Abstract
Background: Enrollment into acute ischemic stroke (AIS) trials is usually limited to weekday working hours. At our center, the majority of patients (64%) that receive tPA arrive after-hours. As a result, a large portion of eligible patients do not receive the opportunity to participate in these trials, hence enrollment rate suffers. Objectives: Demonstrate ongoing experience regarding feasibility and implementation of a 24/7 enrollment plan for an international AIS trial. Compare differences in patients’ characteristics enrolled during working hours ( WH - Mon-Fri 07:00-17:00) vs. after hours+weekend ( AH ). Methods: Data obtained from an on-going, multi-center, randomized, time-sensitive, tPA-adjunctive clinical trial (ARTSS-2; NCT01464788) Centers capable of doing so, implemented an on-call system for coordinators to respond AH. AH enrollment includes a coordinated effort to reduce time and meet the time challenges of screening, consent, randomization and starting study drug before the end of tPA infusion. The coordinator arrives at the ED to assist in-house physician with study procedures. We conducted descriptive analyses that explore differences between WH vs. AH . Results: As of 08/14, a total of 240 patients were eligible of which 75 were enrolled. Of these, 32 (43%) were enrolled AH at a total of 6 sites. 15 of 32 AH patients were enrolled at non-coordinating centers. AH patients were younger and more likely to be male (Table 1). Compared to WH, AH enrollment did not delay tPA initiation, time to website randomization, or initiation of study drug. No signal of increased harm or trial protocol deviations was evident between the two groups. Conclusion: 24/7 clinical trial enrollment is safe and feasible in a multicenter, international thrombolysis trial. We increased recruitment by 75% with no delays in randomization or initiation of study treatment. Efforts to provide 24/7 coverage should be implemented to improve trial recruitment rates.
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