The Very Old in Randomized Surgical Intracerebral Hemorrhage Trails. Limitations Induced By Upper Age Limits. - The Very Old in Randomized Surgical Intracerebral Hemorrhage Trails. Limitations Induced By Upper Age Limits. - Open Access Pub

Spontaneous intracerebral hemorrhage (ICH) is one of the leading causes of death worldwide. In randomized trials on surgical therapy inclusion of the very old was limited by the recruitment process. This study was performed to evaluate the age limits in published surgical trials on ICH, and to determine how upper age limits effect the inclusion of men and women in these and future trials on the basis of a large cohort of ICH patients in central Europe. The Hessian stroke registry, a state-wide prospective stroke databank, was used to analyze upper age limits and sex differences for patients with the diagnosis of ICH (ICD-10: I61.0 to I61.9) who were admitted between January 2010 and December 2012. Sex differences were calculated at different age cutoffs, and the proportions of potentially excluded sex-specific patients from surgical trials on ICH were calculated. Overall, 5184 patients with the diagnosis of spontaneous ICH were identified. A total of 2457 (47.4%) patients were female and 2727 (52.6%) patients were male. Mean age was 72.3 ± 13.6 years. Female patients were significantly older compared to male patients (74.9 ± 13.5 years vs. 69.9 ± 13.2 years; p<0.001). With an upper age limit of 70, 75, and 80 years, 3437 patients (66.3%), 2664 patients (51.4%), and 1765 patients (34.0%) were excluded, respectively. Upper age limits in surgical trials on ICH could lead to the exclusion of a significant portion of patients from studies. This should be noted when transferring conclusions from these trials into clinical practice. DOI10.14302/issn.2470-5020.jnrt-16-980 Spontaneous intracerebral hemorrhage (ICH) accounts for 11-22% of all strokes worldwide.1 The early case fatality rate was 25–35% in the first month. Incidence of ICH increases with advanced age.2 Over the coming decades, the aging of the population will force a major shift in clinical care of patients with ICH, and the group of patients older than 80 years will increase by the factor 2.5 from 2009 to 2050 in middle Europe.3 Differences of life expectancy between males and females lead to a higher proportion of females in the very old. This results in a higher rate of females in older patients with ICH. In stroke trials, upper age limits were used to exclude patients from these studies for different reasons.4 For older individuals, higher rates of in-hospital mortality and higher rates of moderate or severe neurological deficits were noted.5 However, the aging of the population worldwide will create a serious challenge in the treatment of ICH in the coming decades. If current treatment