WP01 - Set-up framework

WAKE-UP will integrate outstanding scientific and clinical expertise from the consortium members applying a novel MRI approach in a large randomised controlled clinical trial of thrombolysis in patients with wake-up stroke. This WP will set up the framework for the successful conduction of the clinical trial at the highest scientific and clinical level. The objectives of this WP are: 

  • To ensure the highest scientific and clinical quality level of the clinical trial and the overall project
  • To make sure that the trial will comply at best with patients’ needs and stakeholders interests expressed in the call
  • To set the ground for an effective and successful conduction of the clinical trial within the given time period and with the resources available

All scientific partners will be involved in this WP bringing in their expertise in acute stroke imaging and clinical stroke trials. The participation of participant 08 (the Stroke Alliance for Europe, SAFE) will also ensure that the trial will comply with patients’ needs and stakeholders interests.

In this WP clinical trial protocol and data management structures will be finalised and the necessary trial boards will be set up. The infrastructure for central image data handling will be constituted. A network of clinical trial centres will be constituted. The infrastructure for supply with the study medication will be set up. Finally, overall performance of the clinical trial will be monitored and, if necessary, a contingency plan will be deployed.

This WP will be led by participant 01 (G. Thomalla, UKE). The WP will be active during months 01-36.

Participants involved in WP01: