Applicability of Clinical Trials in an Unselected Cohort of Patients With Intracerebral Hemorrhage.
Applicability of Clinical Trials in an Unselected Cohort of Patients With Intracerebral Hemorrhage.
复制标题
临床试验在未经选择的脑出血患者队列中的适用性。
DOI：
10.1161/strokeaha.116.014203
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发表时间：
2016
期刊：
影响因子：
8.3
通讯作者：
Lindgren,Arne
中科院分区：
文献类型：
--
作者：
Hansen,BjörnM;Ullman,Natalie;Norrving,Bo;Hanley,DanielF;Lindgren,Arne
背景和目的脑出血临床试验中患者的选择影响试验结果的整体适用性。我们估计资格完成，正在进行中，并计划在一个队列中的ICH患者ICH.MethodsLarge的临床ICH试验，确定使用试验注册数据库的临床试验。每项试验的入选标准均适用于来自前瞻性医院隆德卒中登记中心的连续ICH患者组。生存状态，从国家人口普查办公室和90天的功能不良的结果（修改后的兰金量表≥4）从瑞典中风登记册或medical files.ResultsAmong 253例ICH患者，估计合格的比例范围为2%和36%之间的11个确定的临床试验。不符合任何试验条件的患者（n=96）有更多的脑室内出血、较低的基线意识水平、较高的小脑ICH发生率和较低的脑叶ICH发生率（P≤ 0. 001）。30天内，不符合条件的患者的病死率为54%，而符合条件的患者的病死率为18%（95%置信区间，44%-64% vs 13%-25%;P<0.001）。不符合条件的ICH患者更经常有不良的功能结局（75%对48%; 95%置信区间，65%-83%对40%-56%;P<0.001）。
Background and PurposePatient 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.MethodsLarge 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.ResultsAmong 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).ConclusionsThere 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.