Thrombolysis Using Tenecteplase (Metalyse®) in Cardiac Arrest - The TROICA Trial
- Conditions
- Heart Arrest
- Registration Number
- NCT00157261
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The general aim of this study is to compare the efficacy and safety of tenecteplase to standard treatment during cardiopulmonary resuscitation in patients suffering from out-of-hospital cardiac arrest.
- Detailed Description
The trial is a prospective, international, multi-centre, randomised (1:1), double-blind, parallel group comparison conducted for investigating the efficacy and safety of tenecteplase and placebo in patients with cardiac arrest of presumed cardiac origin.
Approximately 1300 patients (two groups of 650 patients; tenecteplase or matching placebo) suffering from witnessed (by eye or ear) out-of-hospital cardiac arrest of presumed cardiac origin, who are treated with ALS-CPR will be randomised at approximately 40 study centres. Randomisation is done immediately after insertion of an IV line is established. Study drug application, as a single IV bolus over 5-10 seconds, should be done immediately after the first vasopressor application during the ALS-CPR procedure.
PCI facilities will be required at all participating sites, i.e. hospitals receiving patients.
Study Hypothesis:
The primary aim of the trial is to demonstrate superiority in the intent-to-treat analysis of tenecteplase over placebo with regard to primary endpoint as the incidence of 30-day survival (30daysurv).
Comparison(s):
Group A (experimental; fibrinolytic treatment) Tenecteplase, as a single IV bolus over 5-10 seconds, immediately after first vasopressor dosage during standardised ALS-CPR procedures according to the International CPR Guidelines.
Group B (reference) Placebo, as a single IV bolus over 5-10 seconds, immediately after first vasopressor dosage during standardised ALS-CPR procedures according to the International CPR Guidelines.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1050
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The primary endpoint of this study is the 30-day survival rate 30 days The co-primary endpoint of this study is hospital admission 30 days
- Secondary Outcome Measures
Name Time Method Return of spontaneous circulation (ROSC) 30 days Major bleeds up to hospital discharge or day 30, whichever came first 30 days Neurological and overall outcome at hospital discharge or at day 30, whichever came first 30 days 24-hr survival 24 hours Symptomatic intracranial haemorrhage (ICH) up to hospital discharge or day 30, whichever came first 30 days
Trial Locations
- Locations (67)
Univ.-Klinik f. Notfallmedizin
🇦🇹Wien, Austria
AZ VUB
🇧🇪Bruxelles, Belgium
AZ Groeningen
🇧🇪Kortrijk, Belgium
Algemeen Ziekenhuis Antwerpen / Campus Stuivenberg
🇧🇪Antwerpen, Belgium
ICU, Haukeland Universitetssykehus
🇳🇴Bergen, Norway
Södersjukhuset
🇸🇪Stockholm, Sweden
Ospedale S. Anna
🇮🇹Como, Italy
Hôpital Lapeyronie
🇫🇷Montpellier cedex 5, France
Hospital Universitario Reina Sofía / ICU
🇪🇸Cordoba, Spain
Hôpital Necker
🇫🇷Paris cedex 15, France
Hôpital Régional et Universitaire
🇫🇷Lille cedex, France
Univ.-Klinik f. Anaesthesie u. Intensivmedizin
🇦🇹Innsbruck, Austria
AZ Sint-Jan AV
🇧🇪Brugge, Belgium
CHU Saint-Pierre
🇧🇪Bruxelles, Belgium
CHR de la Citadelle
🇧🇪Liège, Belgium
Universitätsklinikum Benjamin Franklin
🇩🇪Berlin, Germany
LKH Salzburg, St. Johanns-Spital
🇦🇹Salzburg, Austria
Anestesikliniken
🇸🇪Gävle, Sweden
Universität Heidelberg
🇩🇪Heidelberg, Germany
Hôpital Marc Jacquet
🇫🇷Melun cedex, France
Hôpital André Mignot
🇫🇷Le Chesnay, France
Hospital Clinico Univ. Lozano Blesa
🇪🇸Zaragoza, Spain
Klinikum der Ruhr-Universität Bochum
🇩🇪Bochum, Germany
CHU de Tivoli
🇧🇪La Louvière, Belgium
CHR de Namur
🇧🇪Namur, Belgium
Hjärt/Kärlforskn.enheten, Sahlgrenska Univ.sjh. Göteborg
🇸🇪Göteborg, Sweden
Universitätsklinikum Schleswig-Holstein
🇩🇪Kiel, Germany
ICU, Sykehuset Østfold Fredrikstad
🇳🇴Fredrikstad, Norway
Hôpital Charles Nicolle
🇫🇷Rouen cedex, France
Hôpital Pierre Bazin
🇫🇷Voiron cedex, France
DRK Kliniken Westend
🇩🇪Berlin, Germany
Universitetssjukhuset
🇸🇪Örebro, Sweden
A. O. San Gerardo di Monza
🇮🇹Monza, Italy
Policlinico S. Matteo
🇮🇹Pavia, Italy
Osp. di Circolo Fondazione Macchi
🇮🇹Varese, Italy
Städtische Kliniken Bielefeld gem. GmbH
🇩🇪Bielefeld, Germany
Knappschaftskrankenhaus Dortmund
🇩🇪Dortmund, Germany
Hospital de Torrecárdenas / ICU
🇪🇸Almería, Spain
Hospital Clínico San Carlos / Hemodynamics
🇪🇸Madrid, Spain
Hospital Clínico Universitario Vírgen de la Victoria / ICU
🇪🇸Malaga, Spain
A. O. Ospedali Riuniti di Bergamo
🇮🇹Bergamo, Italy
Akuttklinikken / NLA, Sentralsjukehuset i Rogaland
🇳🇴Stavanger, Norway
A. O. Universitaria S. Martino
🇮🇹Genova, Italy
Hospital Clínico Provincial de BCN / Cardiology Service
🇪🇸Barcelona, Spain
Vírgen de las Nieves. Critical Care-Emergency Room
🇪🇸Granada, Spain
Centre interdisciplinaire des urgences (CIU), CHUV BH 06-429
🇨🇭Lausanne, Switzerland
Univ.-Klinik f. Anaesthesie Graz
🇦🇹Graz, Austria
Pre Hospital Klinikk, Sykehuset i Vestfold Tønsberg
🇳🇴Tønsberg, Norway
Cliniques Universitaires Saint-Luc
🇧🇪Bruxelles, Belgium
Martin-Luther-Universität Halle
🇩🇪Halle/Saale, Germany
Friedrich-Schiller Universität Jena
🇩🇪Jena, Germany
Klinikum rechts der Isar
🇩🇪München, Germany
Universitätsklinikum Ulm
🇩🇪Ulm, Germany
Berufsfeuerwehr Kiel
🇩🇪Kiel, Germany
Universitaire Ziekenhuizen Leuven
🇧🇪Leuven, Belgium
Hôpital Jean Minjoz
🇫🇷Besançon cedex, France
Hôpital Henri Mondor
🇫🇷Creteil cedex, France
Hôpital Avicenne
🇫🇷Bobigny cedex, France
Hôpital Purpan
🇫🇷Toulouse cedex, France
Humboldt-Klinikum
🇩🇪Berlin, Germany
Chirurgische Universität Freiburg
🇩🇪Freiburg/Breisgau, Germany
Georg-August Universität Göttingen
🇩🇪Göttingen, Germany
Universitätsklinikum Mannheim
🇩🇪Mannheim, Germany
Klinikum Saarbrücken gGmbH
🇩🇪Saarbrücken, Germany
Hospital de Jerez de la Frontera / ICU
🇪🇸Jerez de la Frontera, Spain
Boehringer Ingelheim Investigational Site
🇨🇭Lugano, Switzerland
Complejo Hospitalario Universitario de Vigo / Cardiology
🇪🇸Vigo, Spain