Applicability of Clinical Trials in an Unselected Cohort of Patients With Intracerebral Hemorrhage
Background and Purpose—Patient selection in clinical trials on intracerebral hemorrhage (ICH) affects overall applicability of results. We estimated eligibility for completed, ongoing, and planned clinical trials in an unselected cohort of patients with ICH.
Methods—Large clinical ICH trials were identified using trial registration databases. Each trial’s inclusion criteria were applied to a consecutive group of patients with ICH from the prospective hospital-based Lund Stroke Register. Survival status was obtained from the National Census Office and 90-day poor functional outcome (modified Rankin Scale ≥4) from the Swedish Stroke Register or medical files.
Results—Among 253 patients with ICH, estimated eligibility proportions ranged between 2% and 36% for the 11 identified clinical trials. Patients not eligible for any trial (n=96) had more intraventricular hemorrhage, lower baseline level of consciousness, higher rates of cerebellar ICH, and lower rates of lobar ICH (P≤0.001). Thirty-day case fatality for noneligible patients was 54% versus 18% among patients eligible in ≥1 trial (95% confidence interval, 44%–64% versus 13%–25%; P<0.001). Noneligible ICH patients more frequently had poor functional outcome (75% versus 48%; 95% confidence interval, 65%–83% versus 40%–56%; P<0.001).
Conclusions—There is large variation in proportions of patients with ICH eligible for inclusion in clinical trials and over a third of patients with ICH are not eligible for any trial.
- Received June 21, 2016.
- Revision received August 1, 2016.
- Accepted August 9, 2016.
- © 2016 American Heart Association, Inc.