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| Name | Class |
|---|---|
| University of Aarhus | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anterior-lateral pad positioning | Active Comparator |
| |
| Anterior-posterior pad positioning | Experimental |
| |
| Double-sequential defibrillation | Experimental | Anterior-lateral pad positioning combined with anterior-posterior pad positioning for a total of 4 pads and 2 shocks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anterior-lateral pad positioning | Other | Defibrillation pads positioned anterior-lateral |
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| Measure | Description | Time Frame |
|---|---|---|
| Survival at 30 days | 30 days after the cardiac arrest |
| Measure | Description | Time Frame |
|---|---|---|
| Survival at 90 days | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lars W Andersen | Contact | +4578414848 | lwandersen@clin.au.dk | |
| Bertram L Kirkegaard | Contact | bertramkirkegaard@clin.au.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emergency Medical Services, the North Denmark Region | Recruiting | Aalborg | 9000 | Denmark |
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.
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.
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.
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| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D058687 | Out-of-Hospital Cardiac Arrest |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Anterior-posterior pad positioning | Other | Defibrillation pads positioned anterior-posterior |
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| Double-sequential defibrillation | Other | Combination of anterior-lateral and anterior-posterior pad positioning for a total of 4 pads and 2 shocks. |
|
| 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). | 90 days after the cardiac arrest |
| Danish Air Ambulance, Danish Regions | Not yet recruiting | Aarhus N | 8200 | Denmark |
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| Prehospital Emergency Medical Services, Central Denmark Region | Recruiting | Aarhus N | 8200 | Denmark |
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| Copenhagen Emergency Medical Services, the Capital Region of Denmark | Not yet recruiting | Ballerup Municipality | 2750 | Denmark |
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| The Prehospital Center, Region Zealand | Not yet recruiting | Næstved | 4700 | Denmark |
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| Emergency Medical Services, the Region of Southern Denmark | Not yet recruiting | Vejle | 7100 | Denmark |
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