Hyperinvasive Approach in Cardiac Arrest (NCT01511666) | Clinical Trial Compass
TerminatedNot Applicable
Hyperinvasive Approach in Cardiac Arrest
Stopped: DSMB recommendation to stop
Czechia256 participantsStarted 2013-03
Plain-language summary
Prague out-of Hospital Cardiac Arrest (OHCA) study is a prospective randomized multicenter clinical study comparing use of prehospital intraarrest hypothermia, mechanical chest compression device, extracorporeal life support (ECLS) and early invasive investigation and treatment (coronary angiography/percutaneous coronary intervention \[PCI\]; pulmonary angiography/percutaneous embolectomy; aortography) in all patients with OHCA of presumed cardiac origin compared to standard of care. It is hypothesized, that above stated "hyperinvasive" approach might improve outcome of out-of hospital cardiac arrest victims.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* minimum of 18 and maximum of 65 years
* witnessed out-of-hospital cardiac arrest of presumed cardiac cause
* minimum of 5 minutes of ACLS performed by emergency medical service team without sustained ROSC
* unconsciousness (Glasgow Coma Score \< 8)
* ECMO team and bed-capacity in cardiac center available.
Exclusion Criteria:
* OHCA of presumed non-cardiac cause
* unwitnessed collapse
* pregnancy
* sustained ROSC within 5 minutes of ACLS performed by EMS team
* conscious patient
* known bleeding diathesis or suspected or confirmed acute or recent intracranial bleeding
* suspected or confirmed acute stroke
* known severe chronic organ dysfunction or other limitations in therapy
* "do not resuscitate" order or other circumstances making 180 day survival unlikely
* known pre-arrest cerebral performance category CPC ≥ 3.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Composite endpoint of survival with good neurological outcome (CPC 1-2).