Out-Of-Hospital Cardiac ArrestNCT05583084
Sex-unique Disparities in Survival and Resuscitation After Out-of-hospital Cardiac Arrest - a Danish Analysis
An observational study of Out-Of-Hospital Cardiac Arrest, run by Prehospital Center, Region Zealand.
Trial summary
The goal of this observational study is to investigate characteristics in out-of-hospital cardiac arrests (OHCA) related to sex differences. The main questions it aims to answer are: are there possible differences in help provision by bystanders, cardiopulmonary resuscitation (CPR), pre-hospital treatment by emergency… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Out-Of-Hospital Cardiac Arrest
- What is being tested?
- Investigation
- How many people
- 27,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 31 Dec 2021
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: All emergency medical services treated resuscitations in Denmark between 2016 and 2021 registered in the national electronic based Danish OHCA registry
Who may be able to join
- All emergency medical services treated resuscitations in Denmark between 2016 and 2021
Who cannot join
- Patients that are found dead at emergency medical service arrival, with sure death indicators such as rigor mortis or livores.
About this study
The goal of this observational study is to investigate characteristics in out-of-hospital cardiac arrests (OHCA) related to sex differences.
The main questions it aims to answer are:
- are there possible differences in help provision by bystanders, cardiopulmonary resuscitation (CPR), pre-hospital treatment by emergency medical services (EMS)?
- are there differences in the presence of shockable initial rhythm (SIR) and survival rates after OHCA at successive stages of treatment? Researchers will compare all emergency medical services treated resuscitations in Denmark between 2016 and 2021 to see if there are possible differences between sexes.
Read the detailed description
This analysis will be based on data from the national electronic based Danish OHCA registry. Data on OHCAs with resuscitative attempts in Denmark have been collected in the electronic based Danish Medical Service report system since 2016. The registry covers detailed data including the EMS report, executive entries, and advanced text searches of prehospital charts. All cases go through an elaborate validation process where all identified events are read through manually by an external verification team. This ensures high quality of data, collected according to the Utstein recommendations, throughout the approximately 5400 cases of OHCA in Denmark annually. During this verification process, supplementary sources of data are linked to each OHCA, among others information about survival, localization, initiation of bystander CPR and EMS personnel operation.
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Being tested
- Investigation
- Keywords
- sex differences, ohca, women, SIR, CPR
- Medical subject headings
- Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InvestigationOther
What is being measured
The primary outcome is the main question the study is designed to answer.
30-days survival
Records on survival after 30 days from cardiac arrest
Measured: 30 days from OHCA
Secondary outcomes (3)
Cardiopulmonary Resuscitation (CPR)
Whether or not CPR was performed on the patient
Measured: 2016-2021
Presence of shockable initial rhythm (SIR)
Whether or not a schockable intial rhythm was recorded
Measured: 2016-2021
Return of spontaneous circulation (ROSC) at any time
Whether or not there was return of spontaneous circulation at any time
Measured: 2016-2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start1 Jan 2016
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Out-Of-Hospital 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 27,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prehospital Center, Region Zealand
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eleonora Casarini, Prehospital Center, Region Zealand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05583084
- Sponsor's protocol ID
- ohcagd2022
- Status last verified
- Oct 2022
- First submitted
- 5 Oct 2022
- Last updated
- 17 Oct 2022
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sex-unique Disparities in Survival and Resuscitation After Out-of-hospital Cardiac Arrest - a Danish Analysis
- ClinicalTrials.gov ID
- NCT05583084
- Acronym / sponsor ID
- ohcagd2022
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Keywords
- sex differences, ohca, women, SIR, CPR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27,000 participants (actual)
- Lead sponsor
- Prehospital Center, Region ZealandUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 17 Oct 2022 (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.
The goal of this observational study is to investigate characteristics in out-of-hospital cardiac arrests (OHCA) related to sex differences.
The main questions it aims to answer are:
- are there possible differences in help provision by bystanders, cardiopulmonary resuscitation (CPR), pre-hospital treatment by emergency medical services (EMS)?
- are there differences in the presence of shockable initial rhythm (SIR) and survival rates after OHCA at successive stages of treatment? Researchers will compare all emergency medical services treated resuscitations in Denmark between 2016 and 2021 to see if there are possible differences between sexes.
Detailed description
This analysis will be based on data from the national electronic based Danish OHCA registry. Data on OHCAs with resuscitative attempts in Denmark have been collected in the electronic based Danish Medical Service report system since 2016. The registry covers detailed data including the EMS report, executive entries, and advanced text searches of prehospital charts. All cases go through an elaborate validation process where all identified events are read through manually by an external verification team. This ensures high quality of data, collected according to the Utstein recommendations, throughout the approximately 5400 cases of OHCA in Denmark annually. During this verification process, supplementary sources of data are linked to each OHCA, among others information about survival, localization, initiation of bystander CPR and EMS personnel operation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All emergency medical services treated resuscitations in Denmark between 2016 and 2021 registered in the national electronic based Danish OHCA registry
Key inclusion criteria (1 listed)
- All emergency medical services treated resuscitations in Denmark between 2016 and 2021
Key exclusion criteria (1 listed)
- Patients that are found dead at emergency medical service arrival, with sure death indicators such as rigor mortis or livores.
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 |
|---|---|---|
| Investigation | Other | – |
Primary outcome
30-days survival
Time frame: 30 days from OHCA
Records on survival after 30 days from cardiac arrest
3 secondary outcomes
Cardiopulmonary Resuscitation (CPR)
Time frame: 2016-2021
Presence of shockable initial rhythm (SIR)
Time frame: 2016-2021
Return of spontaneous circulation (ROSC) at any time
Time frame: 2016-2021
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2022.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Out-Of-Hospital Cardiac Arrest, run by Prehospital Center, Region Zealand.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 17 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-days survival (time frame: 30 days from OHCA). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Oct 2022.