[Ultra-high, short-term dexamethasone therapy in craniocerebral trauma. Rationale and design of a multicenter study]

In spite of 20 years of discussion the value of corticosteroids in the therapy of head injury still remains controversial. Most animal experiments show an improvement of edema parameters with dexamethasone given immediately after trauma; pharmacological data suggest a further increased "ultrahigh" dosage compared to so-called "high" doses up to now. Simultaneously, the treatment duration might be reduced to 48-72 h after injury. The clinical studies available are not satisfying due to low numbers of patients, insufficient trauma classification and restriction to most severe brain injuries, and do not allow a definite answer. Little side effects and risks, however, were found with clinical steroid trials so far. We therefore perform a new multicenter trial with dexamethasone after head injury, whose design is presented: A sufficient number of patients (n greater than = 240) is recruited according to a priori defined criteria for statistical evaluation. Treatment starts with ultrahigh dosage of 500 mg dexamethasone (Fortecortin) initially not later than 3 h after injury, the treatment duration is limited to 51 h. The selection of patients is based on restrictive criteria of inclusion and exclusion, the age of patients ranges from 15 to 55 years. For maximal statistical separation and for reduction of disturbing factors the representativity of trauma patients is intentionally neglected.