Thrombolysis Using Tenecteplase (Metalyse®) in Cardiac Arrest - The TROICA Trial
A Prospective, Randomised, Double-blind, Placebo-controlled, International, Multicentre, Parallel-group Comparison Trial Evaluating the Efficacy and Safety of Tenecteplase During Cardiopulmonary Resuscitation as Compared With Standard Treatment in Patients Suffering From Out-of-hospital Cardiac Arrest of Presumed Cardiac Origin Thrombolysis in Cardiac Arrest (TROICA) Trial
1 other identifier
interventional
1,050
9 countries
68
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2004
68 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 8, 2005
CompletedFirst Posted
Study publicly available on registry
September 12, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2006
CompletedOctober 29, 2013
October 1, 2013
2.4 years
September 8, 2005
October 28, 2013
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (5)
Return of spontaneous circulation (ROSC)
30 days
24-hr survival
24 hours
Neurological and overall outcome at hospital discharge or at day 30, whichever came first
30 days
Symptomatic intracranial haemorrhage (ICH) up to hospital discharge or day 30, whichever came first
30 days
Major bleeds up to hospital discharge or day 30, whichever came first
30 days
Interventions
Eligibility Criteria
You may qualify if:
- Age at least 18 years (known or estimated; no upper limit)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (68)
Univ.-Klinik f. Anaesthesie Graz
Graz, 8036, Austria
Univ.-Klinik f. Anaesthesie u. Intensivmedizin
Innsbruck, 6020, Austria
LKH Salzburg, St. Johanns-Spital
Salzburg, 5020, Austria
Univ.-Klinik f. Notfallmedizin
Vienna, 1090, Austria
Algemeen Ziekenhuis Antwerpen / Campus Stuivenberg
Antwerp, 2060, Belgium
AZ Sint-Jan AV
Bruges, 8000, Belgium
CHU Saint-Pierre
Brussels, 1000, Belgium
AZ VUB
Brussels, 1090, Belgium
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
AZ Groeningen
Kortrijk, 8500, Belgium
CHU de Tivoli
La Louvière, 7100, Belgium
Universitaire Ziekenhuizen Leuven
Leuven, 3000, Belgium
CHR de la Citadelle
Liège, 4000, Belgium
CHR de Namur
Namur, 5000, Belgium
Hôpital Jean Minjoz
Besançon, 25030, France
Hôpital Avicenne
Bobigny, 93009, France
Hôpital Henri Mondor
Créteil, 94010, France
Hôpital André Mignot
Le Chesnay, 78150, France
Hôpital Régional et Universitaire
Lille, 59037, France
Hôpital Marc Jacquet
Melun, 77011, France
Hôpital Lapeyronie
Montpellier, 34295, France
Hôpital Necker
Paris, 75743, France
Hôpital Charles Nicolle
Rouen, 76031, France
Hôpital Purpan
Toulouse, 31059, France
Hôpital Pierre Bazin
Voiron, 38506, France
Universitätsklinikum Benjamin Franklin
Berlin, 12200, Germany
Humboldt-Klinikum
Berlin, 13504, Germany
DRK Kliniken Westend
Berlin, 14050, Germany
Städtische Kliniken Bielefeld gem. GmbH
Bielefeld, 33604, Germany
Klinikum der Ruhr-Universität Bochum
Bochum, 44791, Germany
Knappschaftskrankenhaus Dortmund
Dortmund, 44309, Germany
Chirurgische Universität Freiburg
Freiburg/Breisgau, 79106, Germany
Georg-August Universität Göttingen
Göttingen, 37075, Germany
Martin-Luther-Universität Halle
Halle, 06120, Germany
Universität Heidelberg
Heidelberg, 69120, Germany
Friedrich-Schiller Universität Jena
Jena, 07740, Germany
Universitätsklinikum Schleswig-Holstein
Kiel, 24105, Germany
Berufsfeuerwehr Kiel
Kiel, 24116, Germany
Universitätsklinikum Mannheim
Mannheim, 68168, Germany
Klinikum rechts der Isar
München, 81675, Germany
Klinikum Saarbrücken gGmbH
Saarbrücken, 66119, Germany
Universitätsklinikum Ulm
Ulm, 89075, Germany
A. O. Ospedali Riuniti di Bergamo
Bergamo, 24100, Italy
Ospedale S. Anna
Como, 22100, Italy
A. O. Universitaria S. Martino
Genova, 16132, Italy
A. O. San Gerardo di Monza
Monza, 20052, Italy
Policlinico S. Matteo
Pavia, 27100, Italy
Osp. di Circolo Fondazione Macchi
Varese, 21100, Italy
ICU, Haukeland Universitetssykehus
Bergen, N-5021, Norway
ICU, Sykehuset Østfold Fredrikstad
Fredrikstad, N-1603, Norway
Akuttklinikken / NLA, Sentralsjukehuset i Rogaland
Stavanger, N-4068, Norway
Pre Hospital Klinikk, Sykehuset i Vestfold Tønsberg
Tønsberg, N-3101, Norway
Hospital de Torrecárdenas / ICU
Almería, 04009, Spain
Hospital Clínico Provincial de BCN / Cardiology Service
Barcelona, 08036, Spain
Hospital Universitario Reina Sofía / ICU
Córdoba, 14004, Spain
Vírgen de las Nieves. Critical Care-Emergency Room
Granada, 18012, Spain
Hospital de Jerez de la Frontera / ICU
Jerez de la Frontera, 11407, Spain
Hospital Clínico San Carlos / Hemodynamics
Madrid, 28040, Spain
Hospital Clínico Universitario Vírgen de la Victoria / ICU
Málaga, 29010, Spain
Boehringer Ingelheim Investigational Site
Seville, 41014, Spain
Complejo Hospitalario Universitario de Vigo / Cardiology
Vigo, 36214, Spain
Hospital Clinico Univ. Lozano Blesa
Zaragoza, 50009, Spain
Anestesikliniken
Gävle, 807 87, Sweden
Hjärt/Kärlforskn.enheten, Sahlgrenska Univ.sjh. Göteborg
Gothenburg, 413 45, Sweden
Universitetssjukhuset
Örebro, 701 85, Sweden
Södersjukhuset
Stockholm, 118 83, Sweden
Centre interdisciplinaire des urgences (CIU), CHUV BH 06-429
Lausanne, 1005, Switzerland
Boehringer Ingelheim Investigational Site
Lugano, 6900, Switzerland
Related Publications (1)
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.
PMID: 19092151DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Boehringer Ingelheim Study Coordinator
B.I. Pharma GmbH & Co. KG
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 8, 2005
First Posted
September 12, 2005
Study Start
January 1, 2004
Primary Completion
June 1, 2006
Study Completion
June 1, 2006
Last Updated
October 29, 2013
Record last verified: 2013-10