Diffusion-weighted Imaging Evaluation For Understanding Stroke Evolution "DEFUSE"

Recruiting

Phase N/A Results

Eligibility Criteria

Inclusion Criteria

Patients with a clinical diagnosis of ischemic stroke with an NIHSSS > 5, who could be treated with IV tPA injection within 3 to 6 hours after symptom onset.

Exclusion Criteria

Stroke within the previous 6 weeks, seizure <6 hours prior to administration of study drug, coma or severe obtundation with fixed eye deviation and complete hemiplegia, NIHSS <6 or rapidly improving major symptoms, preexisting Modified Rankin Scale Score of 3 or higher, history of ICH, SAH, AVM, aneurysm, or previously known intracranial neoplasm that, in the opinion of the investigator, is terminal, or would increase the risk of intracranial bleeding after administration of thrombolytic therapy, or may confound neurological assessment, clinical presentation suggestive of subarachnoid hemorrhage, even if initial CT is normal, hypertension: SBP > 185 mmHg; or DBP > 110 mmHg on repeated measures prior to study entry requiring aggressive treatment to reduce blood pressure to within these limits, presumed septic embolus, AMI <30 days, biopsy <30 days of a parenchymal organ or surgery that would increase the risk of unmanageable (e.g., uncontrolled by local pressure) bleeding after administration of thrombolytic therapy, trauma <30 days, with internal injuries or ulcerative wounds, any active or recent (within 30 days) hemorrhage that, in the opinion of the investigator, would increase the risk of unmanageable (e.g., uncontrolled by local pressure) bleeding after administration of thrombolytic therapy,known hereditary or acquired hemorrhagic diathesis, glucose < 50 or > 400 mg/dL, platelets <100,000/mm3, Hct < 25, other serious, advanced, or terminal illness.