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NCT Number: NCT06781892

Strategies for Defibrillation During Out-of-Hospital Cardiac Arrest

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.

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Key information

Conditions

Cardiac Arrest (CA) Cardiovascular Diseases Heart Arrest Heart Diseases Out-of-Hospital Cardiac Arrest

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emergency Medical Services, the North Denmark Region, Aalborg, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Anterior-lateral pad positioning

Other

Defibrillation pads positioned anterior-lateral

Anterior-posterior pad positioning

Other

Defibrillation pads positioned anterior-posterior

Double-sequential defibrillation

Other

Combination of anterior-lateral and anterior-posterior pad positioning for a total of 4 pads and 2 shocks.

Primary outcomes

  1. Survival at 30 days

    Time frame: 30 days after the cardiac arrest

Secondary outcomes

  1. Survival at 90 days

    Time frame: 90 days after the cardiac arrest

  2. 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).

  3. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Bertram L Kirkegaard

CONTACT

[email protected]

Lars W Andersen

CONTACT

[email protected]

+4578414848

Sponsors and collaborators

Lead sponsor

Lars Wiuff Andersen

Other

Collaborators

  • University of Aarhus

Registry information

Official study title

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

Acronym: STRAT-DEFI

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Jan 17, 2025
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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