Cardiac ArrestSSLNCT04510480
Systems Saving Lives - Long-term Survival of Out-of-hospital Cardiac Arrest in the Urban Area of Bologna
An observational study of Cardiac Arrest, run by Azienda Usl di Bologna at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 120 years
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- Observational study without specific intervention
- How many people
- 5,000 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2020to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Population served by EMS of Bologna area
Who may be able to join
- 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
Who cannot join
- False cardiac arrest
- In-hospital cardiac arrest
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Maggiore Hospital Ospedale Maggiore Carlo Alberto Pizzardi AUSL di Bologna
Bologna, 40110
Federico F Semeraro, MD, FERC, +393336592670, f.semeraro@ausl.bologna.it
Giovanni Gordini, MD, +0390516478215, g.gordini@118er.it
About this study
Official title: Systems Saving Lives - Long-term Survival of Out-of-hospital Cardiac Arrest in the Urban Area of Bologna Following the Implementation of the Pre-arrival Instructions, the DAE RespondER, Mechanical Chest Compressors and Circulatory Support With REBOA and ECMO
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
- Cardiac Arrest
- Being tested
- Observational study without specific intervention
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational study without specific interventionOther
Observational study with standard cardiac arrest approach
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Observational study without specific intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
ROSC (Return of spontaneous circulation)
ROSC (Return of spontaneous circulation) of cardiac arrest patients
Measured: 1st July 2020 to 31st December 2025
Hospital admission status
Hospital admission status of cardiac arrest patients
Measured: 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
Measured: 30 days
Secondary outcomes (2)
Survival at 6 months
Survival at 6 months of cardiac arrest patients
Measured: 6 months
Survival at 1 years
Survival at 1 years of cardiac arrest patients
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start1 Jul 2020
- Primary completion1 Jul 2021
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Usl di Bologna
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Federico F Semeraro, MD, FERC, Principal investigator, Maggiore Hospital Carlo Alberto Pizzardi AUSL di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04510480
- Sponsor's protocol ID
- 1.0
- Acronym
- SSL
- Status last verified
- Feb 2022
- First submitted
- 9 Jul 2020
- Last updated
- 16 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 32027980Grasner 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.
PubMed 27321577Del 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 31626865Oving 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 31842928Di 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 32084569Semeraro 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 32205158Scquizzato 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 32251700Nolan 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systems Saving Lives - Long-term Survival of Out-of-hospital Cardiac Arrest in the Urban Area of Bologna Following the Implementation of the Pre-arrival Instructions, the DAE RespondER, Mechanical Chest Compressors and Circulatory Support With REBOA and ECMO
- ClinicalTrials.gov ID
- NCT04510480
- Acronym / sponsor ID
- SSL / 1.0
- Conditions
- Cardiac Arrest
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Azienda Usl di BolognaOther government
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 12 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cardiac arrest | – | Other: Observational study without specific interventionOut 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. |
Who may qualify
- Ages
- Up to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Population served by EMS of Bologna area
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- False cardiac arrest
- In-hospital cardiac arrest
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational study without specific interventionObservational study with standard cardiac arrest approach | Other | cardiac arrest |
Primary outcome
ROSC (Return of spontaneous circulation)
Time frame: 1st July 2020 to 31st December 2025
ROSC (Return of spontaneous circulation) of cardiac arrest patients
Hospital admission status
Time frame: 1st July 2020 to 31st December 2025
Hospital admission status of cardiac arrest patients
Hospital discharge status/survival at 30 days
Time frame: 30 days
Hospital discharge status/survival at 30 days of cardiac arrest patients
2 secondary outcomes
Survival at 6 months
Time frame: 6 months
Survival at 1 years
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
- Results publication: PubMed 32027980Grasner 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.
- Results publication: PubMed 27321577Grasner 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.
- Results publication: PubMed 31626865Del 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.
- Results publication: PubMed 31842928Oving 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.
- Results publication: PubMed 32084569Di 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.
- Results publication: PubMed 32205158Semeraro 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.
- Results publication: PubMed 32251700Scquizzato 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.
- Results publication: PubMed 32525022Nolan 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.
- EMS regional websiteLink provided by the sponsor.
- DAE RespondER websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Federico F Semeraro, MD, FERC principal investigator
Maggiore Hospital Carlo Alberto Pizzardi AUSL di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest, run by Azienda Usl di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Federico F Semeraro, MD, FERC (+393336592670, f.semeraro@ausl.bologna.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ROSC (Return of spontaneous circulation) (time frame: 1st July 2020 to 31st December 2025). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04510480, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2022.