Controlled Automated Reperfusion of the Whole Body (CARL) PMCF Registry Study

Recruiting

Conditions: I46
Cardiac arrest

Registration Number: DRKS00018967

Lead Sponsor: Firma Resuscitec GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 100

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

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.

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety and effectiveness of the CARL System (PMCF Registry Study §23b MPG)<br><br>Technical effectiveness endpoint: successful function of the CARL system<br><br>Clinical effectiveness endpoint: overall survival as well as survival with good neurological outcome

Secondary Outcome Measures

Name	Time	Method
Achievement of target values (haemodynamic, gas exchange, homeostasis, temperature)<br><br>Best neurologic Score (CPC)<br>7-day-survival<br><br>30-day-survival and survival with good neurologic outcome<br><br>parameters of organ function<br>liver, kidney, lunge/ ventilation duration, heart, vascular system <br><br>treatment duration:<br>CARL; ECLS<br>intensive care unit<br>hospital discharge<br>rehabilitaion