About this trial
This study will test if a sustained Return of Spontaneous Circulation (ROSC) in patients with cardiac arrest is more frequent when patients receive advanced cardiac life support (ACLS) alone or when they receive ACLS plus a balloon occlusion of the thoracic aorta.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
patients suffering from in hospital cardiac arrest (IHCA), including patients with out of hospital cardiac arrest (OHCA) and return of spontaneous circulation (ROSC), transported to the emergency department, where they suffer a second arrest (IHCA)
successful placement of a femoral artery introducer sheath
any electrical cardiac activity seen in the initial rhythm analysis
ongoing effort of resuscitation as determined by study-independent resuscitation lead
Disqualifiers
IHCA in the operating room, on intensive care unit or in the cardiac catheter laboratory
hospital visitors suffering from cardiac arrest
asystole seen in the initial rhythm analysis
(presumed) age under 18 years
Trial design
Parallel
Treatments tested in this trial
resuscitative endovascular occlusion of the aorta (REBOA)
DeviceInsertion of a balloon catheter through the common femoral artery, retrograde advancement of the catheter into the descending thoracic aorta, ballon occlusion of the aorta
Advanced Cardiac Life Support (ACLS)
Other interventionAdvanced Cardiac Life Support (ACLS) as per American Heart Association (AHA) or European Resuscitation Council (ERC) standards
Treatment groups
Trial outcomes
Primary outcomes
Sustained ROSC
Any return of spontaneous circulation lasting longer then 20 minutes
Secondary outcomes
Survival to hospital discharge
dead or alive
Survival to six month
dead or alive
neurologic outcome at the time of 30 days
measured by means of modified ranking scale
neurologic outcome at the time of six month
measured by means of modified ranking scale
Other outcomes
non-invasive cerebral oxygenation during resuscitation
Exploratory, measured in %
cause of death
exploratory, written description
Troponin T trajectory
exploratory
Neuron-Specific Enolase (NSE) trajectory
exploratory
Sponsors and contacts
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