Randomization If a patient is eligible for the trial the diagnostic imaging pathway for initial assessment in the trauma resuscitation room will be determined by randomization. The randomization will be performed immediately after inclusion at computers selleck Temsirolimus located in the trauma room of the participating hospitals. Randomization will be performed using a ‘one-click’ computer

program on a 1:1 basis per hospital with varying block sizes of 2, 4, 6, 8, 10 and 12. The Inhibitors,research,lifescience,medical trauma team will be directly informed on the outcome of the randomization so that imaging can be started. A standardized case record from (CRF) will be used. This CRF is totally web-based via a secured internet module. Sample size animal study calculation and data analysis A previous study reported a reduction in mortality from 15% to 8.6% with Inhibitors,research,lifescience,medical total-body CT scanning as the single diagnostic procedure during trauma evaluation as compared to historical control data [29].

Analysis on the large German polytrauma registration database performed by Huber-Wagner et al. showed a significant reduction in Inhibitors,research,lifescience,medical the 24-h mortality in patient who underwent immediate total-body CT compared to the conventional group (10% vs. 12%, P = 0.038) [25]. Historical AMC data show a mortality rate of 12% for trauma patients matching the current trial inclusion criteria. Inhibitors,research,lifescience,medical Based on the combination

of the AMC data and the participation of the other trauma centers with comparable trauma populations, it is expected to find a reduction in mortality from 12% to 7%. The detection of such a difference requires 539 patients per group using a power of 80% and a two-sided alpha of 5%. Based on the historical and estimated data of the participating centers the inclusion period will take about 1,5 years and the follow-up period will take an additional year. The main analyses of primary and secondary outcomes will be conducted for all randomized patients according to the result of the randomization (intention-to-treat). Inhibitors,research,lifescience,medical Data are expressed as percentages for categorical data, as mean and standard deviation (SD) for normally distributed numerical data and as median, range, and, where appropriate, inter-quartile range (IQR Brefeldin_A = 25 to 75%) for non-normally distributed numerical data. The following subgroups will be used for subgroup analysis: – multitrauma patients (defined as Injury Severity Score (ISS) >/=16); – severe traumatic brain injury patients (defined as admission Glasgow Coma; Scale (GCS) ≤ 8 and an Abbreviated Injury Score (AIS)-head of ≥ 3); – penetrating versus blunt trauma. A p-value less than 0.05 is considered statistically significant. If appropriate, predictive values between variables are calculated.