This project includes all statistical aspects of design, planning, data coordination and management, and analysis for studies of interventional therapies initiated by task orders issued under the aegis of the STP Master Agreement. Currently three studies, each with two clinical centers, are in various stages of operation. A pilot study of treatment of acute cerebral ischemia with large doses of Naloxone, 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. A dose-escalation study of Naloxone was completed prior to the initiation of the pilot study. No major dose-related side effects occurred and a maximal reasonably tolerated dose was determined to be 160 mg/m2 loading with total dose after infusion of 4 g/m2. Two additional studies of stroke treatment will be initiated in FY'86 under the Master Agreement and BFSB will have responsibility for the statistical aspects of these projects.
