UMC Utrecht is one of the largest public health care institutions in the Netherlands, with over 11,000 employees, including almost 1000 PhD students. The department of Neurology & Neurosurgery at UMC Utrecht treats over 600 patients with acute stroke each year. The members of the project team at UMC Utrecht have ample experience with the design, coordination, analysis, and reporting of pivotal national and international trials in the field of stroke.Including the recently completed or ongoing acute stroke trials PAIS, HAMLET, and COOLIST. The results of these trials have contributed considerably to the implementation of the following generally accepted treatments for the prevention or acute treatment of stroke:
- oral anticoagulation for atrial fibrillation (EAFT);
- aspirin and dipyridamole after cerebral ischaemia of arterial origin (ESPRIT);
- decompressive surgery for space-occupying hemispheric infarction (HAMLET).
The department of Neurology & Neurosurgery has its own clinical trial unit for the coordination of clinical trials on the prevention and treatment of stroke. The data management team of the Julius Center at UMC Utrecht supports over 50 clinical studies each year with randomisation services and/or electronic eCRFs. The department has 15 data managers, all with at least 5 years of data management experience.
Main tasks attributed in the project:
a. the design of the trial, including the writing of the study protocol;
b. the development of standard operating procedures;
c. the conduct of the trial on a day-to-day basis.
UMC Utrecht will also build and maintain a web-based randomisation platform and an eCRF to provide relevant data to WPs 3 to 7. UMC Utrecht will monitor progress of patient recruitment and intervene proactively in case of delays. UMC Utrecht will lead WP9 (project management) together with ARTTIC and contribute to WP8 (dissemination).