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Safe implementation of thrombolysis in stroke-monitoring study in Italy.

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Title: Safe implementation of thrombolysis in stroke-monitoring study in Italy.
Authors: Lorenzano, S., Ahmed, N., Rosselli, A., Marcello, N., Inzitari, D., Sterzi, R., Wahlgren, N., Prencipe, M., Toni, D.
Source: European Journal of Neurology. Jan2010, Vol. 17 Issue 1, p163-167. 5p. 3 Charts.
Subjects: Thrombolytic therapy, Slosson Intelligence Test, Randomized controlled trials, Medical experimentation on humans
Geographic Terms: Italy
Abstract: Background and purpose: The safe implementation of thrombolysis in stroke-monitoring (SITS-MOST) study was an unique opportunity to test in Italy, where only few centres were expert in thrombolytic treatment before, safety and efficacy of i.v. alteplase within 3 h of ischaemic stroke outside the setting of clinical trials. Methods: In Italy to participate in the study the clinical centres had to possess organizational and structural characteristics certified by Regional Health Authorities. Results: Seventy-one centres were activated, 56 (79%) treated patients of which 41 (73%) had never used thrombolysis before the study. Globally, 586 patients were included. Baseline median National Institute of Health Stroke Scale of Italian patients was 13 vs. 12 in other European centres ( P = 0.0001). Symptomatic intracerebral haemorrhage as per the NINDS/Cochrane definition, mortality and independence (modified Rankin Scale 0–2) rates at 3 months occurred respectively in 6.7% (95% CI: 4.8–9.1), 11.7% (9.2–14.6) and 51.6% (47.4–55.7) of Italian patients compared with 7.3% (6.7–8.0) ( P = 0.56), 11.2% (10.4–12.1) ( P = 0.75) and 55.1% (53.8–56.4) ( P = 0.09) in the European patients and in 8.6% (40/65; 6.3–11.6), 17.3% (14.1–21.1) and 50.1% (44.5–54.7) of the patients treated in the pooled randomized controlled trials. Conclusions: The SITS-MOST study showed that in Italy i.v. alteplase is safe and effective in routine clinical use also in non-expert centres. [ABSTRACT FROM AUTHOR]
Copyright of European Journal of Neurology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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  Data: Safe implementation of thrombolysis in stroke-monitoring study in Italy.
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  Data: <searchLink fieldCode="AR" term="%22Lorenzano%2C+S%2E%22">Lorenzano, S.</searchLink><br /><searchLink fieldCode="AR" term="%22Ahmed%2C+N%2E%22">Ahmed, N.</searchLink><br /><searchLink fieldCode="AR" term="%22Rosselli%2C+A%2E%22">Rosselli, A.</searchLink><br /><searchLink fieldCode="AR" term="%22Marcello%2C+N%2E%22">Marcello, N.</searchLink><br /><searchLink fieldCode="AR" term="%22Inzitari%2C+D%2E%22">Inzitari, D.</searchLink><br /><searchLink fieldCode="AR" term="%22Sterzi%2C+R%2E%22">Sterzi, R.</searchLink><br /><searchLink fieldCode="AR" term="%22Wahlgren%2C+N%2E%22">Wahlgren, N.</searchLink><br /><searchLink fieldCode="AR" term="%22Prencipe%2C+M%2E%22">Prencipe, M.</searchLink><br /><searchLink fieldCode="AR" term="%22Toni%2C+D%2E%22">Toni, D.</searchLink>
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  Data: <searchLink fieldCode="JN" term="%22European+Journal+of+Neurology%22">European Journal of Neurology</searchLink>. Jan2010, Vol. 17 Issue 1, p163-167. 5p. 3 Charts.
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  Data: <searchLink fieldCode="DE" term="%22Thrombolytic+therapy%22">Thrombolytic therapy</searchLink><br /><searchLink fieldCode="DE" term="%22Slosson+Intelligence+Test%22">Slosson Intelligence Test</searchLink><br /><searchLink fieldCode="DE" term="%22Randomized+controlled+trials%22">Randomized controlled trials</searchLink><br /><searchLink fieldCode="DE" term="%22Medical+experimentation+on+humans%22">Medical experimentation on humans</searchLink>
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  Data: <searchLink fieldCode="DE" term="%22Italy%22">Italy</searchLink>
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  Data: Background and purpose: The safe implementation of thrombolysis in stroke-monitoring (SITS-MOST) study was an unique opportunity to test in Italy, where only few centres were expert in thrombolytic treatment before, safety and efficacy of i.v. alteplase within 3 h of ischaemic stroke outside the setting of clinical trials. Methods: In Italy to participate in the study the clinical centres had to possess organizational and structural characteristics certified by Regional Health Authorities. Results: Seventy-one centres were activated, 56 (79%) treated patients of which 41 (73%) had never used thrombolysis before the study. Globally, 586 patients were included. Baseline median National Institute of Health Stroke Scale of Italian patients was 13 vs. 12 in other European centres ( P = 0.0001). Symptomatic intracerebral haemorrhage as per the NINDS/Cochrane definition, mortality and independence (modified Rankin Scale 0–2) rates at 3 months occurred respectively in 6.7% (95% CI: 4.8–9.1), 11.7% (9.2–14.6) and 51.6% (47.4–55.7) of Italian patients compared with 7.3% (6.7–8.0) ( P = 0.56), 11.2% (10.4–12.1) ( P = 0.75) and 55.1% (53.8–56.4) ( P = 0.09) in the European patients and in 8.6% (40/65; 6.3–11.6), 17.3% (14.1–21.1) and 50.1% (44.5–54.7) of the patients treated in the pooled randomized controlled trials. Conclusions: The SITS-MOST study showed that in Italy i.v. alteplase is safe and effective in routine clinical use also in non-expert centres. [ABSTRACT FROM AUTHOR]
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  Data: <i>Copyright of European Journal of Neurology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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