Quality and Effectiveness of Thrombolytic Care During Inter-hospital Transfer ("Drip-Ship") With Air Ambulance Services
Conditions: Stroke
Sponsor: University of Iowa

Thrombolytic Care During Inter-Hospital Transfer 
 
NCT: 02752256 
 
9/11/2015 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study Protocol  
 
Inclusion Criteria  
 
Transfer population: Include all patients transferred to UIHC via air ambulance 
after receiving rtPA for acute ischemic stroke.  
 
Control population: All patients presenting directly to comprehensive stroke 
center (UIHC) and receive rtPA for acute ischemic stroke.  
 
Exclusion Criteria  
Prisoners, non-english speaking and pregnant patients, patients unable to 
consent for us to collect the data or do not have a family member who is able to 
consent.  
 
Enrollment and Consent process  
 
1) Patients will be identified when the principal investigator (PI) receives a page 
that a code stroke patient who received rtPA has arrived or for the control 
population, the patient receives rtPA in the comprehensive stroke center 
Emergency Department.  
2) Within 24 hours of the patient's arrival, the patient and/or legally authorized 
representative will be approached by the PI for consent to access their medical 
record.  
3) The PI will discuss the study, including the risks and benefits with the patient 
and/or legally authorized representative  
4) The patient/legal authorized representative will be informed that the decision 
whether to participate will not affect the clinical care he/she (the person he/she is 
representing) receives.  
5) Once all of the questions have been answered, the informed consent will be 
handed to the patient and/or legally authorized representative to review.  
6) They will have up to 24 hours to decide if they would like to take part in the 
study.  
7) Consent will be shown by the signing of the consent document.  
8) After consent is obtained, the PI will begin to collect the patient's data needed 
for the study and the survey data will be linked to the actual patient.  
 
Data Collection Includes:  
Age, date of birth, height, weight, sex, transferring hospital, onset of symptoms, 
initial NIHSS, initial heart rate/systolic blood pressure, time to rtPA 
administration, rtPA dose, stroke protocol adherence, time to flight, flight time, 
medications administered in flight, National Institutes of Health Stroke Scale 
(NIHSS) in flight, time rtPA infusing in flight, comprehensive stroke center ED 
arrival time, time rtPA completed, comprehensive stroke center NIHSS, 
medications administered in comprehensive stroke center ED, intubation, 
adverse events, time to admission, Operating room intervention, stroke protocol 

adherence, 24 hour follow-up CT, Intensive Care Unit and hospital length of stay, 
discharge disposition and NIHSS, in-hospital mortality, 90-day Modified Rankin 
Scale.  
 
Statistical Analysis Plan  
The primary outcome was percentage of participants with an rtPA protocol 
violation, with secondary outcomes of time to rtPA administration and in-hospital 
mortality. We characterized each outcome through descriptive statistics (mean, 
median, and interquartile range) for each treatment arm. Differences between 
each group were evaluated using t-tests for continuous measurements and chi-
squared tests for categorical variables with exact p- values. Our hypothesis was 
that inter-hospital transfer results in significantly more rtPA protocol violations 
compared to presenting directly to a comprehensive stroke center. All analyses 
were completed using SAS software, version 9.3 of the SAS System for Microsoft 
(SAS Institute Inc, Cary, NC).