Diagnosis and treatment of patients with stroke in a mobile stroke unit versus in hospital: a randomised controlled trial
Summary Background Only 2–5% of patients who have a stroke receive thrombolytic treatment, mainly because of delay in reaching the hospital. We aimed to assess the efficacy of a new approach of diagnosis and treatment starting at the emergency site, rather than after hospital arrival, in reducing de...
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| Veröffentlicht in: | Lancet neurology 2012-05, Vol.11 (5), p.397-404 |
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| creator | Walter, Silke, MD Kostopoulos, Panagiotis, MD Haass, Anton, Prof Keller, Isabel, MD Lesmeister, Martin Schlechtriemen, Thomas, MD Roth, Christian, MD Papanagiotou, Panagiotis, MD Grunwald, Iris, Prof Schumacher, Helmut, PhD Helwig, Stephan Viera, Julio Körner, Heiko Alexandrou, Maria Yilmaz, Umut, MD Ziegler, Karin, MD Schmidt, Kathrin, MD Dabew, Rainer Kubulus, Darius, MD Liu, Yang, MD Volk, Thomas, Prof Kronfeld, Kai, MD Ruckes, Christian, PhD Bertsch, Thomas, MD Reith, Wolfgang, Prof Fassbender, Klaus, Prof |
| description | Summary Background Only 2–5% of patients who have a stroke receive thrombolytic treatment, mainly because of delay in reaching the hospital. We aimed to assess the efficacy of a new approach of diagnosis and treatment starting at the emergency site, rather than after hospital arrival, in reducing delay in stroke therapy. Methods We did a randomised single-centre controlled trial to compare the time from alarm (emergency call) to therapy decision between mobile stroke unit (MSU) and hospital intervention. For inclusion in our study patients needed to be aged 18–80 years and have one or more stroke symptoms that started within the previous 2·5 h. In accordance with our week-wise randomisation plan, patients received either prehospital stroke treatment in a specialised ambulance (equipped with a CT scanner, point-of-care laboratory, and telemedicine connection) or optimised conventional hospital-based stroke treatment (control group) with a 7 day follow-up. Allocation was not masked from patients and investigators. Our primary endpoint was time from alarm to therapy decision, which was analysed with the Mann-Whitney U test. Our secondary endpoints included times from alarm to end of CT and to end of laboratory analysis, number of patients receiving intravenous thrombolysis, time from alarm to intravenous thrombolysis, and neurological outcome. We also assessed safety endpoints. This study is registered with ClinicalTrials.gov , number NCT00792220. Findings We stopped the trial after our planned interim analysis at 100 of 200 planned patients (53 in the prehospital stroke treatment group, 47 in the control group), because we had met our prespecified criteria for study termination. Prehospital stroke treatment reduced the median time from alarm to therapy decision substantially: 35 min (IQR 31–39) versus 76 min (63–94), p |
| doi_str_mv | 10.1016/S1474-4422(12)70057-1 |
| format | Article |
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We aimed to assess the efficacy of a new approach of diagnosis and treatment starting at the emergency site, rather than after hospital arrival, in reducing delay in stroke therapy. Methods We did a randomised single-centre controlled trial to compare the time from alarm (emergency call) to therapy decision between mobile stroke unit (MSU) and hospital intervention. For inclusion in our study patients needed to be aged 18–80 years and have one or more stroke symptoms that started within the previous 2·5 h. In accordance with our week-wise randomisation plan, patients received either prehospital stroke treatment in a specialised ambulance (equipped with a CT scanner, point-of-care laboratory, and telemedicine connection) or optimised conventional hospital-based stroke treatment (control group) with a 7 day follow-up. Allocation was not masked from patients and investigators. Our primary endpoint was time from alarm to therapy decision, which was analysed with the Mann-Whitney U test. Our secondary endpoints included times from alarm to end of CT and to end of laboratory analysis, number of patients receiving intravenous thrombolysis, time from alarm to intravenous thrombolysis, and neurological outcome. We also assessed safety endpoints. This study is registered with ClinicalTrials.gov , number NCT00792220. Findings We stopped the trial after our planned interim analysis at 100 of 200 planned patients (53 in the prehospital stroke treatment group, 47 in the control group), because we had met our prespecified criteria for study termination. Prehospital stroke treatment reduced the median time from alarm to therapy decision substantially: 35 min (IQR 31–39) versus 76 min (63–94), p<0·0001; median difference 41 min (95% CI 36–48 min). We also detected similar gains regarding times from alarm to end of CT, and alarm to end of laboratory analysis, and to intravenous thrombolysis for eligible ischaemic stroke patients, although there was no substantial difference in number of patients who received intravenous thrombolysis or in neurological outcome. Safety endpoints seemed similar across the groups. Interpretation For patients with suspected stroke, treatment by the MSU substantially reduced median time from alarm to therapy decision. The MSU strategy offers a potential solution to the medical problem of the arrival of most stroke patients at the hospital too late for treatment. Funding Ministry of Health of the Saarland, Germany, the Werner-Jackstädt Foundation, the Else-Kröner-Fresenius Foundation, and the Rettungsstiftung Saar.</description><identifier>ISSN: 1474-4422</identifier><identifier>EISSN: 1474-4465</identifier><identifier>DOI: 10.1016/S1474-4422(12)70057-1</identifier><identifier>PMID: 22497929</identifier><identifier>CODEN: LANCAO</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject>Aged ; Angioplasty ; Clinical medicine ; Clinical trials ; Critical Care - organization & administration ; Diagnosis, Differential ; Early Medical Intervention - organization & administration ; Emergency medical care ; Emergency Medical Services - organization & administration ; Female ; Hospitals ; Humans ; Informed consent ; Intravenous administration ; Ischemia ; Laboratories ; Male ; Medical diagnosis ; Middle Aged ; Mobile Health Units - organization & administration ; Motor task performance ; Neurology ; Paresis ; Patients ; Stroke ; Stroke - diagnosis ; Stroke - mortality ; Stroke - therapy ; Survival Analysis ; Telemedicine ; thrombolysis ; Thrombolytic Therapy ; Time and Motion Studies ; Vocalization behavior</subject><ispartof>Lancet neurology, 2012-05, Vol.11 (5), p.397-404</ispartof><rights>Elsevier Ltd</rights><rights>2012 Elsevier Ltd</rights><rights>Copyright © 2012 Elsevier Ltd. All rights reserved.</rights><rights>Copyright Elsevier Limited May 2012</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c533t-37866c8da5907f8e6b381d370c0787cf94f590c727c84b248d1b9cea8e18bd143</citedby><cites>FETCH-LOGICAL-c533t-37866c8da5907f8e6b381d370c0787cf94f590c727c84b248d1b9cea8e18bd143</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S1474442212700571$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65534</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22497929$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Walter, Silke, MD</creatorcontrib><creatorcontrib>Kostopoulos, Panagiotis, MD</creatorcontrib><creatorcontrib>Haass, Anton, Prof</creatorcontrib><creatorcontrib>Keller, Isabel, MD</creatorcontrib><creatorcontrib>Lesmeister, Martin</creatorcontrib><creatorcontrib>Schlechtriemen, Thomas, MD</creatorcontrib><creatorcontrib>Roth, Christian, MD</creatorcontrib><creatorcontrib>Papanagiotou, Panagiotis, MD</creatorcontrib><creatorcontrib>Grunwald, Iris, Prof</creatorcontrib><creatorcontrib>Schumacher, Helmut, PhD</creatorcontrib><creatorcontrib>Helwig, Stephan</creatorcontrib><creatorcontrib>Viera, Julio</creatorcontrib><creatorcontrib>Körner, Heiko</creatorcontrib><creatorcontrib>Alexandrou, Maria</creatorcontrib><creatorcontrib>Yilmaz, Umut, MD</creatorcontrib><creatorcontrib>Ziegler, Karin, MD</creatorcontrib><creatorcontrib>Schmidt, Kathrin, MD</creatorcontrib><creatorcontrib>Dabew, Rainer</creatorcontrib><creatorcontrib>Kubulus, Darius, MD</creatorcontrib><creatorcontrib>Liu, Yang, MD</creatorcontrib><creatorcontrib>Volk, Thomas, Prof</creatorcontrib><creatorcontrib>Kronfeld, Kai, MD</creatorcontrib><creatorcontrib>Ruckes, Christian, PhD</creatorcontrib><creatorcontrib>Bertsch, Thomas, MD</creatorcontrib><creatorcontrib>Reith, Wolfgang, Prof</creatorcontrib><creatorcontrib>Fassbender, Klaus, Prof</creatorcontrib><title>Diagnosis and treatment of patients with stroke in a mobile stroke unit versus in hospital: a randomised controlled trial</title><title>Lancet neurology</title><addtitle>Lancet Neurol</addtitle><description>Summary Background Only 2–5% of patients who have a stroke receive thrombolytic treatment, mainly because of delay in reaching the hospital. We aimed to assess the efficacy of a new approach of diagnosis and treatment starting at the emergency site, rather than after hospital arrival, in reducing delay in stroke therapy. Methods We did a randomised single-centre controlled trial to compare the time from alarm (emergency call) to therapy decision between mobile stroke unit (MSU) and hospital intervention. For inclusion in our study patients needed to be aged 18–80 years and have one or more stroke symptoms that started within the previous 2·5 h. In accordance with our week-wise randomisation plan, patients received either prehospital stroke treatment in a specialised ambulance (equipped with a CT scanner, point-of-care laboratory, and telemedicine connection) or optimised conventional hospital-based stroke treatment (control group) with a 7 day follow-up. Allocation was not masked from patients and investigators. Our primary endpoint was time from alarm to therapy decision, which was analysed with the Mann-Whitney U test. Our secondary endpoints included times from alarm to end of CT and to end of laboratory analysis, number of patients receiving intravenous thrombolysis, time from alarm to intravenous thrombolysis, and neurological outcome. We also assessed safety endpoints. This study is registered with ClinicalTrials.gov , number NCT00792220. Findings We stopped the trial after our planned interim analysis at 100 of 200 planned patients (53 in the prehospital stroke treatment group, 47 in the control group), because we had met our prespecified criteria for study termination. Prehospital stroke treatment reduced the median time from alarm to therapy decision substantially: 35 min (IQR 31–39) versus 76 min (63–94), p<0·0001; median difference 41 min (95% CI 36–48 min). We also detected similar gains regarding times from alarm to end of CT, and alarm to end of laboratory analysis, and to intravenous thrombolysis for eligible ischaemic stroke patients, although there was no substantial difference in number of patients who received intravenous thrombolysis or in neurological outcome. Safety endpoints seemed similar across the groups. Interpretation For patients with suspected stroke, treatment by the MSU substantially reduced median time from alarm to therapy decision. The MSU strategy offers a potential solution to the medical problem of the arrival of most stroke patients at the hospital too late for treatment. Funding Ministry of Health of the Saarland, Germany, the Werner-Jackstädt Foundation, the Else-Kröner-Fresenius Foundation, and the Rettungsstiftung Saar.</description><subject>Aged</subject><subject>Angioplasty</subject><subject>Clinical medicine</subject><subject>Clinical trials</subject><subject>Critical Care - organization & administration</subject><subject>Diagnosis, Differential</subject><subject>Early Medical Intervention - organization & administration</subject><subject>Emergency medical care</subject><subject>Emergency Medical Services - organization & administration</subject><subject>Female</subject><subject>Hospitals</subject><subject>Humans</subject><subject>Informed consent</subject><subject>Intravenous administration</subject><subject>Ischemia</subject><subject>Laboratories</subject><subject>Male</subject><subject>Medical diagnosis</subject><subject>Middle Aged</subject><subject>Mobile Health Units - organization & administration</subject><subject>Motor task performance</subject><subject>Neurology</subject><subject>Paresis</subject><subject>Patients</subject><subject>Stroke</subject><subject>Stroke - diagnosis</subject><subject>Stroke - mortality</subject><subject>Stroke - therapy</subject><subject>Survival Analysis</subject><subject>Telemedicine</subject><subject>thrombolysis</subject><subject>Thrombolytic Therapy</subject><subject>Time and Motion Studies</subject><subject>Vocalization behavior</subject><issn>1474-4422</issn><issn>1474-4465</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNqNkc1u1TAQhSMEoqXwCCBLbMoi4L_EDguqqtCCVIkFsLYcZ0LdOvbFdoru2-Pc3BapG1hYtma-OeOZU1UvCX5LMGnffSNc8JpzSo8JfSMwbkRNHlWH-3DbPL5_U3pQPUvpGmNKuCRPqwNKeSc62h1W249W__Qh2YS0H1COoPMEPqMwoo3OtjwT-m3zFUo5hhtA1iONptBbB3eh2duMbiGmOS3pq5A2Nmv3voCxiIbJJhiQCb7gzsHSxWr3vHoyapfgxf4-qn6cf_p-9rm-_Hrx5ez0sjYNY7lmQratkYNuOixGCW3PJBmYwAYLKczY8bFkjKDCSN5TLgfSdwa0BCL7gXB2VB2vupsYfs2Qsir_MeCc9hDmpMo2eTmkwf-BYikZaQUr6OsH6HWYoy-DrFTTNG1bqGalTAwpRRjVJtpJx22Blsat2tmoFo8UoWpnoyKl7tVefe4nGO6r7nwrwMkKQNncrYWokileGRhsBJPVEOw_W3x4oGCc9dZodwNbSH-nUYkqvIosGoTuFAj7Ay52wSI</recordid><startdate>20120501</startdate><enddate>20120501</enddate><creator>Walter, Silke, MD</creator><creator>Kostopoulos, Panagiotis, MD</creator><creator>Haass, Anton, Prof</creator><creator>Keller, Isabel, MD</creator><creator>Lesmeister, Martin</creator><creator>Schlechtriemen, Thomas, MD</creator><creator>Roth, Christian, MD</creator><creator>Papanagiotou, Panagiotis, MD</creator><creator>Grunwald, Iris, Prof</creator><creator>Schumacher, Helmut, PhD</creator><creator>Helwig, Stephan</creator><creator>Viera, Julio</creator><creator>Körner, Heiko</creator><creator>Alexandrou, Maria</creator><creator>Yilmaz, Umut, MD</creator><creator>Ziegler, Karin, MD</creator><creator>Schmidt, Kathrin, MD</creator><creator>Dabew, Rainer</creator><creator>Kubulus, Darius, MD</creator><creator>Liu, Yang, MD</creator><creator>Volk, Thomas, Prof</creator><creator>Kronfeld, Kai, MD</creator><creator>Ruckes, Christian, PhD</creator><creator>Bertsch, Thomas, MD</creator><creator>Reith, Wolfgang, Prof</creator><creator>Fassbender, Klaus, Prof</creator><general>Elsevier Ltd</general><general>Elsevier Limited</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>0TZ</scope><scope>3V.</scope><scope>7RV</scope><scope>7TK</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88G</scope><scope>8AO</scope><scope>8C2</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>M2M</scope><scope>NAPCQ</scope><scope>PHGZM</scope><scope>PHGZT</scope><scope>PJZUB</scope><scope>PKEHL</scope><scope>PPXIY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>PSYQQ</scope><scope>Q9U</scope><scope>7X8</scope></search><sort><creationdate>20120501</creationdate><title>Diagnosis and treatment of patients with stroke in a mobile stroke unit versus in hospital: a randomised controlled trial</title><author>Walter, Silke, MD ; Kostopoulos, Panagiotis, MD ; Haass, Anton, Prof ; Keller, Isabel, MD ; Lesmeister, Martin ; Schlechtriemen, Thomas, MD ; Roth, Christian, MD ; Papanagiotou, Panagiotis, MD ; Grunwald, Iris, Prof ; Schumacher, Helmut, PhD ; Helwig, Stephan ; Viera, Julio ; Körner, Heiko ; Alexandrou, Maria ; Yilmaz, Umut, MD ; Ziegler, Karin, MD ; Schmidt, Kathrin, MD ; Dabew, Rainer ; Kubulus, Darius, MD ; Liu, Yang, MD ; Volk, Thomas, Prof ; Kronfeld, Kai, MD ; Ruckes, Christian, PhD ; Bertsch, Thomas, MD ; Reith, Wolfgang, Prof ; Fassbender, Klaus, Prof</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c533t-37866c8da5907f8e6b381d370c0787cf94f590c727c84b248d1b9cea8e18bd143</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>Aged</topic><topic>Angioplasty</topic><topic>Clinical medicine</topic><topic>Clinical trials</topic><topic>Critical Care - 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Academic</collection><jtitle>Lancet neurology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Walter, Silke, MD</au><au>Kostopoulos, Panagiotis, MD</au><au>Haass, Anton, Prof</au><au>Keller, Isabel, MD</au><au>Lesmeister, Martin</au><au>Schlechtriemen, Thomas, MD</au><au>Roth, Christian, MD</au><au>Papanagiotou, Panagiotis, MD</au><au>Grunwald, Iris, Prof</au><au>Schumacher, Helmut, PhD</au><au>Helwig, Stephan</au><au>Viera, Julio</au><au>Körner, Heiko</au><au>Alexandrou, Maria</au><au>Yilmaz, Umut, MD</au><au>Ziegler, Karin, MD</au><au>Schmidt, Kathrin, MD</au><au>Dabew, Rainer</au><au>Kubulus, Darius, MD</au><au>Liu, Yang, MD</au><au>Volk, Thomas, Prof</au><au>Kronfeld, Kai, MD</au><au>Ruckes, Christian, PhD</au><au>Bertsch, Thomas, MD</au><au>Reith, Wolfgang, Prof</au><au>Fassbender, Klaus, Prof</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Diagnosis and treatment of patients with stroke in a mobile stroke unit versus in hospital: a randomised controlled trial</atitle><jtitle>Lancet neurology</jtitle><addtitle>Lancet Neurol</addtitle><date>2012-05-01</date><risdate>2012</risdate><volume>11</volume><issue>5</issue><spage>397</spage><epage>404</epage><pages>397-404</pages><issn>1474-4422</issn><eissn>1474-4465</eissn><coden>LANCAO</coden><abstract>Summary Background Only 2–5% of patients who have a stroke receive thrombolytic treatment, mainly because of delay in reaching the hospital. We aimed to assess the efficacy of a new approach of diagnosis and treatment starting at the emergency site, rather than after hospital arrival, in reducing delay in stroke therapy. Methods We did a randomised single-centre controlled trial to compare the time from alarm (emergency call) to therapy decision between mobile stroke unit (MSU) and hospital intervention. For inclusion in our study patients needed to be aged 18–80 years and have one or more stroke symptoms that started within the previous 2·5 h. In accordance with our week-wise randomisation plan, patients received either prehospital stroke treatment in a specialised ambulance (equipped with a CT scanner, point-of-care laboratory, and telemedicine connection) or optimised conventional hospital-based stroke treatment (control group) with a 7 day follow-up. Allocation was not masked from patients and investigators. Our primary endpoint was time from alarm to therapy decision, which was analysed with the Mann-Whitney U test. Our secondary endpoints included times from alarm to end of CT and to end of laboratory analysis, number of patients receiving intravenous thrombolysis, time from alarm to intravenous thrombolysis, and neurological outcome. We also assessed safety endpoints. This study is registered with ClinicalTrials.gov , number NCT00792220. Findings We stopped the trial after our planned interim analysis at 100 of 200 planned patients (53 in the prehospital stroke treatment group, 47 in the control group), because we had met our prespecified criteria for study termination. Prehospital stroke treatment reduced the median time from alarm to therapy decision substantially: 35 min (IQR 31–39) versus 76 min (63–94), p<0·0001; median difference 41 min (95% CI 36–48 min). We also detected similar gains regarding times from alarm to end of CT, and alarm to end of laboratory analysis, and to intravenous thrombolysis for eligible ischaemic stroke patients, although there was no substantial difference in number of patients who received intravenous thrombolysis or in neurological outcome. Safety endpoints seemed similar across the groups. Interpretation For patients with suspected stroke, treatment by the MSU substantially reduced median time from alarm to therapy decision. The MSU strategy offers a potential solution to the medical problem of the arrival of most stroke patients at the hospital too late for treatment. Funding Ministry of Health of the Saarland, Germany, the Werner-Jackstädt Foundation, the Else-Kröner-Fresenius Foundation, and the Rettungsstiftung Saar.</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>22497929</pmid><doi>10.1016/S1474-4422(12)70057-1</doi><tpages>8</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1474-4422 |
| ispartof | Lancet neurology, 2012-05, Vol.11 (5), p.397-404 |
| issn | 1474-4422 1474-4465 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_1014101150 |
| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | Aged Angioplasty Clinical medicine Clinical trials Critical Care - organization & administration Diagnosis, Differential Early Medical Intervention - organization & administration Emergency medical care Emergency Medical Services - organization & administration Female Hospitals Humans Informed consent Intravenous administration Ischemia Laboratories Male Medical diagnosis Middle Aged Mobile Health Units - organization & administration Motor task performance Neurology Paresis Patients Stroke Stroke - diagnosis Stroke - mortality Stroke - therapy Survival Analysis Telemedicine thrombolysis Thrombolytic Therapy Time and Motion Studies Vocalization behavior |
| title | Diagnosis and treatment of patients with stroke in a mobile stroke unit versus in hospital: a randomised controlled trial |
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