- 作者：Opeolu Adeoye ; MD&lowast ; ; &dagger ; ; &Dagger ; ; opeolu.adeoye@uc.edu ; Arthur Pancioli ; MD&lowast ; ; &dagger ; ; Jane Khoury ; PhD§ ; ; Charles J. Moomaw ; PhD¶ ; ; Pamela Schmit ; RN ; BSN&dagger ; ; Irene Ewing ; RN ; BSN&dagger ; ; Kathleen Alwell ; BSN¶ ; ; Matthew L. Flaherty ; MD&lowast ; ; ¶ ; ; Daniel Woo ; MD&lowast ; ; ¶ ; ; Simona Ferioli ; MD&lowast ; ; ¶ ; ; Pooja Khatri ; MD&lowast ; ; ¶ ; ; Joseph P. Broderick ; MD&lowast ; ; ¶ ; ; Brett M. Kissela ; MD&lowast ; ; ¶ ; ; Dawn Kleindorfer ; MD&lowast ; ; ¶ ;
- 关键词：Acute stroke ; clinical trials ; emergency medicine ; thrombolysis
- 刊名：Journal of Stroke and Cerebrovascular Diseases
- 出版年：2012
- 出版时间：November, 2012
- 年：2012
- 卷：21
- 期：8
- 页码：667-672
- 全文大小：79 K
Background
Recruitment challenges are common in acute stroke clinical trials. In a population-based study, we determined eligibility and actual enrollment for a successful, phase II acute stroke clinical trial. We hypothesized that missed opportunities for enrollment of eligible patients occurred frequently, despite the success of the trial.Methods
In 2005, acute ischemic stroke (AIS) cases in our region were identified at all 17 local hospitals as part of an epidemiologic study. The Combined Approach to Lysis Utilizing Eptifibatide and Recombinant Tissue Plasminogen Activator (CLEAR) trial assessed the safety of this combination in AIS patients within 3 hours of symptom onset. In 2005, we determined the proportion of AIS patients who were eligible for CLEAR and the proportion that were actually enrolled.
Results
At 8 participating hospitals, 33 (2.8 % ) of 1175 AIS patients were eligible for CLEAR. Of 33 eligible patients, 18 (54.5 % ) were approached for enrollment, 4 (12.1 % ) refused, 1 (3.0 % ) was not consentable, and 13 (39.4 % ) were enrolled. Of the 15 not approached for enrollment in the trial, 10 were evaluated by the stroke team; 7 received recombinant tissue plasminogen activator. Enrollment was not associated with night or weekend presentation.
Conclusions
Although the CLEAR trial was successful in meeting its delineated recruitment goals, our findings suggest enrollment could have been more efficient. Three out of 4 patients approached for enrollment participated in the trial. Eligible patients who were not approached and those treated with recombinant tissue plasminogen activator but not enrolled represent targets for improving enrollment rates.