| International multicentre trial protocol to assess the efficacy and safety of tenecteplase during cardiopulmonary resuscitation in patients with out-of-hospital cardiac arrest: the Thrombolysis in Cardiac Arrest (TROICA) Study. | |
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MedLine Citation:
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PMID: 15860043 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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Prehospital cardiac arrest has been associated with a very poor prognosis. Acute myocardial infarction and massive pulmonary embolism are the underlying causes of out-of-hospital cardiac arrest in 50-70% of patients. Although fibrinolysis is an effective treatment strategy for both myocardial infarction and pulmonary embolism, clinical experience for this therapy performed during resuscitation has been limited owing to the anticipated risk of severe bleeding complications. The TROICA study is planned as one of the largest randomized, double-blind, placebo-controlled trials to assess the efficacy and safety of prehospital thrombolytic therapy in cardiac arrest of presumed cardiac origin. Approximately 1000 patients with cardiac arrest will be randomized at approximately 60 international study centres to receive either a weight-adjusted dose of tenecteplase or placebo after the first dose of a vasopressor. Patients can be included if they are at least 18 years, presenting with a witnessed cardiac arrest of presumed cardiac origin, and if either basic life support had started within 10 min of onset and had been performed up to 10 min or advanced life support is started within 10 min of onset of cardiac arrest. Primary endpoint of the study is the 30-day survival rate, and the coprimary endpoint is hospital admission. Secondary endpoints are the return of spontaneous circulation (ROSC), survival after 24 h, survival to hospital discharge, and neurological performance. Safety endpoints include major bleeding complications and symptomatic intracranial haemorrhage. |
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Authors:
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F Spöhr; H R Arntz; E Bluhmki; C Bode; P Carli; D Chamberlain; T Danays; J Poth; C Skamira; V Wenzel; B W Böttiger |
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Publication Detail:
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Type: Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial |
Journal Detail:
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Title: European journal of clinical investigation Volume: 35 ISSN: 0014-2972 ISO Abbreviation: Eur. J. Clin. Invest. Publication Date: 2005 May |
Date Detail:
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Created Date: 2005-04-29 Completed Date: 2005-08-29 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 0245331 Medline TA: Eur J Clin Invest Country: England |
Other Details:
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Languages: eng Pagination: 315-23 Citation Subset: IM |
Affiliation:
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Department of Anaesthesiology, University of Heidelberg, Heidelberg, Germany. |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Adolescent Adult Cardiopulmonary Resuscitation / ethics, methods* Clinical Protocols Double-Blind Method Fibrinolytic Agents / administration & dosage*, adverse effects Heart Arrest / drug therapy, mortality, therapy* Hospitalization Humans Informed Consent Injections, Intravenous Prospective Studies Tissue Plasminogen Activator / administration & dosage*, adverse effects Treatment Outcome |
| Chemical | |
Reg. No./Substance:
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0/Fibrinolytic Agents; 0/tenecteplase; EC 3.4.21.68/Tissue Plasminogen Activator |
| Comments/Corrections | |
Comment In:
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Eur J Clin Invest. 2005 May;35(5):287-9
[PMID:
15860040
]
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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