AIRDOC: Extending Acute Stroke Trials to the Aerial Inter-hospital Transfer Setting

• Sponsor: University of Iowa (Other)
• Overall Status: Completed
• CT.gov ID: NCT00585351
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 4
• Duration (Months): 12
• Patients Per Site Per Month: 8.3

Study Details

Study Description

Brief Summary

We are inviting patients who have been diagnosed with an ischemic or hemorrhagic stroke and are being transferred by Air Care helicopters to the University of Iowa Hospitals and Clinics (UIHC) for further care to participate in this research study to test the following: 1) To test whether it is possible to go through all the procedures necessary to start a study, including an informed consent, before the patient is transferred by helicopter to Iowa City. 2)To test a low risk medication called, Ranitidine, that might lower the chances of developing chemical pneumonitis (irritation of the lungs by stomach contents), a fairly common complication in patients that have had a stroke. Patients will be randomly assigned to receive a single dose injection of either Ranitidine (50 milligrams (mg)) or placebo (normal saline).

Condition or Disease	Intervention/Treatment	Phase
Stroke	Drug: Ranitidine; Drug: Placebo; Other: Advanced notification; Other: No advanced notification	N/A

Detailed Description

Ischemic or hemorrhagic stroke patients transferred by Air Care helicopters to the University of Iowa Hospitals and Clinics (UIHC) for further care will be invited to participate in a research study testing the following: 1) feasibility of beginning a research study while the patient is in transit to UIHC, and 2)test efficacy of a low risk medication called, Ranitidine, to help lower the chances of developing chemical pneumonitis in patients that have had a stroke.

Patients will be randomly assigned to receive a single dose injection of either Ranitidine (50 mg) or placebo (normal saline). Independently of the study injection, the patient will continue to receive the usual standard medical care for their stroke. The patient will be cared for by a team of doctors in the stroke service. Some of these doctors and nurses are investigators for this study and will assess the patient's neurological status to see how much the stroke has affected the patient. They will also determine by the patient's symptoms and the results of a chest x-ray (if that test becomes necessary due to fever) whether the patient has developed chemical pneumonitis They will also administer a questionnaire to the patient or their relative prior to discharge about their thoughts on doing clinical studies while being transported by the helicopter and to collect any thoughts they may have had about improving this process. Completing the questionnaire is voluntary, and the patient is free to skip any question that they would prefer to not answer.

Three months after the patient has had the stroke, they or their relative will be contacted by phone to determine the patient's long-term outcome after their stroke. After the follow-up telephone conversation the participation in the study will end.

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Double (Participant, Investigator)
• Official Title: Extending Acute Stroke Trials to the Aerial Inter-hospital Transfer Setting (AIRDOC)
• Study Start Date: Jan 1, 2007
• Actual Primary Completion Date: Jan 1, 2008
• Actual Study Completion Date: Jan 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: I Advanced Notification + Ranitidine	Drug: Ranitidine; 50 mg single dose injection of Ranitidine; Other: Advanced notification; Advanced notification of study via faxed consent to local Emergency Room (ER)
Active Comparator: II Advanced Notification + Placebo	Drug: Placebo; 50 mg single dose injection of normal saline (placebo); Other: Advanced notification; Advanced notification of study via faxed consent to local Emergency Room (ER)
Active Comparator: III No advanced notification + Ranitidine	Drug: Ranitidine; 50 mg single dose injection of Ranitidine; Other: No advanced notification; No advanced notification of study via faxed consent to local Emergency Room (ER)
Placebo Comparator: IV No advanced notification + Placebo	Drug: Placebo; 50 mg single dose injection of normal saline (placebo); Other: No advanced notification; No advanced notification of study via faxed consent to local Emergency Room (ER)

Outcome Measures

Primary Outcome Measures

1. The Benefit of Advanced Notification in Promoting Informed Consent [Assessed at time of enrollment into the study.]

   Number of subjects that provided informed consent for study (advanced notification vs. no advanced notification).

Secondary Outcome Measures

1. Prevention of Chemical Pneumonitis [Assessed on the day of discharge (average length of stay is approximately 3-7 days)]

   Number of subjects that did not develop aspiration pneumonia in the intervention group (Ranitidine vs. placebo).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age 18 years or older.

• Presumed Ischemic stroke or intracerebral hemorrhage within past 12 hours.

• NIH Stroke Scale (NIHSS) score >/=1 point.

• Negative pregnancy test (females < 50 years old).

• No pre-stroke disability (Rankin Scale Score 0-1).

• Patient evaluated for intravenous recombinant tissue Plasminogen Activator (rtPA) and intubation by the local physicians (if appropriate).

Exclusion Criteria:

• Onset of symptoms > 12 hours or uncertain time of origin (if patient awakens with stroke, the time of onset will be the last time patient was normal).

• Reason for the transfer is to receive rtPA at the University of Iowa.

• Non-stroke etiology for symptoms.

• Temperature > 37.8 C.

• Systolic blood pressure < 100 mm Hg.

• Known allergy to ranitidine.

• White Blood Cell (WBC) > 10K.

• Hemoglobin < 9.0.

• Platelets < 100,000.

• Glucose < 60 or > 300 mg/dl.

• Current need for antibiotics.

• Terminal illness with expected survival < 3 months.

• Prison inmate or institutionalized individual.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Iowa	Iowa City	Iowa	United States	52242

Sponsors and Collaborators

• University of Iowa

Investigators

• Principal Investigator: Enrique C Leira, MD, University of Iowa

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Iowa
• ClinicalTrials.gov Identifier: NCT00585351
• Other Study ID Numbers: NIH 5K12RR017700-04; NIH 5K12RR017700-04
• First Posted: Jan 3, 2008
• Last Update Posted: Jan 16, 2013
• Last Verified: Jan 1, 2013

• Additional relevant MeSH terms: Stroke; Ranitidine; Ranitidine bismuth citrate

Study Results

Participant Flow

Recruitment Details	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.

Arm/Group Title	Advanced Notification	No Advanced Notification	Advanced Notification + Consent + Not Eligible for Study Med	No Advanced Notification + Consent +Not Eligible for Study Med	Advanced Notification + Ranitidine	No Advanced Notification + Ranitidine	Advanced Notification + Placebo	No Advanced Notification + Placebo
Arm/Group Description	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.	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.	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.	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.	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.	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.	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.	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.
Period Title: Notification Period (Informed Consent)
STARTED	50	50	0	0	0	0	0	0
COMPLETED	27	25	0	0	0	0	0	0
NOT COMPLETED	23	25	0	0	0	0	0	0
Period Title: Notification Period (Informed Consent)
STARTED	0	0	15	15	5	7	7	3
COMPLETED	0	0	15	15	3	5	5	2
NOT COMPLETED	0	0	0	0	2	2	2	1

Baseline Characteristics

Arm/Group Title	Advanced Notification + Consent + Not Eligible for Study Med	No Advanced Notification + Consent +Not Eligible for Study Med	Advanced Notification + Ranitidine	No Advanced Notification + Ranitidine	Advanced Notification + Placebo	No Advanced Notification + Placebo	Total
Arm/Group Description	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.	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.	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.	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.	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.	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 of all reporting groups
Overall Participants	15	15	5	7	7	3	52
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	6 40%	8 53.3%	2 40%	4 57.1%	4 57.1%	1 33.3%	25 48.1%
>=65 years	9 60%	7 46.7%	3 60%	3 42.9%	3 42.9%	2 66.7%	27 51.9%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66 (14)	62 (16)	67 (13)	62 (12)	62 (8)	68 (12)	64 (13)
Sex: Female, Male (Count of Participants)
Female	8 53.3%	7 46.7%	3 60%	2 28.6%	1 14.3%	2 66.7%	23 44.2%
Male	7 46.7%	8 53.3%	2 40%	5 71.4%	6 85.7%	1 33.3%	29 55.8%
Region of Enrollment (participants) [Number]
United States	15 100%	15 100%	5 100%	7 100%	7 100%	3 100%	52 100%

Outcome Measures

1. Primary Outcome

Title	The Benefit of Advanced Notification in Promoting Informed Consent
Description	Number of subjects that provided informed consent for study (advanced notification vs. no advanced notification).
Time Frame	Assessed at time of enrollment into the study.

Outcome Measure Data

Analysis Population Description

Intention to treat analysis for primary outcome (number of patients consented).

Arm/Group Title	Advanced Notification	No Advanced Notification
Arm/Group Description	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.	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.
Measure Participants	50	50
Number [Participants]	27 180%	25 166.7%

2. Secondary Outcome

Title	Prevention of Chemical Pneumonitis
Description	Number of subjects that did not develop aspiration pneumonia in the intervention group (Ranitidine vs. placebo).
Time Frame	Assessed on the day of discharge (average length of stay is approximately 3-7 days)

Outcome Measure Data

Analysis Population Description

Intention to treat analysis for secondary outcome (number of participants with aspiration pneumonia).

Arm/Group Title	Advanced Notification + Ranitidine	No Advanced Notification + Ranitidine	Advanced Notification + Placebo	No Advanced Notification + Placebo
Arm/Group Description	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.	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.	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.	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.
Measure Participants	5	7	7	3
Number [Participants]	5 33.3%	7 46.7%	6 120%	3 42.9%

Adverse Events

Time Frame	Adverse Events were reported to the investigator within 24 hours of acknowledgment. Serious Adverse Events were reported to the IRB within 24-72 hours.
Adverse Event Reporting Description	AE not collected for X groups.
Arm/Group Title	Advanced Notification + Consent + Not Eligible for Study Med		No Advanced Notification + Consent +Not Eligible for Study Med		Advanced Notification + Ranitidine		No Advanced Notification + Ranitidine		Advanced Notification + Placebo		No Advanced Notification + Placebo
Arm/Group Description	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.		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.		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.		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.		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.		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.
All Cause Mortality
	Advanced Notification + Consent + Not Eligible for Study Med		No Advanced Notification + Consent +Not Eligible for Study Med		Advanced Notification + Ranitidine		No Advanced Notification + Ranitidine		Advanced Notification + Placebo		No Advanced Notification + Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Advanced Notification + Consent + Not Eligible for Study Med		No Advanced Notification + Consent +Not Eligible for Study Med		Advanced Notification + Ranitidine		No Advanced Notification + Ranitidine		Advanced Notification + Placebo		No Advanced Notification + Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)		1/5 (20%)		0/7 (0%)		1/7 (14.3%)		0/3 (0%)
Cardiac disorders
Cardiac Arrest	0/15 (0%)	0	0/15 (0%)	0	0/5 (0%)	0	0/7 (0%)	0	1/7 (14.3%)	1	0/3 (0%)	0
Nervous system disorders
Subarachnoid Hemorrhage (SAH) resulting in Death	0/15 (0%)	0	0/15 (0%)	0	1/5 (20%)	1	0/7 (0%)	0	0/7 (0%)	0	0/3 (0%)	0
Other (Not Including Serious) Adverse Events
	Advanced Notification + Consent + Not Eligible for Study Med		No Advanced Notification + Consent +Not Eligible for Study Med		Advanced Notification + Ranitidine		No Advanced Notification + Ranitidine		Advanced Notification + Placebo		No Advanced Notification + Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)		0/5 (0%)		0/7 (0%)		1/7 (14.3%)		0/3 (0%)
Respiratory, thoracic and mediastinal disorders
Aspiration Pneumonia	0/15 (0%)	0	0/15 (0%)	0	0/5 (0%)	0	0/7 (0%)	0	1/7 (14.3%)	1	0/3 (0%)	0

Limitations/Caveats

Some procedural errors by the helicopter crew at the start of the trial, reliability of the stroke diagnosis from the outside hospital, and the possibility for a lower consent rate if a higher risk profile medication were used instead of Ranitidine.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.