Strategies for Defibrillation During Out-of-Hospital Cardiac Arrest
STRAT-DEFI
1 other identifier
interventional
909
1 country
6
Brief Summary
The "Strategies for Defibrillation during Out-of-Hospital Cardiac Arrest" (STRAT-DEFI) trial is an investigator-initiated, individually randomized, 3-group clinical trial comparing standard anterior-lateral pad positioning with anterior-posterior positioning and double sequential defibrillation during adult out-of-hospital cardiac arrest.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2025
Longer than P75 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 14, 2025
CompletedFirst Posted
Study publicly available on registry
January 17, 2025
CompletedStudy Start
First participant enrolled
March 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2029
May 23, 2025
May 1, 2025
3 years
January 14, 2025
May 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Survival at 30 days
30 days after the cardiac arrest
Secondary Outcomes (3)
Survival at 90 days
90 days after the cardiac arrest
Favorable neurological outcome at 30 days
30 days after the cardiac arrest
Favorable neurological outcome at 90 days
90 days after the cardiac arrest
Study Arms (3)
Anterior-lateral pad positioning
ACTIVE COMPARATORAnterior-posterior pad positioning
EXPERIMENTALDouble-sequential defibrillation
EXPERIMENTALAnterior-lateral pad positioning combined with anterior-posterior pad positioning for a total of 4 pads and 2 shocks.
Interventions
Defibrillation pads positioned anterior-lateral
Defibrillation pads positioned anterior-posterior
Combination of anterior-lateral and anterior-posterior pad positioning for a total of 4 pads and 2 shocks.
Eligibility Criteria
You may qualify if:
- Out-of-hospital cardiac arrest
- Age ≥ 18 years
- ≥ 1 manual defibrillation attempt by emergency medical services
- Shockable rhythm as the last known rhythm
- Two manual defibrillators present on-site
You may not qualify if:
- Blunt trauma, penetrating trauma, or burn injury suspected to be the cause of the cardiac arrest
- Prior enrollment in the trial
- Posterior pad placement not deemed possible by on-site clinician
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lars Wiuff Andersenlead
- University of Aarhuscollaborator
Study Sites (6)
Emergency Medical Services, the North Denmark Region
Aalborg, 9000, Denmark
Danish Air Ambulance, Danish Regions
Aarhus N, 8200, Denmark
Prehospital Emergency Medical Services, Central Denmark Region
Aarhus N, 8200, Denmark
Copenhagen Emergency Medical Services, the Capital Region of Denmark
Ballerup Municipality, 2750, Denmark
The Prehospital Center, Region Zealand
Næstved, 4700, Denmark
Emergency Medical Services, the Region of Southern Denmark
Vejle, 7100, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 14, 2025
First Posted
January 17, 2025
Study Start
March 15, 2025
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
March 1, 2029
Last Updated
May 23, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- After publication of the last results (i.e., 1-year follow-up), all de-identified individual patient data will be made available for data sharing as allowed within Danish law. There will be no predetermined end date for the data sharing.
- Access Criteria
- Data will be available for any research purpose to all interested parties who have approval from an independent review committee if required and who have a methodological sound proposal as determined by the steering committee of the current trial. Only the methodological qualities and not the purpose or objective of the proposal will be considered. Interested parties will be able to request the data by contacting the principal investigator.
De-identified data. All relevant trial-related documents, including the protocol, data dictionary, and the main statistical code, will be shared along with the data.