{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,22]],"date-time":"2026-01-22T12:44:41Z","timestamp":1769085881182,"version":"3.49.0"},"reference-count":23,"publisher":"Oxford University Press (OUP)","issue":"4","license":[{"start":{"date-parts":[[2025,12,13]],"date-time":"2025-12-13T00:00:00Z","timestamp":1765584000000},"content-version":"vor","delay-in-days":12,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2025,12,1]],"date-time":"2025-12-01T00:00:00Z","timestamp":1764547200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2025,12,1]],"date-time":"2025-12-01T00:00:00Z","timestamp":1764547200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2025,12,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Intravenous thrombolysis (IVT) is not approved for acute ischemic stroke in certain patient groups due to in- and exclusion criteria from mostly early clinical trials. In a real-life setting, we analyzed frequencies, outcomes and complications of off-label-IVT compared to on-label-IVT and no IVT to contribute to rational decision-making regarding patient selection for IVT.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>Patients in the Berlin Specific Acute Therapy in Ischemic or hAemorrhagic stroke with Long-term follow-up registry were divided into three groups (on-label, off-label, non-IVT-treated). Off-label criteria were age\u2009&amp;gt;\u200980\u2009years, time from onset &amp;gt;4.5\u2009h, mild (National Institutes of Health Stroke Scale [NIHSS]\u2009&amp;lt;\u20095) or severe (NIHSS\u2009&amp;gt;\u200925) stroke, and a history of prior stroke and diabetes mellitus, as those criteria applied during the study period. Outcomes of interest were the 90-day modified Rankin Scale (mRS), symptomatic intracranial hemorrhage (sICH), in-hospital- and 90-day-mortality. After multiple imputation, we performed multivariable logistic regression to calculate adjusted common odds ratios (cOR) with 95% confidence intervals (CI) for mRS and risk ratios for secondary outcome measures.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>We analyzed 1875 on-label, 2881 off-label, and 4639 non-treated patients. The most common off-label-criteria were mild symptoms (44.6%) and older age (33.6%). Off-label-treated patients had no worse functional outcome when compared to on-label-treated patients (cOR 0.89, CI 0.78\u20131.02), but better outcome compared to non-treated patients (cOR 0.83, CI 0.76\u20130.91). No associations were found for sICH or mortality.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>Our results suggest a beneficial effect of off-label treatment in clinical practice, which warrants further investigation into treatment in relevant subgroups and an extension of the product license.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/23969873251329875","type":"journal-article","created":{"date-parts":[[2025,4,11]],"date-time":"2025-04-11T15:36:16Z","timestamp":1744385776000},"page":"1328-1336","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["Off-label thrombolysis in acute ischemic stroke patients: Frequencies and outcome compared to on-label and no treatment"],"prefix":"10.1093","volume":"10","author":[{"ORCID":"https:\/\/orcid.org\/0009-0000-6465-1951","authenticated-orcid":false,"given":"D\u00e9sir\u00e9e","family":"Mohrbach","sequence":"first","affiliation":[{"name":"Center for Stroke Research Berlin, Berlin, Germany 1"},{"name":"Klinik und Hochschulambulanz f\u00fcr Neurologie mit experimenteller Neurologie, Charit\u00e9 \u2013 Universit\u00e4tsmedizin Berlin, Berlin, Germany 2"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2323-6484","authenticated-orcid":false,"given":"Lora","family":"Wagner","sequence":"additional","affiliation":[{"name":"Center for Stroke Research Berlin, Berlin, Germany 1"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5577-1775","authenticated-orcid":false,"given":"Christian H","family":"Nolte","sequence":"additional","affiliation":[{"name":"Center for Stroke Research Berlin, Berlin, Germany 1"},{"name":"Klinik und Hochschulambulanz f\u00fcr Neurologie mit experimenteller Neurologie, Charit\u00e9 \u2013 Universit\u00e4tsmedizin Berlin, Berlin, Germany 2"},{"name":"Berlin Institute of Health, Berlin, Germany 3"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Martin","family":"Ebinger","sequence":"additional","affiliation":[{"name":"Klinik f\u00fcr Neurologie, Medical Park Berlin Humboldtm\u00fchle, Berlin, Germany 4"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Irina","family":"Lorenz-Meyer","sequence":"additional","affiliation":[{"name":"Center for Stroke Research Berlin, Berlin, Germany 1"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0072-524X","authenticated-orcid":false,"given":"Ira","family":"Rohrpasser-Napierkowski","sequence":"additional","affiliation":[{"name":"Berlin Institute of Health, Berlin, Germany 3"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter","family":"Harmel","sequence":"additional","affiliation":[{"name":"Center for Stroke Research Berlin, Berlin, Germany 1"},{"name":"Berlin Institute of Health, Berlin, Germany 3"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-4975-179X","authenticated-orcid":false,"given":"Georg","family":"Hagemann","sequence":"additional","affiliation":[{"name":"Helios Klinikum Berlin Buch, Berlin, Germany 5"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bruno-Marcel","family":"Mackert","sequence":"additional","affiliation":[{"name":"Klinik f\u00fcr Neurologie mit Stroke Unit, Vivantes Auguste-Viktoria-Klinikum, Berlin, Germany 6"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hans-Christian","family":"Koennecke","sequence":"additional","affiliation":[{"name":"Klinik f\u00fcr Neurologie mit Stroke Unit, Vivantes Klinikum im Friedrichshain, Berlin, Germany 7"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bob","family":"Siegerink","sequence":"additional","affiliation":[{"name":"Center for Stroke Research Berlin, Berlin, Germany 1"},{"name":"Department of Clinical Epidemiology, Leiden University Medical Center, Leiden University, Leiden, The Netherlands 8"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4785-0366","authenticated-orcid":false,"given":"Heinrich J","family":"Audebert","sequence":"additional","affiliation":[{"name":"Center for Stroke Research Berlin, Berlin, Germany 1"},{"name":"Klinik und Hochschulambulanz f\u00fcr Neurologie mit experimenteller Neurologie, Charit\u00e9 \u2013 Universit\u00e4tsmedizin Berlin, Berlin, Germany 2"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2025,12,1]]},"reference":[{"key":"2026012115064764400_bibr1-23969873251329875","doi-asserted-by":"crossref","DOI":"10.1161\/CIRCOUTCOMES.115.002097","article-title":"Changes in European label and guideline adherence after updated recommendations for stroke thrombolysis: results from the safe implementation of treatments in stroke registry","volume":"8","author":"Anani","year":"2015","journal-title":"Circ Cardiovasc Qual Outcomes"},{"key":"2026012115064764400_bibr2-23969873251329875","doi-asserted-by":"crossref","DOI":"10.1177\/2396987321989865","article-title":"European Stroke Organisation (ESO) guidelines on intravenous thrombolysis for acute ischaemic stroke","volume":"6","author":"Berge","year":"2021","journal-title":"Eur Stroke 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A retrospective analysis of data from a 5-year prospective database","volume":"178","author":"Sablot","year":"2022","journal-title":"Rev Neurol (Paris)"},{"key":"2026012115064764400_bibr8-23969873251329875","doi-asserted-by":"crossref","first-page":"615","DOI":"10.1111\/j.1747-4949.2011.00733.x","article-title":"Intravenous alteplase in ischemic stroke patients not fully adhering to the current drug license in Central and Eastern Europe","volume":"7","author":"Karlinski","year":"2012","journal-title":"Int J Stroke"},{"key":"2026012115064764400_bibr9-23969873251329875","doi-asserted-by":"crossref","DOI":"10.1136\/bmj.c6046","article-title":"Thrombolysis in very elderly people: controlled comparison of SITS international stroke thrombolysis registry and virtual international stroke trials archive","volume":"341","author":"Mishra","year":"2010","journal-title":"Br Med J"},{"key":"2026012115064764400_bibr10-23969873251329875","doi-asserted-by":"crossref","first-page":"2098","DOI":"10.1212\/WNL.0000000000002199","article-title":"IV thrombolysis in very severe and severe ischemic stroke: results from the SITS-ISTR registry","volume":"85","author":"Mazya","year":"2015","journal-title":"Neurology"},{"key":"2026012115064764400_bibr11-23969873251329875","doi-asserted-by":"crossref","first-page":"837","DOI":"10.1001\/jamaneurol.2013.406","article-title":"Results of intravenous thrombolysis within 4.5 to 6 hours and updated results within 3 to 4.5 hours of onset of acute ischemic stroke recorded in the safe implementation of treatment in stroke international stroke thrombolysis register (SITS-ISTR): an observational study","volume":"70","author":"Ahmed","year":"2013","journal-title":"JAMA Neurol"},{"key":"2026012115064764400_bibr12-23969873251329875","doi-asserted-by":"crossref","first-page":"390","DOI":"10.1111\/j.1468-1331.2011.03517.x","article-title":"Off-label intravenous thrombolysis in acute stroke","volume":"19","author":"Guillan","year":"2012","journal-title":"Eur J Neurol"},{"key":"2026012115064764400_bibr13-23969873251329875","unstructured":"Actilyse. 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