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).

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