Cardiac Arrest (CA)STRAT-DEFINCT06781892
Strategies for Defibrillation During Out-of-Hospital Cardiac Arrest
A study testing Anterior-lateral pad positioning, Anterior-posterior pad positioning and Double-sequential defibrillation in people with Cardiac Arrest (CA), run by Lars Wiuff Andersen at 6 sites in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest (CA)
- What is being tested?
- Anterior-lateral pad positioning, Anterior-posterior pad positioning and Double-sequential defibrillation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 909 participants
- Where
- 6 sitesDenmark
- Study dates
- 15 Mar 2025to 1 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Bertram L Kirkegaard contact
6 sites in 1 country
Denmark6 sites, 6 recruiting
- Recruiting
Emergency Medical Services, the North Denmark Region
Aalborg, 9000
Thomas L Klitgaard, +4597662100, tlk@rn.dk
- Not yet recruiting
Danish Air Ambulance, Danish Regions
Aarhus N, 8200
Jacob Steinmetz, +4578414936, jacob.steinmetz@regionh.dk
- Recruiting
Prehospital Emergency Medical Services, Central Denmark Region
Aarhus N, 8200
Bertram L Kirkegaard, +4578414848, bertramkirkegaard@clin.au.dk
- Not yet recruiting
Copenhagen Emergency Medical Services, the Capital Region of Denmark
Ballerup Municipality, 2750
Fredrik Folke, +4538665000, fredrik.folke@regionh.dk
- Not yet recruiting
The Prehospital Center, Region Zealand
Næstved, 4700
Helle C Christensen, +4557684100, hcli@regionsjaelland.dk
- Not yet recruiting
Emergency Medical Services, the Region of Southern Denmark
Vejle, 7100
Søren Mikkelsen, +4576631000, soeren.mikkelsen@rsyd.dk
About this study
Official title: 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.
- Conditions
- Cardiac Arrest (CA)
- Being tested
- Anterior-lateral pad positioning, Anterior-posterior pad positioning, Double-sequential defibrillation
- Keywords
- Out-of-hospital cardiac arrest, Defibrillation, Double-sequential defibrillation
- Medical subject headings
- Heart Arrest, Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior-lateral pad positioningOther
Defibrillation pads positioned anterior-lateral
Anterior-posterior pad positioningOther
Defibrillation pads positioned anterior-posterior
Double-sequential defibrillationOther
Combination of anterior-lateral and anterior-posterior pad positioning for a total of 4 pads and 2 shocks.
| Study group | Role | What they receive |
|---|---|---|
| Anterior-lateral pad positioning | Active comparator | Not described Receives: Other: Anterior-lateral pad positioning |
| Anterior-posterior pad positioning | Experimental | Not described Receives: Other: Anterior-posterior pad positioning |
| Double-sequential defibrillation | Experimental | Anterior-lateral pad positioning combined with anterior-posterior pad positioning for a total of 4 pads and 2 shocks. Receives: Other: Double-sequential defibrillation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival at 30 days
Measured: 30 days after the cardiac arrest
Secondary outcomes (3)
Survival at 90 days
Measured: 90 days after the cardiac arrest
Favorable neurological outcome at 30 days
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).
Measured: 30 days after the cardiac arrest
Favorable neurological outcome at 90 days
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).
Measured: 90 days after the cardiac arrest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start15 Mar 2025
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac Arrest (CA)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 909 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lars Wiuff Andersen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus
- Responsible party
- Sponsor-investigator, Lars Wiuff Andersen, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06781892
- Sponsor's protocol ID
- 00006
- Acronym
- STRAT-DEFI
- Status last verified
- May 2025
- First submitted
- 14 Jan 2025
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Kirkegaard BL, Vallentin MF, Meilandt C, Terkelsen CJ, Bach A, Winther KB, Mikkelsen S, Christensen HC, Christensen S, Dissing T, Klitgaard TL, Folke F, Steinmetz J, Skrifvars MB, Genbrugge C, Masterson S, Hoikka M, Granfeldt A, Andersen LW. Strategies for defibrillation during out-of-hospital cardiac arrest - protocol for a randomised clinical trial. Resusc Plus. 2026 Oct 6;32:101512. doi: 10.1016/j.resplu.2026.101512. eCollection 2026 Nov.
PubMed 42935832
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategies for Defibrillation During Out-of-Hospital Cardiac Arrest - A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06781892
- Acronym / sponsor ID
- STRAT-DEFI / 00006
- Conditions
- Cardiac Arrest (CA)
- Keywords
- Out-of-hospital cardiac arrest, Defibrillation, Double-sequential defibrillation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 909 participants (estimated)
- Lead sponsor
- Lars Wiuff AndersenUniversity, hospital or other
- Collaborators
- University of Aarhus
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 17 Jan 2025 (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 "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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anterior-lateral pad positioning | Active comparator | Other: Anterior-lateral pad positioning |
| Anterior-posterior pad positioning | Experimental | Other: Anterior-posterior pad positioning |
| Double-sequential defibrillation | Experimental | Other: Double-sequential defibrillationAnterior-lateral pad positioning combined with anterior-posterior pad positioning for a total of 4 pads and 2 shocks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Anterior-lateral pad positioningDefibrillation pads positioned anterior-lateral | Other | Anterior-lateral pad positioning |
| Anterior-posterior pad positioningDefibrillation pads positioned anterior-posterior | Other | Anterior-posterior pad positioning |
| Double-sequential defibrillationCombination of anterior-lateral and anterior-posterior pad positioning for a total of 4 pads and 2 shocks. | Other | Double-sequential defibrillation |
Primary outcome
Survival at 30 days
Time frame: 30 days after the cardiac arrest
3 secondary outcomes
Survival at 90 days
Time frame: 90 days after the cardiac arrest
Favorable neurological outcome at 30 days
Time frame: 30 days after the cardiac arrest
Favorable neurological outcome at 90 days
Time frame: 90 days after the cardiac arrest
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Derived from this study: PubMed 42935832Kirkegaard BL, Vallentin MF, Meilandt C, Terkelsen CJ, Bach A, Winther KB, Mikkelsen S, Christensen HC, Christensen S, Dissing T, Klitgaard TL, Folke F, Steinmetz J, Skrifvars MB, Genbrugge C, Masterson S, Hoikka M, Granfeldt A, Andersen LW. Strategies for defibrillation during out-of-hospital cardiac arrest - protocol for a randomised clinical trial. Resusc Plus. 2026 Oct 6;32:101512. doi: 10.1016/j.resplu.2026.101512. eCollection 2026 Nov.
- Individual participant dataSharing planned: Yes. 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.
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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.
Bertram L Kirkegaard contact
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anterior-lateral pad positioning, Anterior-posterior pad positioning and Double-sequential defibrillation in people with Cardiac Arrest (CA), run by Lars Wiuff Andersen at 6 sites in Denmark.
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 5 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lars W Andersen (+4578414848, lwandersen@clin.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival at 30 days (time frame: 30 days after the cardiac arrest). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06781892, which also lists 1 linked publication.
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 23 May 2025.