Thrombolysis Using Tenecteplase (Metalyse®) in Cardiac Arrest - The TROICA Trial

• Status: Terminated
• Trial end date: 2006-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Tenecteplase; Tissue Plasminogen Activator

Criteria

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