I46
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: patients who were treated with the CARL System within the intended use, such as cardiopulmonary resuscitation following a refractory cardiac arrest
Exclusion criteria
Exclusion criteria: Patient has a clearly stated "Do Not Resuscitate" Request Return of sustained spontaneous circulation within 5 minutes of ACLS performed CPR Cardiac arrest due to trauma with hemorrhagic shock Patient has septic shock Patient has known intracranial bleeding Patient has a known acute stroke Patients with a known diagnosis of end-stage cancer. These exclusion criteria are not specific for the CARL system and treatment or the registry study itself, but are derived from the current state-of-the-art in ECLS. They shall contribute to a better clarity of the results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and effectiveness of the CARL System (PMCF Registry Study §23b MPG) Technical effectiveness endpoint: successful function of the CARL system Clinical effectiveness endpoint: overall survival as well as survival with good neurological outcome | — |
Secondary
| Measure | Time frame |
|---|---|
| Achievement of target values (haemodynamic, gas exchange, homeostasis, temperature) Best neurologic Score (CPC) 7-day-survival 30-day-survival and survival with good neurologic outcome parameters of organ function liver, kidney, lunge/ ventilation duration, heart, vascular system treatment duration: CARL; ECLS intensive care unit hospital discharge rehabilitaion | — |
Countries
Austria, Germany
Contacts
Universitäts-Herzzentrum Freiburg-Bad Krozingen, Klinik für Herz- und Gefäßchirurgie