NCT04510480

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

July 9, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 12, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

February 16, 2022

Status Verified

February 1, 2022

Enrollment Period

1 year

First QC Date

July 9, 2020

Last Update Submit

February 15, 2022

Conditions

Cardiac Arrest

Outcome Measures

Primary Outcomes (3)

  • ROSC (Return of spontaneous circulation)

    ROSC (Return of spontaneous circulation) of cardiac arrest patients

    1st July 2020 to 31st December 2025

  • Hospital admission status

    Hospital admission status of cardiac arrest patients

    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

    30 days

Secondary Outcomes (2)

  • Survival at 6 months

    6 months

  • Survival at 1 years

    1 year

Study Arms (1)

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

Observational study without specific interventionOTHER

Observational study with standard cardiac arrest approach

cardiac arrest

Eligibility Criteria

AgeUp to 120 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Population served by EMS of Bologna area

You may qualify if:

  • 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

You may not qualify if:

  • False cardiac arrest
  • In-hospital cardiac arrest

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maggiore Hospital Ospedale Maggiore Carlo Alberto Pizzardi AUSL di Bologna

Bologna, 40110, Italy

RECRUITING

Related Publications (8)

  • 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.

    PMID: 32027980RESULT

  • 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.

    PMID: 27321577RESULT

  • 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.

    PMID: 31626865RESULT

  • 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.

    PMID: 31842928RESULT

  • 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.

    PMID: 32084569RESULT

  • 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.

    PMID: 32205158RESULT

  • 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.

    PMID: 32251700RESULT

  • 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.

    PMID: 32525022RESULT

Related Links

MeSH Terms

Conditions

Heart Arrest

Interventions

Observation

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Federico F Semeraro, MD, FERC

    Maggiore Hospital Carlo Alberto Pizzardi AUSL di Bologna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Federico F Semeraro, MD, FERC

CONTACT

+393336592670f.semeraro@ausl.bologna.it

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2020

First Posted

August 12, 2020

Study Start

July 1, 2020

Primary Completion

July 1, 2021

Study Completion

December 31, 2025

Last Updated

February 16, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)