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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00018967
Enrollment
100
Registered
2019-10-31
Start date
2020-02-17
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I46

Interventions

Group 1: Patients in cardiac arrest undergoing treatment with the CARL System (Fa. Resuscitec GmbH, Freiburg, Deutschland)

Sponsors

Firma Resuscitec GmbH
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime 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

MeasureTime 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

Public ContactGeorg Trummer

Universitäts-Herzzentrum Freiburg-Bad Krozingen, Klinik für Herz- und Gefäßchirurgie

georg.trummer@uniklinik-freiburg.de+49 761 270 24400

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026