Since the data available in this type of patients with this treatment is scarce and inconclusive, we will perform a randomized, triple-blind, placebo controlled trial with an interim futility analysis (interim analysis). The primary endpoint for the DEXCON TBI trial is the good recovery (GOSE 7–8) one month after the TBI.

A study with 600 patients would have about 80% power (2 sided alpha = 5%) to detect a 12% absolute increased (from 50% to 62%) in good recovery (GOSE 7–8). It includes an inflation of 10% due to non-adherence (withdrawal of consent, loss to follow-up, cross-over or change of treatment).

Note: The content above has been extracted from a research article, so it may not display correctly.



Q&A
Please log in to submit your questions online.
Your question will be posted on the Bio-101 website. We will send your questions to the authors of this protocol and Bio-protocol community members who are experienced with this method. you will be informed using the email address associated with your Bio-protocol account.



We use cookies on this site to enhance your user experience. By using our website, you are agreeing to allow the storage of cookies on your computer.