Thrombolysis in Pediatric Stroke (TIPS) (NCT01591096) | Clinical Trial Compass
TerminatedPhase 1
Thrombolysis in Pediatric Stroke (TIPS)
Stopped: Lack of patient accrual
United States1 participantsStarted 2012-10
Plain-language summary
Thrombolysis in Pediatric Stroke (TIPS) is a five-year multi-center international safety and dose-finding study of intravenous (IV) tPA in children with acute ischemic stroke (AIS) to determine the maximal safe dose of intravenous Tissue Plasminogen Activator (IV-tPA) among three doses (0.75. 0.9, 1.0 mg/kg) for children age 2-17 years within 4.5 hours from onset of acute AIS.
Who can participate
Age range2 Years – 17 Years
SexALL
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Inclusion criteria
✓. Age 2 to 17 years inclusive.
✓. Clinical presentation consisting of clearly defined acute onset of neurological deficit in a pattern consistent with arterial territory ischemia.
✓. Clinically significant deficit as defined by a PedNIHSS score of ≥ 6 and ≤ 24 felt to be due to acute stroke that is not improving at the time of initiation of tPA administration
✓. 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.
✓. Radiological confirmation of an acute arterial ischemic stroke in one of two ways:
✓. Baseline neuroimaging (CT or MRI) with no evidence of intracranial hemorrhage (including HI-1, HI-2, PH-1 or PH-2). If no head CT scan is done, the pre-tPA MRI must include Gradient-recalled ECHO (GRE) imaging or Susceptibility Weighted Imaging (SWI) sequences.
✓. 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.
Exclusion criteria
✕. Patients in whom time of symptom onset is unknown.
✕. Pregnancy
✕. Clinical presentation suggestive of subarachnoid hemorrhage (SAH), even if head CT or head MRI scan is negative for blood.