Outcome After Out of Hospital Cardiac Arrest in Bern, Swi... | NCT03759210

Studies
Outcome After Out of Hospital Cardiac Arrest in Bern, Switzerland

NCT03759210

Sponsor

Insel Gruppe AG, University Hospital Bern

Status

Unknown status

Last Update Posted

Jul 19, 2023Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Resuscitation
Outcome, Fatal
Out-Of-Hospital Cardiac Arrest

Interventions

Not provided

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 15, 2018Actual

Primary Completion Date

Dec 30, 2023Estimated

Completion Date

Jun 1, 2024Estimated

First Submitted Date

Nov 28, 2018

First Submission Date that Met QC Criteria

Nov 28, 2018

First Posted Date

Nov 29, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 18, 2023

Last Update Posted Date

Jul 19, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Neurologic Outcome after 30 days	CPC 1 - 5 (Cerebral Performance Category Scale)	30 days after OHCA

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All OHCA cases in the region of Bern, Switzerland in the year 2015-2017

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sabine Nabecker, M.D.	Contact	+41 31 632 39 65		sabine.nabecker@insel.ch

Overall Officials

Name	Affiliation	Role
Robert Greif, Prof., M.D.	University Hospital Bern, Bern, Switzerland	Study Chair
Sabine Nabecker, M.D.	University Hospital Bern, Bern, Switzerland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anaesthesiology and Pain Medicine	Recruiting	Bern			Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41551516	Derived	Ebert F, Abt M, Fehr T, Seidl K, Huber M, Ludwig R, Iten M, Greif R, Nabecker S, Fuchs A. Long-term neurological outcome following out-of-hospital cardiac arrest in Switzerland: a single-centre observational study. Front Med (Lausanne). 2026 Jan 2;12:1716369. doi: 10.3389/fmed.2025.1716369. eCollection 2025.

ID	Term
D006323	Heart Arrest
D006331	Heart Diseases
D002318	Cardiovascular Diseases