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| Name | Class |
|---|---|
| TrygFonden, Denmark | INDUSTRY |
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The study will assess 30-day survival for cases where volunteer citizen responders ('heart runners') were activated through a smartphone app to retrieve an AED in case of suspected out-of-hospital cardiac arrest (OHCA) versus standard emergency medical services care. The study will randomize emergency medical dispatch center incoming calls which are suspected out-of-hospital cardiac arrest, such that half will be randomized to activation of heart runners and half to no activation of heart runners (standard care). The study will also assess physical or psychological risks involved for the activated heart runners.
Chances of survival after out-of-hospital cardiac arrest decrease 10% per minute from collapse until defibrillation. Activating volunteer citizens through the emergency medical dispatch center can potentially increase rates of bystander defibrillation and survival. The HeartRunner trial will investigage the effect of activating registered volunteer citizens through a mobile app integrated with the emergency medical services on 30-day survival following out-of-hospital cardiac arrest. Both arms will receive standard care by the Emergency Medical Services. The intervention arm will additionally receive the activation of volunteer citizen responders. The randomization will take place independently in 3 different strata according to heart runner distance to OHCA (< 3 min, 3-9 min, > 9 min). The trial will also assess whether it is safe, both physically and psychologically, to activate volunteer citizen responders to respond to out-of-hospital cardiac arrests.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care (control arm) | No Intervention | These cardiac arrests will receive standard EMS response. | |
| HeartRunner Activation | Experimental | For these cardiac arrests, HeartRunners will be activated in addition to standard EMS response. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Activation of HeartRunners | Other | Activation of volunteer citizen first-responders to respond to nearby cardiac arrests |
|
| Measure | Description | Time Frame |
|---|---|---|
| 30-day survival | Patient alive 30 days after date of out-of-hospital cardiac arrest | 30 days after date of out-of-hospital cardiac arrest |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of bystander defibrillation | Percentage of patients who received defibrillation prior to EMS arrival | During cardiac arrest |
| Rates of bystander cardiopulmonary resuscitation | Percentage of patients who received bystander cardiopulmonary resuscitation prior to EMS arrival |
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Inclusion Criteria:
Exclusion Criteria:
Emergency medical dispatchers are instructed not to activate heart runners in case any of the exclusion criteria above. However, since it can be challenging for emergency medical dispatchers to gather sufficient information about the patient within the first few minutes, heart runners will admittedly be activated even though they should not have been. Since randomization will occur for all cases in which a heart runner is activated, cases with any of the exclusion criteria will be secondarily excluded.
These cases will be accounted for but not included in analyses of outcome. Our pilot study showed approximately 60% of suspected cardiac arrests were true cardiac arrests. Therefore, we expect 40% of cases for which heart runners were dispatched not to be true cardiac arrests.
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| Name | Affiliation | Role |
|---|---|---|
| Fredrik Folke, MD, PhD | Copenhagen EMS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emergency Medical Services Copenhagen | Copenhagen | Ballerup | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35060395 | Derived | Mottlau KH, Andelius LC, Gregersen R, Malta Hansen C, Folke F. Citizen Responder Activation in Out-of-Hospital Cardiac Arrest by Time of Day and Day of Week. J Am Heart Assoc. 2022 Feb;11(3):e023413. doi: 10.1161/JAHA.121.023413. Epub 2022 Jan 21. | |
| 32616162 | Derived | Andelius L, Malta Hansen C, Lippert FK, Karlsson L, Torp-Pedersen C, Kjaer Ersboll A, Kober L, Collatz Christensen H, Blomberg SN, Gislason GH, Folke F. Smartphone Activation of Citizen Responders to Facilitate Defibrillation in Out-of-Hospital Cardiac Arrest. J Am Coll Cardiol. 2020 Jul 7;76(1):43-53. doi: 10.1016/j.jacc.2020.04.073. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: Changes to protocol | Dec 3, 2020 | Dec 4, 2020 | Prot_004.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Updated protocol | Dec 3, 2020 | Dec 4, 2020 | Prot_SAP_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Detailed Final Statistical Analysis Plan | Dec 3, 2020 | Dec 4, 2020 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D058687 | Out-of-Hospital Cardiac Arrest |
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| During cardiac arrest |
| Rates of return of spontaneuous circulation | sustained circulation indicating successful resuscitation | Immediately after out-of-hospital cardiac arrest |
| Rates of survival after 1 year | percentage of patients alive 1 year after out-of-hospital cardiac arrest | 1 year after date of out-of-hospital cardiac arrest |
| Rates of neurological intact survival | percentage of patients with cerebral performance category score of 1-2 | At hospital discharge |