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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03759210
Other study ID # 2018-01488
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 15, 2018
Est. completion date June 1, 2024

Study information

Verified date July 2023
Source Insel Gruppe AG, University Hospital Bern
Contact Sabine Nabecker, M.D.
Phone +41 31 632 39 65
Email sabine.nabecker@insel.ch
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Sudden cardiac arrests is one of the most frequent causes of death. In Switzerland every year 8000-10.000 people suffer from a cardiac arrest. The EuReCa ONE Study showed regional differences in incidence and chances of survival after cardiac arrests in Europe. The current European Resuscitation Council (ERC) resuscitation guidelines 2015 recommend extracorporeal membrane oxygenation (ECMO) as treatment option for therapy refractory out-of-hospital cardiac arrests (OHCA). ECMO used under cardiopulmonary resuscitation (CPR) is called eCPR (extracorporeal CPR). In the year 2018 eCPR is started to be used in Bern, Switzerland. This study investigates retrospectively the survival and neurologic outcome of patients after OHCA in the region of Bern, Switzerland from 2015-2018. The data will be used as baseline for a prospective evaluation of eCPR cases. The prospective Evaluation of e CPR will last from 2018 - 2022.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date June 1, 2024
Est. primary completion date December 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - All OHCA in the region of Bern, Switzerland in the year 2015-2017 Exclusion Criteria: - if patient has previously declined to be included in a study (advance directive)

Study Design


Locations

Country Name City State
Switzerland Department of Anaesthesiology and Pain Medicine Bern

Sponsors (1)

Lead Sponsor Collaborator
Insel Gruppe AG, University Hospital Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Neurologic Outcome after 30 days CPC 1 - 5 (Cerebral Performance Category Scale) 30 days after OHCA
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