Thrombolysis Using Tenecteplase (Metalyse®) in Cardiac Arrest - The TROICA Trial
NCT ID: NCT00157261
Last Updated: 2013-10-29
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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TERMINATED
PHASE3
1050 participants
INTERVENTIONAL
2004-01-31
2006-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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tenecteplase
Eligibility Criteria
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Inclusion Criteria
* Out-of-hospital cardiac arrest of presumed cardiac origin (including recurrent cardiac arrest(s) after initial ROSC)
* Witnessed (by eye and/or ear) cardiac arrest
* BLS-CPR started within 10 min of onset (known or estimated time) and may be performed for up to 10 min, followed by ALS-CPR - or ALS-CPR started within 10 min of onset (known or estimated time)
Subjects who meet any of the following criteria will be excluded from randomisation into the study:
* In-hospital cardiac arrest
* Cardiac arrest of presumed non-cardiac origin (e.g., drug overdose, carbon monoxide poisoning, drowning, hypothermia, exsanguination, electrocution, asphyxia, hypoxia, trauma, cerebrovascular accident)
* Obvious significant internal bleeding
* Known neurological impairment
* Known coagulation disorder
* Known pregnancy
* Known current participation in any other clinical study
* Known hypersensitivity to study medication
* Institutionalised subjects (e.g., prisoner)
* Any other condition that the investigator feels would place the patient at increased risk if the investigational therapy is initiated
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Principal Investigators
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Boehringer Ingelheim Study Coordinator
Role: STUDY_CHAIR
B.I. Pharma GmbH & Co. KG
Locations
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Univ.-Klinik f. Anaesthesie Graz
Graz, , Austria
Univ.-Klinik f. Anaesthesie u. Intensivmedizin
Innsbruck, , Austria
LKH Salzburg, St. Johanns-Spital
Salzburg, , Austria
Univ.-Klinik f. Notfallmedizin
Vienna, , Austria
Algemeen Ziekenhuis Antwerpen / Campus Stuivenberg
Antwerp, , Belgium
AZ Sint-Jan AV
Bruges, , Belgium
CHU Saint-Pierre
Brussels, , Belgium
AZ VUB
Brussels, , Belgium
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
AZ Groeningen
Kortrijk, , Belgium
CHU de Tivoli
La Louvière, , Belgium
Universitaire Ziekenhuizen Leuven
Leuven, , Belgium
CHR de la Citadelle
Liège, , Belgium
CHR de Namur
Namur, , Belgium
Hôpital Jean Minjoz
Besançon, , France
Hôpital Avicenne
Bobigny, , France
Hôpital Henri Mondor
Créteil, , France
Hôpital André Mignot
Le Chesnay, , France
Hôpital Régional et Universitaire
Lille, , France
Hôpital Marc Jacquet
Melun, , France
Hôpital Lapeyronie
Montpellier, , France
Hôpital Necker
Paris, , France
Hôpital Charles Nicolle
Rouen, , France
Hôpital Purpan
Toulouse, , France
Hôpital Pierre Bazin
Voiron, , France
Universitätsklinikum Benjamin Franklin
Berlin, , Germany
Humboldt-Klinikum
Berlin, , Germany
DRK Kliniken Westend
Berlin, , Germany
Städtische Kliniken Bielefeld gem. GmbH
Bielefeld, , Germany
Klinikum der Ruhr-Universität Bochum
Bochum, , Germany
Knappschaftskrankenhaus Dortmund
Dortmund, , Germany
Chirurgische Universität Freiburg
Freiburg/Breisgau, , Germany
Georg-August Universität Göttingen
Göttingen, , Germany
Martin-Luther-Universität Halle
Halle, , Germany
Universität Heidelberg
Heidelberg, , Germany
Friedrich-Schiller Universität Jena
Jena, , Germany
Universitätsklinikum Schleswig-Holstein
Kiel, , Germany
Berufsfeuerwehr Kiel
Kiel, , Germany
Universitätsklinikum Mannheim
Mannheim, , Germany
Klinikum rechts der Isar
München, , Germany
Klinikum Saarbrücken gGmbH
Saarbrücken, , Germany
Universitätsklinikum Ulm
Ulm, , Germany
A. O. Ospedali Riuniti di Bergamo
Bergamo, , Italy
Ospedale S. Anna
Como, , Italy
A. O. Universitaria S. Martino
Genova, , Italy
A. O. San Gerardo di Monza
Monza, , Italy
Policlinico S. Matteo
Pavia, , Italy
Osp. di Circolo Fondazione Macchi
Varese, , Italy
ICU, Haukeland Universitetssykehus
Bergen, , Norway
ICU, Sykehuset Østfold Fredrikstad
Fredrikstad, , Norway
Akuttklinikken / NLA, Sentralsjukehuset i Rogaland
Stavanger, , Norway
Pre Hospital Klinikk, Sykehuset i Vestfold Tønsberg
Tønsberg, , Norway
Hospital de Torrecárdenas / ICU
Almería, , Spain
Hospital Clínico Provincial de BCN / Cardiology Service
Barcelona, , Spain
Hospital Universitario Reina Sofía / ICU
Córdoba, , Spain
Vírgen de las Nieves. Critical Care-Emergency Room
Granada, , Spain
Hospital de Jerez de la Frontera / ICU
Jerez de la Frontera, , Spain
Hospital Clínico San Carlos / Hemodynamics
Madrid, , Spain
Hospital Clínico Universitario Vírgen de la Victoria / ICU
Málaga, , Spain
Boehringer Ingelheim Investigational Site
Seville, , Spain
Complejo Hospitalario Universitario de Vigo / Cardiology
Vigo, , Spain
Hospital Clinico Univ. Lozano Blesa
Zaragoza, , Spain
Anestesikliniken
Gävle, , Sweden
Hjärt/Kärlforskn.enheten, Sahlgrenska Univ.sjh. Göteborg
Gothenburg, , Sweden
Universitetssjukhuset
Örebro, , Sweden
Södersjukhuset
Stockholm, , Sweden
Centre interdisciplinaire des urgences (CIU), CHUV BH 06-429
Lausanne, , Switzerland
Boehringer Ingelheim Investigational Site
Lugano, , Switzerland
Countries
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References
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Bottiger BW, Arntz HR, Chamberlain DA, Bluhmki E, Belmans A, Danays T, Carli PA, Adgey JA, Bode C, Wenzel V; TROICA Trial Investigators; European Resuscitation Council Study Group. Thrombolysis during resuscitation for out-of-hospital cardiac arrest. N Engl J Med. 2008 Dec 18;359(25):2651-62. doi: 10.1056/NEJMoa070570.
Other Identifiers
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1123.18
Identifier Type: -
Identifier Source: org_study_id