Thrombolysis in Pediatric Stroke (TIPS)
This is an unblinded study. The child will have to meet all of the inclusion and exclusion criteria within a 4.5 hour time frame. There are two dosage cohort groups 2-10 and 11-17 years of age. The Bayesian method of toxicity probability intervals will be used to select one of the following three dose tiers 0.75. 0.9, 1.0 mg/kg for iV tPa. The dose ecalation for each group will be independant of each other. a head CT will be completed to assess for intracranial hemorrhage at roughly the 24 hour post infusion.Toxicity for each child will be measured at the 36 hour post infusion timepoint. an acute neurological examination to assess outcomes at 2, 12, 24, 36, 48 hours post tPa. The neurological examination again 7 days post infusion if still hospitalized. The 3 month post transfusion will have more extensive outcomes questionnaires and examinations. The study endpoint is 3 months post tPa infusion.
1. Age 2 to 17 years inclusive.
2. Clinical presentation consisting of clearly defined acute onset of neurological deficit in a pattern consistent with arterial territory ischemia.
3. Clinically significant deficit as defined by a PedNIHSS score of >= 4 felt to be due to acute stroke that is not improving at the time of initiation of tPA administration
4. Time of symptom onset within 4.5 hours of initiation of treatment for IV tPA. Time of symptom onset is defined as time the patient was last seen awake and at neurological baseline.
5. Radiological confirmation of an acute arterial ischemic stroke in one of two ways:
a. MRI confirmation, consisting of acute infarction with restricted diffusion in an arterial territory consistent with the clinical syndrome plus MRA showing partial or complete occlusion in an intracranial artery corresponding to the infarct location, OR
b. CT and CT angiogram confirmation, consisting of normal head CT or early hypodensity in an arterial territory consistent with the clinical syndrome plus CT angiogram showing partial or complete occlusion in an intracranial artery corresponding to the infarct location.
6. Baseline neuroimaging (CT or MRI) with no evidence of intracranial hemorrhage. If no head CT scan done, pre-tPA MRI must include GRE or susceptibility weighted imaging (SWI) sequences.
7. Children with seizures at or following onset of stroke may be included, as long as the clinical picture is consistent with the documented arterial occlusion.
NIHSS is an abbreviation for NIH stroke scale examination. Only a Neurologist may give this examination. It is a stroke diagnostic specific examination. This examination is the national standard for stroke care and the physician must show documentation of proficiency in NIHSS standards.