Status:
TERMINATED
Thrombolysis Using Tenecteplase (Metalyse®) in Cardiac Arrest - The TROICA Trial
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Heart Arrest
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 pa...
Eligibility Criteria
Inclusion
- Patients, indicated for pre-hospital ALS-CPR procedures\* must fulfil the following inclusion criteria:
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
End Date :
June 1 2006
Estimated Enrollment :
1050 Patients enrolled
Trial Details
Trial ID
NCT00157261
Start Date
January 1 2004
End Date
June 1 2006
Last Update
October 29 2013
Active Locations (68)
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1
Univ.-Klinik f. Anaesthesie Graz
Graz, Austria, 8036
2
Univ.-Klinik f. Anaesthesie u. Intensivmedizin
Innsbruck, Austria, 6020
3
LKH Salzburg, St. Johanns-Spital
Salzburg, Austria, 5020
4
Univ.-Klinik f. Notfallmedizin
Vienna, Austria, 1090