Applicability of Clinical Trials in an Unselected Cohort of Patients With Intracerebral Hemorrhage.
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.



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.



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).



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.
From the Department of Clinical Sciences, Neurology, Lund University, Sweden (B.M.H., B.N., A.L.); Department of Neurology and Rehabilitation Medicine, Skåne University Hospital, Lund, Sweden (B.M.H., B.N., A.L.); and Division of Brain Injury Outcomes, Johns Hopkins Medical Institutions, Baltimore, MD (N.U., D.F.H.). Bjorn.Hansen@med.lu.se.
Björn M
BM
Hansen
From the Department of Clinical Sciences, Neurology, Lund University, Sweden (B.M.H., B.N., A.L.); Department of Neurology and Rehabilitation Medicine, Skåne University Hospital, Lund, Sweden (B.M.H., B.N., A.L.); and Division of Brain Injury Outcomes, Johns Hopkins Medical Institutions, Baltimore, MD (N.U., D.F.H.).
Natalie
N
Ullman
From the Department of Clinical Sciences, Neurology, Lund University, Sweden (B.M.H., B.N., A.L.); Department of Neurology and Rehabilitation Medicine, Skåne University Hospital, Lund, Sweden (B.M.H., B.N., A.L.); and Division of Brain Injury Outcomes, Johns Hopkins Medical Institutions, Baltimore, MD (N.U., D.F.H.).
Bo
B
Norrving
From the Department of Clinical Sciences, Neurology, Lund University, Sweden (B.M.H., B.N., A.L.); Department of Neurology and Rehabilitation Medicine, Skåne University Hospital, Lund, Sweden (B.M.H., B.N., A.L.); and Division of Brain Injury Outcomes, Johns Hopkins Medical Institutions, Baltimore, MD (N.U., D.F.H.).
Daniel F
DF
Hanley
From the Department of Clinical Sciences, Neurology, Lund University, Sweden (B.M.H., B.N., A.L.); Department of Neurology and Rehabilitation Medicine, Skåne University Hospital, Lund, Sweden (B.M.H., B.N., A.L.); and Division of Brain Injury Outcomes, Johns Hopkins Medical Institutions, Baltimore, MD (N.U., D.F.H.).
Arne
A
Lindgren
D002543:Cerebral Hemorrhage / Q000628:therapy*; D006801:Humans; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic; D020521:Stroke / Q000628:therapy*
cerebral hemorrhage; clinical trials as topic; decision making; patient selection; stroke