Sex-unique Disparities in Survival and Resuscitation Afte... | NCT05583084

Studies
Sex-unique Disparities in Survival and Resuscitation After Out-of-hospital Cardiac Arrest - a Danish Analysis

NCT05583084

Sponsor

Prehospital Center, Region Zealand

Status

Completed

Last Update Posted

Oct 17, 2022Actual

Enrollment

27,000Actual

Phase

Not provided

Conditions

Out-Of-Hospital Cardiac Arrest

Interventions

Investigation

Countries

Not provided

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

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2016Actual

Primary Completion Date

Dec 31, 2021Actual

Completion Date

Dec 31, 2021Actual

First Submitted Date

Oct 5, 2022

First Submission Date that Met QC Criteria

Oct 13, 2022

First Posted Date

Oct 17, 2022Actual

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

Oct 13, 2022

Last Update Posted Date

Oct 17, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Eleonora Casarini, Fellow researcher and medical student, Prehospital Center, Region ZealandPrincipal Investigator

Lead Sponsor

Prehospital Center, Region ZealandOTHER

Collaborators

Not provided

Description Module

Brief 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 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.

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

27,000Actual

Name	Type	Description	Arm Group Labels	Other Names
Investigation	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
30-days survival	Records on survival after 30 days from cardiac arrest	30 days from OHCA

Secondary Outcomes

Measure	Description	Time Frame
Cardiopulmonary Resuscitation (CPR)	Whether or not CPR was performed on the patient	2016-2021
Presence of shockable initial rhythm (SIR)	Whether or not a schockable intial rhythm was recorded

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- All emergency medical services treated resuscitations in Denmark between 2016 and 2021

Exclusion Criteria:

- Patients that are found dead at emergency medical service arrival, with sure death indicators such as rigor mortis or livores.

Accepts Healthy Volunteers

Not provided

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 emergency medical services treated resuscitations in Denmark between 2016 and 2021 registered in the national electronic based Danish OHCA registry

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 5, 2022	Oct 5, 2022	Prot_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D058687	Out-of-Hospital Cardiac Arrest

Ancestor Terms

ID	Term
D006323	Heart Arrest
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016358	Contact Tracing

Ancestor Terms

ID	Term
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D011634	Public Health
D004778	Environment and Public Health

Browse Leaves

Not provided

Browse Branches

Not provided