Background and purpose: To evaluate prerequisites, safety, and efficacy of i.v.-thrombolysis of ischemic stroke with rtPA in an academic medical center.
Methods: Over a period of 2 years and 10 months all patients admitted with a diagnosis of stroke were recruited. Inclusion and exclusion criteria for i.v.-thrombolysis were combined from large scale randomized controlled trials, the time window, however, could be extended up to 4 hours in subjects with a negative CT-scan. Prespecified outcome parameters were the modified Rankin Scale (mRS) and the Barthel Index (BI) at 3 months, and symptomatic hemorrhagic complications. Additionally, time parameters, such as onset-admission-time, door-Ct-time, door-needle time, and onset-needle time were recorded.
Results: During the reported period 103 patients underwent i.v.-thrombolysis, corresponding to 14.9% of all patients with ischemic stroke, and 47% of patients with ischemic stroke arriving in < 3 hours after symptom onset. The mean baseline NIHSS was 14, the mean mRS 13 (3-34), the mean age 70 (+/- 12) years. The following time intervals were observed: Onset-admission-time 64 min., door-CT-time 27 min., admission-needle-time 80 min., and onset-needle-time 142 min. There were 4 symptomatic intracerebral hemorrhagic transformations, including 3 parenchymal hemorrhages, 2 of them lethal, and one with almost full recovery. According to the mRS, 39% of patients had a good (mRS 0-1), 72% a good to moderate recovery (mRS 0-2). The corresponding figures for the BI were 60% BI 95-100 and 72% BI > 90. The mortality was 15%.
Conclusion: The i.v.-thrombolysis of ischemic stroke with rt-PA demands appropriate organisation of the pre- and in-hospital phase and can be performed safely and efficaciously in daily clinical routine if inclusion and exclusion criteria as well as all safety measures during the critical phase after therapy are strictly obeyed.