IGOR SHOT ME – Investigating Global Outcomes after Radically inducing Stroke HemOrrhagic Transformation using a Magnum .44 Extracranially
Objectives – To investigate alternative treatment options for patients presenting with ischemic stroke
Design – Randomized placebo controlled trial. In the treatment group, a study assistant (Igor) will induce a hemorrhagic stroke transformation using a Magnum revolver. As the revolver will only be loaded in some cases, this will lead to a probability driven firing. With higher NIH-Stroke Scale-Scores the probability will rise. We expect the probability to be about 1 : 20, corresponding to 3-5% hemorrhagic transformation.
Participants – Patients suffering from ischemic stroke (onset 0 – 9 hours)
Main outcome measure – Our primary endpoint is the modified Rankin Scale (mRS)
Our secondary outcomes are ischemic stroke volume using MRI machines and a composite outcome of patient satisfaction, administrative costs and mortality.
Statistical analysis – For statistical analysis we will be will be using a test that yields a p<0.05 for our primary endpoint (e.g. poisson regression analysis)
We will not do any interim analysis and do not expect any mortality difference between the two groups. however, if we notice a trend towards an increase in mortality, a loss of equipoise will manifest itself and we will have to stop the study prematurely.
Expected outcomes – Due to the higher probability in treatment application in patients with higher NIH-Scores we expect a drop of the mRS from 3 in the placebo group to 2 in the treatment group.
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