IMPACT Background

TBI is a dynamic and heterogeneous disease in which many mechanisms and pathways can lead to secondary damage. Many different kinds of therapy and neuroprotective agents with high potential for efficacy have been developed.

Unfortunately in trials none of these have shown convincing evidence of benefit in the clinical situation with sufficient generalizibility. Some of these therapies may have been truly ineffective but the risk exists that some therapies may have been wrongly discarded due to the use of insensitive methodology in clinical trials.

The TBI population poses several complicated methodological challenges, related to the heterogeneity of the population, outcome-assessment and design issues. IMPACT is focused on tackling these head-on with the aim of providing recommendations for more powerful trials in the future.