinki

Status and phase

Completed

Phase 2

Conditions

Brain Ischemia

Treatments

Device: Hypothermia

Study type

Interventional

Funder types

Other

Identifiers

NCT00987922

FI-HUCH-220424

Details and patient eligibility

About

Hypothesis: Mild hypothermia using non-invasive temperature management system in a stroke unit is safe and feasible in spontaneously breathing, alteplase-thrombolyzed patients with acute ischemic stroke.

Full description

Fever is associated with higher stroke mortality and poor outcome, but it is yet unknown whether this association is causative or epiphenomenal.

In temporary brain ischemia rodent models hypothermia results in a significant increase in the number of surviving neurons and smaller infarction size as measured with histological examination after death.

Therapeutic effect has been shown in clinical trials in comatose cardiac arrest patients and newborn infants with perinatal hypoxic-ischemic brain injury.

Design: A prospective, open, randomized single-center study.

Study population: 36 patients, 18-85 years of age presenting with symptoms of acute ischemic hemispheric stroke with persisting significant neurological deficit (NIHSS 7-20 or NIHSS 2 for dysphasia or NIHSS 3 for paralysis of upper or lower limb) at 2 hours after thrombolysis.

Method: Patients are randomized to hypothermia- or control-group via randomization envelopes. Patients assigned to receive hypothermia are cooled to a core temperature of 35°C for 12 hours by means of a non-invasive temperature management system and cold i.v. fluids. Induction of hypothermia is initiated within 6 hours of symptom onset. After 12 hours of successful cooling the target temperature is gradually raised to achieve slow re-warming of 0.2°C/h until the core temperature reaches 36.8°C.

Patients are breathing spontaneously and shivering is controlled with following medication; dexmedetomidine 0.2-0.7 µg/kg/h (i.v.), buspirone 5-20 mg x 3 (nasogastric tube), and meperidine 25mg (i.v.) when needed.

Core temperature, blood pressure (BP), oxygen saturation, ECG and EEG are measured continuously and registered hourly. Blood tests will be taken before, during and after hypothermia. Brain CT will be controlled when normothermia is reached, no later than 30 hours from symptom onset. Brain MRI will be performed 3-7 days from symptom onset.

Enrollment

36 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Acute ischemic hemispheric stroke treated with Actilyse(tPA)-thrombolysis according to Meilahti protocol
NIHSS 7-20 (after thrombolysis) or a significant paresis of arm or leg (NIHSS 3, no movement against gravity) or a significant dysphasia (NIHSS 2-3) despite of the total NIHSS score
Symptom onset within 6 hour

Exclusion criteria

Platelet count < 75,000/mm3
Known coagulopathy (INR spontaneously >1.5)
Hemodynamical unstability
Recent history of angina pectoris or acute myocardial infarction
Sepsis within 72 hours
Pregnancy
Pre-existing neurological disability with modified Rankin Scale Score>2
Known allergy or intolerance to buspirone, dexmedetomidine, meperidine
Intracranial hemorrhage in brain CT scan
Intracranial mass lesion (i.e., abscess, tumor, or infection)
Participation in an other therapy trial within last 3 months
Hypothermia- treatment cannot be initiated within 6 hours of symptom onset
Protocol violation in thrombolytic therapy
Any condition where researchers assume that the patient is not suitable (must be reasoned)