Cooling in acute Stroke-II "COAST-II"


Phase N/A Results N/A

Eligibility Criteria

Inclusion Criteria

All eligibility criteria for routine t-PA administration for acute ischemic stroke within three hours after symptom onset as outlined by the NINDS tPA Guidelines are met; patients are with any subtype of stroke are included; NIHSS must between <4 and >20.

Exclusion Criteria

Severity of stroke symptoms on the NIHSS 3 or below or 21 and above; severe aphasia which makes consent impossible; severe dysphagia, decreased level of consciousness (GCS<12); etiology other than ischemic stroke; contraindications to hypothermia, such as patients with known hematologic diseases which affect thrombosis, (cryoglobulinemia, Sickle cell disease, serum cold agglutinins), or vasospastic disorders such as Raynaud's or thromboangiitis obliterans; known co-morbid conditions likely to complicate therapy, e.g., end-stage cardiomyopathy, uncompensated arrhythmia, myopathy, liver disease severe enough to elevate bilirubin; IVC filters; dementia severe enough to prevent valid consent, end-stage AIDS, known thyroid deficiency, known renal insufficiency likely to impair pethidine clearance; pregnancy in women of child-bearing potential (must have pregnancy test, urine or blood, prior to therapy); medical conditions likely to interfere with patient assessment; known allergy to pethidine; currently taking MAO-I class of medication or used within previous 14 days; life expectancy < 6 months; not likely to be available for long-term follow-up.