Characteristics of traumatic intracerebral haemorrhage: An assessment of screening logs from the STITCH(Trauma) Trial.

INTRODUCTION

In undertaking international neurosurgical trials it is useful to understand international patient demographics and potential patient populations that study results will apply to. The STITCH(Trauma) trial included 59 centres from 20 countries, which were requested to screen all patients with traumatic intracerebral haemorrhage. This paper reviews these data.

MATERIALS AND METHODS

Demographic, clinical and exclusion reason data were analysed. Comparisons were made between patients who were included in the trial and patients who were potentially eligible (but not included in the trial) and patients who were not potentially eligible.

RESULTS

Screening evidence was returned for 1735 patients, 11% of these may potentially have been eligible, of whom 52% were not included because consent could not be gained. By country, median age per centre ranged from 26 years (Egypt) to 67 years (Germany), median time from injury to screening ranged from 5 h (Germany and Nepal) to 16 h (India), median intracerebral haemorrhage (ICH) volume ranged from 5 ml (Germany) to 30 ml (China), the proportion of male patients ranged from 56% (Egypt) to 91% (Canada) and the proportion of patients with both pupils reactive ranged from 68% (China) to 98% (Nepal). The most common exclusion reasons were ICH volume < 10 ml (49%) and presence of subdural haemorrhage/extradural haemorrhage or SDH/EDH requiring surgery (20%).

CONCLUSION

Data presented here including international patient demographics and reasons for patient ineligibility will be useful for future traumatic ICH studies.