In this context, the prospective European study conducted to assess the impact of vasopressin infusion as a salvage therapy in prehospital hemorrhagic shock that persists despite standard treatment, including a first line vasopressor (Vasopressin In Traumatic Shock (VITRIS) trial, NCT00379522), may provide an answer.
We propose that NMDA receptor antagonists failed stroke and traumatic brain injury trials in human beings because blockade of synaptic transmission mediated by NMDA receptors hinders neuronal survival.
Instead, with perverse glee, he praised "the sulphurous anger of Dante, the self-disgust of Baudelaire, and the blasphemies of Villon", noting with approval that their fates involved traumatic exile, an obscenity trial and the threat of hanging.
But starting next month, it will be the focus of a phase III clinical trial for traumatic brain injury (TBI).
An ongoing National Institutes of Health-sponsored phase II clinical trial in traumatic brain injury patients uses a PbtO2 threshold of 20 mmHg to initiate therapy [ 26].
Clinical trials in traumatic brain injury (TBI) pose complex methodological challenges, largely related to the heterogeneity of the population.
In this article, we review past and current experience in clinical trials of traumatic brain injuries (TBIs), we discuss limitations and challenges, and we summarize current directions.
To date, despite very encouraging preclinical results, almost all phase II/III clinical neuroprotection trials in traumatic brain injury (TBI) have failed to show any consistent improvement in outcome for TBI patients.
Potential explanations for the many failed clinical trials in traumatic brain injury (TBI) include, but are not limited to, heterogeneity of the patient population, site-to-site variability in patient care, sensitivity of the selected endpoint, and inadequacy of the trial design.
SMM is an investigator in the Traumatic Brain Injury Clinical Trials Network.
