Comparison of Pre-hospital and In-hospital Iv-tPA Stroke Treatment
NCT ID: NCT02358772
Last Updated: 2016-08-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
658 participants
OBSERVATIONAL
2011-02-28
2016-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Pre-hospital thrombolysis
Patients with acute ischemic stroke who are cared in a specialized STroke Emergency MObile (STEMO) before admission to the Hospital and receive thrombolytic therapy (either in STEMO or in Hospital).
thrombolysis in a pre-hospital setting (STEMO concept)
In-hospital thrombolysis
Patients with acute ischemic stroke who receive thrombolytic therapy after admission to an University Hospital.
No interventions assigned to this group
Interventions
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thrombolysis in a pre-hospital setting (STEMO concept)
Eligibility Criteria
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Inclusion Criteria
* Admission via EMS
* Known premorbid status of need of assistance
* NIHSS before treatment available
* Time of onset (or last well seen) between 4:00am and 10:30pm
Exclusion Criteria
* In-hospital thrombolysis despite decision against treatment because of contraindications in STEMO
18 Years
ALL
No
Sponsors
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Charite University, Berlin, Germany
OTHER
Responsible Party
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Heinrich J Audebert
Prof. Dr. med.
Principal Investigators
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Heinrich J Audebert, MD
Role: PRINCIPAL_INVESTIGATOR
Center for Stroke Research Berlin, Charité Universitätsmedizin Berlin
Locations
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Charité
Berlin, State of Berlin, Germany
Countries
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References
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Ebinger M, Winter B, Wendt M, Weber JE, Waldschmidt C, Rozanski M, Kunz A, Koch P, Kellner PA, Gierhake D, Villringer K, Fiebach JB, Grittner U, Hartmann A, Mackert BM, Endres M, Audebert HJ; STEMO Consortium. Effect of the use of ambulance-based thrombolysis on time to thrombolysis in acute ischemic stroke: a randomized clinical trial. JAMA. 2014 Apr 23-30;311(16):1622-31. doi: 10.1001/jama.2014.2850.
Kunz A, Ebinger M, Geisler F, Rozanski M, Waldschmidt C, Weber JE, Wendt M, Winter B, Zieschang K, Fiebach JB, Villringer K, Erdur H, Scheitz JF, Tutuncu S, Bollweg K, Grittner U, Kaczmarek S, Endres M, Nolte CH, Audebert HJ. Functional outcomes of pre-hospital thrombolysis in a mobile stroke treatment unit compared with conventional care: an observational registry study. Lancet Neurol. 2016 Sep;15(10):1035-43. doi: 10.1016/S1474-4422(16)30129-6. Epub 2016 Jul 16.
Nolte CH, Ebinger M, Scheitz JF, Kunz A, Erdur H, Geisler F, Braemswig TB, Rozanski M, Weber JE, Wendt M, Zieschang K, Fiebach JB, Villringer K, Grittner U, Kaczmarek S, Endres M, Audebert HJ. Effects of Prehospital Thrombolysis in Stroke Patients With Prestroke Dependency. Stroke. 2018 Mar;49(3):646-651. doi: 10.1161/STROKEAHA.117.019060. Epub 2018 Feb 19.
Other Identifiers
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STEMO_Outcome Analysis
Identifier Type: -
Identifier Source: org_study_id
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