Strategies for Defibrillation During Out-of-Hospital Cardiac Arrest (STRAT-DEFI)

May 22, 2025 updated by: Lars Wiuff Andersen

Strategies for Defibrillation During Out-of-Hospital Cardiac Arrest - A Randomized Clinical Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

909

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
      • Aalborg, Denmark, 9000
        • Recruiting
        • Emergency Medical Services, the North Denmark Region
        • Contact:
          • Thomas L Klitgaard
          • Phone Number: +4597662100
          • Email: tlk@rn.dk
      • Aarhus N, Denmark, 8200
        • Recruiting
        • Prehospital Emergency Medical Services, Central Denmark Region
        • Contact:
      • Aarhus N, Denmark, 8200
        • Not yet recruiting
        • Danish Air Ambulance, Danish Regions
        • Contact:
      • Ballerup, Denmark, 2750
        • Not yet recruiting
        • Copenhagen Emergency Medical Services, the Capital Region of Denmark
        • Contact:
      • Næstved, Denmark, 4700
        • Not yet recruiting
        • The Prehospital Center, Region Zealand
        • Contact:
      • Vejle, Denmark, 7100
        • Not yet recruiting
        • Emergency Medical Services, the Region of Southern Denmark
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Out-of-hospital cardiac arrest
  2. Age ≥ 18 years
  3. ≥ 1 manual defibrillation attempt by emergency medical services
  4. Shockable rhythm as the last known rhythm
  5. Two manual defibrillators present on-site

Exclusion Criteria:

  1. Blunt trauma, penetrating trauma, or burn injury suspected to be the cause of the cardiac arrest
  2. Prior enrollment in the trial
  3. Posterior pad placement not deemed possible by on-site clinician

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Anterior-lateral pad positioning
Other: Anterior-lateral pad positioning
Defibrillation pads positioned anterior-lateral
Experimental: Anterior-posterior pad positioning
Other: Anterior-posterior pad positioning
Defibrillation pads positioned anterior-posterior
Experimental: Double-sequential defibrillation
Anterior-lateral pad positioning combined with anterior-posterior pad positioning for a total of 4 pads and 2 shocks.
Other: Double-sequential defibrillation
Combination of anterior-lateral and anterior-posterior pad positioning for a total of 4 pads and 2 shocks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival at 30 days
Time Frame: 30 days after the cardiac arrest
30 days after the cardiac arrest

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival at 90 days
Time Frame: 90 days after the cardiac arrest
90 days after the cardiac arrest
Favorable neurological outcome at 30 days
Time Frame: 30 days after the cardiac arrest
Neurological outcome will be assessed with the modified Rankin Scale (mRS) which is a scale from 0 to 6 assessing neurological/functional outcomes after brain damage with higher scores indicating worse neurological/functional outcomes. The scale will will be dichotomized as favorable (mRS 0-3) vs. unfavorable (mRS 4-6).
30 days after the cardiac arrest
Favorable neurological outcome at 90 days
Time Frame: 90 days after the cardiac arrest
Neurological outcome will be assessed with the modified Rankin Scale (mRS) which is a scale from 0 to 6 assessing neurological/functional outcomes after brain damage with higher scores indicating worse neurological/functional outcomes. The scale will will be dichotomized as favorable (mRS 0-3) vs. unfavorable (mRS 4-6).
90 days after the cardiac arrest

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lars Wiuff Andersen

Collaborators

University of Aarhus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2025

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2029

Study Registration Dates

First Submitted

January 14, 2025

First Submitted That Met QC Criteria

January 14, 2025

First Posted (Actual)

January 17, 2025

Study Record Updates

Last Update Posted (Actual)

May 23, 2025

Last Update Submitted That Met QC Criteria

May 22, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiac Arrest (CA)

Clinical Trials on Anterior-lateral pad positioning

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe