Trial Outcomes & Findings for Extending Acute Stroke Trials to the Aerial Inter-hospital Transfer Setting (NCT NCT00585351)
NCT ID: NCT00585351
Last Updated: 2013-01-16
Results Overview
Number of subjects that provided informed consent for study (advanced notification vs. no advanced notification).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
Assessed at time of enrollment into the study.
Results posted on
2013-01-16
Participant Flow
The recruitment period for this study was from January 2007 to January 2008. Subjects recruited for this study were patients with presumed ischemic stroke or intracranial hemorrhage that were transferred to the University of Iowa Hospitals and Clinics via Air Care helicopter transport.
Participant milestones
| Measure |
Advanced Notification
Subjects in this group are randomized to receiving advanced notification about the AIRDOC study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care helicopter crew to the outside hospital where the subject is at.
|
No Advanced Notification
Subjects in this group are randomized to not receiving any advanced notification about the study, so they are not provided the informed consent document until Air Care helicopter crew has arrived to the outside hospital where the subject is at.
|
Advanced Notification + Consent + Not Eligible for Study Med
Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of the Air Care helicopter crew to the outside hospital where the subject is at. Consent is obtained by Air Care, however, after assessments and review of records, the subject is deemed not eligible to be randomized to receive study medication.
|
No Advanced Notification + Consent +Not Eligible for Study Med
Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until the Air Care helicopter crew has arrived to the outside hospital where the subject is at. Consent is obtained by Air Care, however, after assessments and review of records, the subject is deemed not eligible to be randomized to receive study medication.
|
Advanced Notification + Ranitidine
Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of the Air Care helicopter crew to the outside hospital where the subject is at, and the subject is randomized to receiving Ranitidine.
|
No Advanced Notification + Ranitidine
Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until the Air Care helicopter crew has arrived to the outside hospital where the subject is at, and the subject is randomized to receiving Ranitidine.
|
Advanced Notification + Placebo
Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of the Air Care helicopter crew to the outside hospital where the subject is at, and the subject is randomized to receiving placebo.
|
No Advanced Notification + Placebo
Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until the Air Care helicopter crew has arrived to the outside hospital where the subject is at, and the subject is randomized to receiving placebo.
|
|---|---|---|---|---|---|---|---|---|
|
Notification Period (Informed Consent)
STARTED
|
50
|
50
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Notification Period (Informed Consent)
COMPLETED
|
27
|
25
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Notification Period (Informed Consent)
NOT COMPLETED
|
23
|
25
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Enrollment Period (Intervention)
STARTED
|
0
|
0
|
15
|
15
|
5
|
7
|
7
|
3
|
|
Enrollment Period (Intervention)
COMPLETED
|
0
|
0
|
15
|
15
|
3
|
5
|
5
|
2
|
|
Enrollment Period (Intervention)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
2
|
2
|
2
|
1
|
Reasons for withdrawal
| Measure |
Advanced Notification
Subjects in this group are randomized to receiving advanced notification about the AIRDOC study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care helicopter crew to the outside hospital where the subject is at.
|
No Advanced Notification
Subjects in this group are randomized to not receiving any advanced notification about the study, so they are not provided the informed consent document until Air Care helicopter crew has arrived to the outside hospital where the subject is at.
|
Advanced Notification + Consent + Not Eligible for Study Med
Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of the Air Care helicopter crew to the outside hospital where the subject is at. Consent is obtained by Air Care, however, after assessments and review of records, the subject is deemed not eligible to be randomized to receive study medication.
|
No Advanced Notification + Consent +Not Eligible for Study Med
Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until the Air Care helicopter crew has arrived to the outside hospital where the subject is at. Consent is obtained by Air Care, however, after assessments and review of records, the subject is deemed not eligible to be randomized to receive study medication.
|
Advanced Notification + Ranitidine
Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of the Air Care helicopter crew to the outside hospital where the subject is at, and the subject is randomized to receiving Ranitidine.
|
No Advanced Notification + Ranitidine
Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until the Air Care helicopter crew has arrived to the outside hospital where the subject is at, and the subject is randomized to receiving Ranitidine.
|
Advanced Notification + Placebo
Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of the Air Care helicopter crew to the outside hospital where the subject is at, and the subject is randomized to receiving placebo.
|
No Advanced Notification + Placebo
Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until the Air Care helicopter crew has arrived to the outside hospital where the subject is at, and the subject is randomized to receiving placebo.
|
|---|---|---|---|---|---|---|---|---|
|
Notification Period (Informed Consent)
Physician Decision
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Notification Period (Informed Consent)
Flight aborted
|
2
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Notification Period (Informed Consent)
No study medication on flight
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Notification Period (Informed Consent)
Subject refused consent for AIRDOC
|
21
|
21
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Enrollment Period (Intervention)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Enrollment Period (Intervention)
Death
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
|
Enrollment Period (Intervention)
Unknown if alive or deceased
|
0
|
0
|
0
|
0
|
1
|
2
|
0
|
0
|
Baseline Characteristics
Extending Acute Stroke Trials to the Aerial Inter-hospital Transfer Setting
Baseline characteristics by cohort
| Measure |
Advanced Notification + Consent + Not Eligible for Study Med
n=15 Participants
Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care to the outside hospital where the subject is at. Consent is obtained by Air Care, however, after assessments and review of records, the subject is deemed not eligible to be randomized to receive study medication.
|
No Advanced Notification + Consent +Not Eligible for Study Med
n=15 Participants
Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until Air Care has arrived to the outside hospital where the subject is at. Consent is obtained by Air Care, however, after assessments and review of records, the subject is deemed not eligible to be randomized to receive study medication.
|
Advanced Notification + Ranitidine
n=5 Participants
Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care to the outside hospital where the subject is at, and the subject is randomized to receiving Ranitidine.
|
No Advanced Notification + Ranitidine
n=7 Participants
Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until Air Care has arrived to the outside hospital where the subject is at, and the subject is randomized to receiving Ranitidine.
|
Advanced Notification + Placebo
n=7 Participants
Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care to the outside hospital where the subject is at, and the subject is randomized to receiving placebo.
|
No Advanced Notification + Placebo
n=3 Participants
Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until Air Care has arrived to the outside hospital where the subject is at, and the subject is randomized to receiving placebo.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
25 Participants
n=115 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
27 Participants
n=115 Participants
|
|
Age Continuous
|
66 years
STANDARD_DEVIATION 14 • n=5 Participants
|
62 years
STANDARD_DEVIATION 16 • n=7 Participants
|
67 years
STANDARD_DEVIATION 13 • n=5 Participants
|
62 years
STANDARD_DEVIATION 12 • n=4 Participants
|
62 years
STANDARD_DEVIATION 8 • n=21 Participants
|
68 years
STANDARD_DEVIATION 12 • n=10 Participants
|
64 years
STANDARD_DEVIATION 13 • n=115 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
23 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
29 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
5 participants
n=5 Participants
|
7 participants
n=4 Participants
|
7 participants
n=21 Participants
|
3 participants
n=10 Participants
|
52 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Assessed at time of enrollment into the study.Population: Intention to treat analysis for primary outcome (number of patients consented).
Number of subjects that provided informed consent for study (advanced notification vs. no advanced notification).
Outcome measures
| Measure |
Advanced Notification
n=50 Participants
Subjects in this group are randomized to receiving advanced notification about the AIRDOC study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care helicopter crew to the outside hospital where the subject is at.
|
No Advanced Notification
n=50 Participants
Subjects in this group are randomized to not receiving any advanced notification about the study, so they are not provided the informed consent document until Air Care helicopter crew has arrived to the outside hospital where the subject is at.
|
Advanced Notification + Placebo
Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care to the outside hospital where the subject is at, and the subject is randomized to receiving placebo.
|
No Advanced Notification + Placebo
Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until Air Care has arrived to the outside hospital where the subject is at, and the subject is randomized to receiving placebo.
|
|---|---|---|---|---|
|
The Benefit of Advanced Notification in Promoting Informed Consent
|
27 Participants
|
25 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Assessed on the day of discharge (average length of stay is approximately 3-7 days)Population: Intention to treat analysis for secondary outcome (number of participants with aspiration pneumonia).
Number of subjects that did not develop aspiration pneumonia in the intervention group (Ranitidine vs. placebo).
Outcome measures
| Measure |
Advanced Notification
n=5 Participants
Subjects in this group are randomized to receiving advanced notification about the AIRDOC study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care helicopter crew to the outside hospital where the subject is at.
|
No Advanced Notification
n=7 Participants
Subjects in this group are randomized to not receiving any advanced notification about the study, so they are not provided the informed consent document until Air Care helicopter crew has arrived to the outside hospital where the subject is at.
|
Advanced Notification + Placebo
n=7 Participants
Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care to the outside hospital where the subject is at, and the subject is randomized to receiving placebo.
|
No Advanced Notification + Placebo
n=3 Participants
Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until Air Care has arrived to the outside hospital where the subject is at, and the subject is randomized to receiving placebo.
|
|---|---|---|---|---|
|
Prevention of Chemical Pneumonitis
|
5 Participants
|
7 Participants
|
6 Participants
|
3 Participants
|
Adverse Events
No Advanced Notification + Ranitidine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Advanced Notification + Placebo
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
No Advanced Notification + Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Advanced Notification + Consent + Not Eligible for Study Med
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Advanced Notification + Consent +Not Eligible for Study Med
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Advanced Notification + Ranitidine
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
No Advanced Notification + Ranitidine
n=7 participants at risk
Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until Air Care has arrived to the outside hospital where the subject is at, and the subject is randomized to receiving Ranitidine.
|
Advanced Notification + Placebo
n=7 participants at risk
Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care to the outside hospital where the subject is at, and the subject is randomized to receiving placebo.
|
No Advanced Notification + Placebo
n=3 participants at risk
Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until Air Care has arrived to the outside hospital where the subject is at, and the subject is randomized to receiving placebo.
|
Advanced Notification + Consent + Not Eligible for Study Med
n=15 participants at risk
Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care to the outside hospital where the subject is at. Consent is obtained by Air Care, however, after assessments and review of records, the subject is deemed not eligible to be randomized to receive study medication.
|
No Advanced Notification + Consent +Not Eligible for Study Med
n=15 participants at risk
Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until Air Care has arrived to the outside hospital where the subject is at. Consent is obtained by Air Care, however, after assessments and review of records, the subject is deemed not eligible to be randomized to receive study medication.
|
Advanced Notification + Ranitidine
n=5 participants at risk
Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care to the outside hospital where the subject is at, and the subject is randomized to receiving Ranitidine.
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Subarachnoid Hemorrhage (SAH) resulting in Death
|
0.00%
0/7 • Adverse Events were reported to the investigator within 24 hours of acknowledgment. Serious Adverse Events were reported to the IRB within 24-72 hours.
AE not collected for X groups.
|
0.00%
0/7 • Adverse Events were reported to the investigator within 24 hours of acknowledgment. Serious Adverse Events were reported to the IRB within 24-72 hours.
AE not collected for X groups.
|
0.00%
0/3 • Adverse Events were reported to the investigator within 24 hours of acknowledgment. Serious Adverse Events were reported to the IRB within 24-72 hours.
AE not collected for X groups.
|
0.00%
0/15 • Adverse Events were reported to the investigator within 24 hours of acknowledgment. Serious Adverse Events were reported to the IRB within 24-72 hours.
AE not collected for X groups.
|
0.00%
0/15 • Adverse Events were reported to the investigator within 24 hours of acknowledgment. Serious Adverse Events were reported to the IRB within 24-72 hours.
AE not collected for X groups.
|
20.0%
1/5 • Number of events 1 • Adverse Events were reported to the investigator within 24 hours of acknowledgment. Serious Adverse Events were reported to the IRB within 24-72 hours.
AE not collected for X groups.
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/7 • Adverse Events were reported to the investigator within 24 hours of acknowledgment. Serious Adverse Events were reported to the IRB within 24-72 hours.
AE not collected for X groups.
|
14.3%
1/7 • Number of events 1 • Adverse Events were reported to the investigator within 24 hours of acknowledgment. Serious Adverse Events were reported to the IRB within 24-72 hours.
AE not collected for X groups.
|
0.00%
0/3 • Adverse Events were reported to the investigator within 24 hours of acknowledgment. Serious Adverse Events were reported to the IRB within 24-72 hours.
AE not collected for X groups.
|
0.00%
0/15 • Adverse Events were reported to the investigator within 24 hours of acknowledgment. Serious Adverse Events were reported to the IRB within 24-72 hours.
AE not collected for X groups.
|
0.00%
0/15 • Adverse Events were reported to the investigator within 24 hours of acknowledgment. Serious Adverse Events were reported to the IRB within 24-72 hours.
AE not collected for X groups.
|
0.00%
0/5 • Adverse Events were reported to the investigator within 24 hours of acknowledgment. Serious Adverse Events were reported to the IRB within 24-72 hours.
AE not collected for X groups.
|
Other adverse events
| Measure |
No Advanced Notification + Ranitidine
n=7 participants at risk
Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until Air Care has arrived to the outside hospital where the subject is at, and the subject is randomized to receiving Ranitidine.
|
Advanced Notification + Placebo
n=7 participants at risk
Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care to the outside hospital where the subject is at, and the subject is randomized to receiving placebo.
|
No Advanced Notification + Placebo
n=3 participants at risk
Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until Air Care has arrived to the outside hospital where the subject is at, and the subject is randomized to receiving placebo.
|
Advanced Notification + Consent + Not Eligible for Study Med
n=15 participants at risk
Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care to the outside hospital where the subject is at. Consent is obtained by Air Care, however, after assessments and review of records, the subject is deemed not eligible to be randomized to receive study medication.
|
No Advanced Notification + Consent +Not Eligible for Study Med
n=15 participants at risk
Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until Air Care has arrived to the outside hospital where the subject is at. Consent is obtained by Air Care, however, after assessments and review of records, the subject is deemed not eligible to be randomized to receive study medication.
|
Advanced Notification + Ranitidine
n=5 participants at risk
Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care to the outside hospital where the subject is at, and the subject is randomized to receiving Ranitidine.
|
|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Aspiration Pneumonia
|
0.00%
0/7 • Adverse Events were reported to the investigator within 24 hours of acknowledgment. Serious Adverse Events were reported to the IRB within 24-72 hours.
AE not collected for X groups.
|
14.3%
1/7 • Number of events 1 • Adverse Events were reported to the investigator within 24 hours of acknowledgment. Serious Adverse Events were reported to the IRB within 24-72 hours.
AE not collected for X groups.
|
0.00%
0/3 • Adverse Events were reported to the investigator within 24 hours of acknowledgment. Serious Adverse Events were reported to the IRB within 24-72 hours.
AE not collected for X groups.
|
0.00%
0/15 • Adverse Events were reported to the investigator within 24 hours of acknowledgment. Serious Adverse Events were reported to the IRB within 24-72 hours.
AE not collected for X groups.
|
0.00%
0/15 • Adverse Events were reported to the investigator within 24 hours of acknowledgment. Serious Adverse Events were reported to the IRB within 24-72 hours.
AE not collected for X groups.
|
0.00%
0/5 • Adverse Events were reported to the investigator within 24 hours of acknowledgment. Serious Adverse Events were reported to the IRB within 24-72 hours.
AE not collected for X groups.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place