Trial Overview Clause Samples

Trial Overview. This is a multicenter, randomized, placebo-controlled, double-blind, parallel group trial of intravenous magnesium sulfate initiated by paramedics in the field within 2 hours of symptom onset in 1298 patients with acute stroke. The primary objective of the study is to evaluate the efficacy and safety of field-initiated magnesium sulfate in improving the long-term functional outcome of patients with acute stroke. The study will be conducted employing the paramedic systems of the County of Los Angeles. These systems provide prehospital care to a population of 9.8 million. Patients with acute stroke will be identified in the field by licensed paramedics who have received training in basic and advanced cardiac life support, stroke recognition, and specific procedures relevant to the proposed study. Physician-investigators will approve each patient for study entry after cellular phone contact with paramedics. Physician-investigators will also by phone elicit consent to participate in the study, from patients when the subject is competent and from on scene or off scene legally authorized persons when the subject is not competent. Paramedics will initiate a loading dose of 4 grams magnesium sulfate iv over 16 minutes or matched placebo, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate iv over 24 hours or matched placebo. Follow-up assessments will be performed at ED arrival, 24 hours, 48 hours, day 4, day 30, and day 90. The enrollment period will last 3.5 years and the follow-up period an additional 3 months. The sites involved in the study will be all (~330) rescue engines of the Los Angeles County EMS system and all (~82) hospitals with a licensed adult patient Emergency Department in the County of Los Angeles. The Clinical Coordinating Center and the Neuroimaging Analysis Center will be at UCLA Medical Center and the Data Management Center will be coordinated through Stanford University.