Public Access Defibrillation by Activated Citizen First-responders - The HeartRunner Trial
Phase: NA
Conditions: Out-Of-Hospital Cardiac Arrest
Sponsor: Emergency Medical Services, Capital Region, Denmark

 
 
December 3, 2020 
 
Protocol Changes 
Changes made from version 2 (published May 14, 2019) to version 3 (December 3, 2020) 
• 
Two new investigators added (title page):  
Mads Tofte Gregers, Copenhagen Emergency Medical Services, Ballerup, Denmark 
Annette Kjær Ersbøll, National Institute of Public Health, University of Southern Denmark, 
Copenhagen, Denmark 
One investigator removed (title page): 
Lena Karlsson, Copenhagen Emergency Medical Services, Ballerup, Denmark 
• Power calculation changed. Baseline survival is increased from 12% to 15% based on data 
from 2018 from the Danish Cardiac Arrest Registry that has been published recently. Effect 
estimate for stratum 1 has been decreased from 35% to 25%. The new power calculation, 
including these new data, results in a sample size of 536 patient for both stratum 1 and 2. 
Since we are expecting 64% to be true OHCA and a citizen responder only arriving before 
EMS in 40% of the cases, we will include 2094 patients in stratum 1 and 2094 patients in 
stratum 2 (section 5.2) 
• Length of study changed from 4 years to up to 8 years, and total included patients changed 
to approximately 4200 because of changes in power calculation (multiple sections) 
• New wording for the approval from the Ethics Committee and addition of add-on approvals 
from the Danish Patient Safety Authority for data collection in 2019 and 2020 (Scientific 
summary and section 8) 
• Secondary outcome. Neurological intact survival will be assessed at hospital discharge 
through patient’s charts, not at 30 days. This is changed in multiple sections and a new data 
source has been added to section 4.12 
• Safety outcome. Psychological impact will not be assessed at 4 weeks but assessed through 
a survey sent out 90 minutes after activation. Non-responders will be followed-up by phone 
call, text message or e-mail.  
• Stratum 3 will not be included in analyses since this stratum is assumed to be very small. 
• One subgroup has been deleted (arrival of citizen responders prior to EMS, since this is not 
assessable for the control group). The subgroup assessing OHCAs in public and residential 
settings has been divided op into two separate groups.  
• The wording heart runner has been changed to citizen responder throughout the protocol 

 
 
December 3, 2020 
 
• Corrections of grammar and minor typing errors throughout the protocol