Integration and validation

 

This WP will integrate the virtual population models from WP2 with the thrombolysis modelling from WP3, the thrombectomy modelling from WP4, and the perfusion and brain tissue damage modelling from WP5 into the INSIST in silico clinical trials for acute ischemic stroke. To achieve this goal, we will set up a suitable computing environment that seamlessly carries out in silico clinical trials. We will perform, in close collaboration with WP2-WP5, a formal Verification, Validation, and Uncertainty Quantification of the fully integrated in silico clinical trial, and finally run three in silico clinical trials, addressing the three R&D questions described below;

 

Trial initiator

Hypothesis

Study design

Medical device industry

Finer smaller grained configurations of stent-retrievers reduce thrombus fragmentation and thus result in an improvement of treatment of patients with acute ischemic stroke

In silico randomized clinical trial

Pharma industry

Does the reduction of active Thrombin-Activatable Fibrinolysis Inhibitor (TAFIa) improve recanalization of tissue plasminogen activator or improve microvascular reperfusion after thrombectomy?

In silico randomized clinical trial

Treating health professionals

Patients with a high-risk of large vessel occlusion stroke benefit from an early start of thrombectomy before the administration of thrombolysis.

In silico randomized clinical trial

 Description of three clinically relevant hypotheses to be addressed by in silico clinical trials

 

Objectives:

1. Integrate the in silico models into an in silico clinical trial for acute ischemic stroke.

2. Validate using formal VVUQ procedures;

3. Apply the resulting in silico clinical trial to three relevant R&D questions.