RecruitingNCT04510480SSLUpdated Feb 16, 2022

Systems Saving Lives - Long-term Survival of Out-of-hospital Cardiac Arrest in the Urban Area of Bologna

An observational study in Cardiac Arrest, sponsored by Azienda Usl di Bologna. Recruiting at 1 site in Italy. Open to participants aged Up to 120 Years. Per ClinicalTrials.gov, last updated 2022-02-16.

Sponsored by Azienda Usl di Bologna · Observational

From the registry’s dates

Started Jul 2020; still recruiting 6 years 3 months later.

Study type: Observational
Model: Other
Time perspective: Prospective
Enrollment: 5,000
Ages: Up to 120 Years
Sex: All

Study summary

Evaluation of clinical, logistical, and technical factors (e.g. implementation of pre-arrival instructions, implementation of the DAE RespondER, mechanical chest compressor, REBOA, and E-CPR) that impact on the outcomes of out-of-hospital cardiac arrest patients.

Conditions studied

Cardiac Arrest

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In context

Heart Arrest

966 studies on the registry are indexed under Heart Arrest; 227 are open to participants now.

This study's planned enrollment of 5,000 is above the median of 200 across 383 observational studies indexed under Heart Arrest.

Browse Heart Arrest studies →

Lead sponsor

Azienda Usl di Bologna is the lead sponsor of 40 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Up to 120 Years
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

Population served by EMS of Bologna area

Inclusion criteria

Out of Hospital cardiac arrest patients (historical cohort) from 1st January 2009 and 30th June 2020
Out of Hospital cardiac arrest patients from 1st July 2020 and 31st December 2025

Exclusion criteria

Exclusion Criteria:

False cardiac arrest
In-hospital cardiac arrest

Study design

Observational model: Other
Time perspective: Prospective
Enrollment: 5,000 participants (estimated)
Patient registry: No

Groups and cohorts

cardiac arrest
Out of hospital cardiac arrest patients (Historical cohort) from 1st January 2009 and 30th June 2020. Out of hospital cardiac arrest patients from 1st July 2020 and 31st December 2025.
Other: Observational study without specific intervention

Interventions

OtherObservational study without specific intervention
Observational study with standard cardiac arrest approach

What researchers measure

Primary outcomes

ROSC (Return of spontaneous circulation)
ROSC (Return of spontaneous circulation) of cardiac arrest patients
Time frame: 1st July 2020 to 31st December 2025
Hospital admission status
Hospital admission status of cardiac arrest patients
Time frame: 1st July 2020 to 31st December 2025
Hospital discharge status/survival at 30 days
Hospital discharge status/survival at 30 days of cardiac arrest patients
Time frame: 30 days

Secondary outcomes

Survival at 6 months
Survival at 6 months of cardiac arrest patients
Time frame: 6 months
Survival at 1 years
Survival at 1 years of cardiac arrest patients
Time frame: 1 year

Study locations

1 of 1 sites recruiting

Maggiore Hospital Ospedale Maggiore Carlo Alberto Pizzardi AUSL di Bologna
Bologna, 40110, Italy
- Federico F Semeraro, MD, FERC · Contact · f.semeraro@ausl.bologna.it · +393336592670
- Giovanni Gordini, MD · Contact · g.gordini@118er.it · +0390516478215
- Lorenzo Gamberini, MD · Sub investigator
- Marco Tartaglione, MD · Sub investigator
Recruiting

References and documents

Publications

Grasner JT, Wnent J, Herlitz J, Perkins GD, Lefering R, Tjelmeland I, Koster RW, Masterson S, Rossell-Ortiz F, Maurer H, Bottiger BW, Moertl M, Mols P, Alihodzic H, Hadzibegovic I, Ioannides M, Truhlar A, Wissenberg M, Salo A, Escutnaire J, Nikolaou N, Nagy E, Jonsson BS, Wright P, Semeraro F, Clarens C, Beesems S, Cebula G, Correia VH, Cimpoesu D, Raffay V, Trenkler S, Markota A, Stromsoe A, Burkart R, Booth S, Bossaert L. Survival after out-of-hospital cardiac arrest in Europe - Results of the EuReCa TWO study. Resuscitation. 2020 Mar 1;148:218-226. doi: 10.1016/j.resuscitation.2019.12.042. Epub 2020 Feb 3. PubMed 32027980 ↗
Grasner JT, Lefering R, Koster RW, Masterson S, Bottiger BW, Herlitz J, Wnent J, Tjelmeland IB, Ortiz FR, Maurer H, Baubin M, Mols P, Hadzibegovic I, Ioannides M, Skulec R, Wissenberg M, Salo A, Hubert H, Nikolaou NI, Loczi G, Svavarsdottir H, Semeraro F, Wright PJ, Clarens C, Pijls R, Cebula G, Correia VG, Cimpoesu D, Raffay V, Trenkler S, Markota A, Stromsoe A, Burkart R, Perkins GD, Bossaert LL; EuReCa ONE Collaborators. EuReCa ONE-27 Nations, ONE Europe, ONE Registry: A prospective one month analysis of out-of-hospital cardiac arrest outcomes in 27 countries in Europe. Resuscitation. 2016 Aug;105:188-95. doi: 10.1016/j.resuscitation.2016.06.004. Epub 2016 Jun 16. Erratum In: Resuscitation. 2016 Dec;109:145-146. doi: 10.1016/j.resuscitation.2016.10.001. PubMed 27321577 ↗
Del Giudice D, Semeraro F, Ristagno G, Picoco C, Cordenons F, Dell'Arciprete O, Mora F, Scapigliati A, Gordini G. DAE RespondER: The Emilia Romagna app for a regional "community saving lives" system. Resuscitation. 2019 Dec;145:34-36. doi: 10.1016/j.resuscitation.2019.10.002. Epub 2019 Oct 15. No abstract available. PubMed 31626865 ↗
Oving I, Masterson S, Tjelmeland IBM, Jonsson M, Semeraro F, Ringh M, Truhlar A, Cimpoesu D, Folke F, Beesems SG, Koster RW, Tan HL, Blom MT; ESCAPE-NET Investigators. First-response treatment after out-of-hospital cardiac arrest: a survey of current practices across 29 countries in Europe. Scand J Trauma Resusc Emerg Med. 2019 Dec 16;27(1):112. doi: 10.1186/s13049-019-0689-0. PubMed 31842928 ↗
Di Marco S, Tucci R, Tonelli G, Frione G, Semeraro F, Ristagno G, Scapigliati A. Preparedness for telephone dispatch-assisted cardiopulmonary resuscitation in Italy. A National survey. Resuscitation. 2020 Apr;149:87-88. doi: 10.1016/j.resuscitation.2020.02.007. Epub 2020 Feb 18. No abstract available. PubMed 32084569 ↗
Semeraro F, Gamberini L, Tartaglione M, Mora F, Dell'Arciprete O, Cordenons F, Del Giudice D, Picoco C, Gordini G. An integrated response to the impact of coronavirus outbreak on the Emergency Medical Services of Emilia Romagna. Resuscitation. 2020 Jun;151:1-2. doi: 10.1016/j.resuscitation.2020.03.005. Epub 2020 Mar 20. No abstract available. PubMed 32205158 ↗
Scquizzato T, Burkart R, Greif R, Monsieurs KG, Ristagno G, Scapigliati A, Semeraro F. Mobile phone systems to alert citizens as first responders and to locate automated external defibrillators: A European survey. Resuscitation. 2020 Jun;151:39-42. doi: 10.1016/j.resuscitation.2020.03.009. Epub 2020 Apr 3. No abstract available. PubMed 32251700 ↗
Nolan JP, Monsieurs KG, Bossaert L, Bottiger BW, Greif R, Lott C, Madar J, Olasveengen TM, Roehr CC, Semeraro F, Soar J, Van de Voorde P, Zideman DA, Perkins GD; European Resuscitation Council COVID-Guideline Writing Groups. European Resuscitation Council COVID-19 guidelines executive summary. Resuscitation. 2020 Aug;153:45-55. doi: 10.1016/j.resuscitation.2020.06.001. Epub 2020 Jun 7. PubMed 32525022 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 16, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04510480
Lead sponsor: Azienda Usl di Bologna
Responsible party: Sponsor
First posted: Aug 12, 2020
Start date: Jul 1, 2020
Primary completion: Jul 1, 2021
Completion: Dec 31, 2025 (estimated)
Last update: Feb 16, 2022

Study contacts

Federico F Semeraro, MD, FERC

Contact

f.semeraro@ausl.bologna.it

+393336592670

Federico F Semeraro, MD, FERC

principal investigator · Maggiore Hospital Carlo Alberto Pizzardi AUSL di Bologna

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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