Clinical trial NCT03835403: The HeartRunner Trial
Official title: Public Access Defibrillation by Activated Citizen First-responders - The HeartRunner Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Out-Of-Hospital Cardiac Arrest
Lead sponsor: Emergency Medical Services, Capital Region, Denmark
Sponsor class: OTHER_GOV
Collaborators: name: TrygFonden, Denmark
First posted: 2019-02-08
Enrollment: 1600
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* All out-of-hospital cardiac arrests recognized by Emergency Medical Dispatcher and where the HeartRunner system is activated.
* Non-traumatic etiology, this excludes intoxication, drowning or suicide.
* Age \> 7 years

Exclusion Criteria:

* Caller is not in direct contact with the patient
* If Emergency Medical Dispatcher deems AED is not indicated, e.g., in nursing homes where trained personal is present.
* OHCAs not treated by the EMS due to ethical reasons or obvious signs of death
* OHCAs with no heart runners within 1800 meters
* Not true cardiac arrest (suspected, but not verified)
* EMS-witnessed OHCAs

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.

Primary outcomes:
measure: 30-day survival
timeFrame: 30 days after date of out-of-hospital cardiac arrest
Secondary outcomes:
measure: Rates of bystander defibrillation
timeFrame: During cardiac arrest
measure: Rates of bystander cardiopulmonary resuscitation
timeFrame: During cardiac arrest
measure: Rates of return of spontaneuous circulation
timeFrame: Immediately after out-of-hospital cardiac arrest
measure: Rates of survival after 1 year
timeFrame: 1 year after date of out-of-hospital cardiac arrest
measure: Rates of neurological intact survival
timeFrame: At hospital discharge
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Emergency Medical Services Copenhagen
state: Ballerup
Study officials:
affiliation: Copenhagen EMS
name: Fredrik Folke, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.