This project includes all aspects of data coordination and management, for studies of interventional therapies for stroke initiated by task orders issued under the aegis of the STP Master Agreement. Currently six studies, each with two clinical centers, are in various stages of operation. A dose escalation study of Naloxone on 27 patients with acute cerebral ischemia has been completed and based on maximum tolerated dose, toxicity, and adverse effects were established. A Phase II study of Naloxone with 38 patients was undertaken and analysis files have been constructed. A pilot study of the benefits of hypervolemic hemodilution (DEXTRAN-40) for the treatment of stroke-in-evolution, and a dose-escalation Phase II study of Nicardipine, a calcium channel blocker, for the prevention of vasospasm following subarachnoid hemorrhage are ongoing. Data management systems have been created for Phase II studies of Heparinoid and Nicardipine for the treatment of acute cerebral ischemia. Patient accrual and data collection for the first study began in May and the other begins in July, 1986. They both will continue patient accrual for approximately one year.
