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.
European Journal of Clinical Investigation · 2005-04-30 · Study protocol
Abstract
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.
Abstract © the authors or publisher, via PubMed. Reuse and removal
Tags
Antithrombotics & thrombolytics · Cardiovascular drugs · Mortality & survival · Quality of life & function · Thrombolytics · Vasopressors
Related articles
- ["Highlights" in emergency medicine -- severe head trauma, polytrauma and cardiac arrest]. (Anasthesiol Intensivmed Notfallmed Schmerzther, 2005)
- Circulatory collapse, right ventricular dilatation, and alveolar dead space: A triad for the rapid diagnosis of massive pulmonary embolism. (Am J Emerg Med, 2017)
- Comparative Efficacy and Safety of Intravenous Vasopressors in Pre-Hospital Cardiac Arrest: A Systematic Review and Meta-Analysis. (J Emerg Med, 2025)
- Vasopressin or epinephrine for out-of-hospital cardiac arrest. (Ann Emerg Med, 2006)
- Impact of Early Vasopressor Administration on Neurological Outcomes after Prolonged Out-of-Hospital Cardiac Arrest. (Prehosp Disaster Med, 2017)
- Thrombolysis during resuscitation for out-of-hospital cardiac arrest. (N Engl J Med, 2008)