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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Extending Acute Stroke Trials to the Aerial Inter-hospital Transfer Setting (AIRDOC)

Conditions
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Stroke

Intervention / Treatment
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* Drug: Ranitidine
* Drug: Placebo
* Other: Advanced notification
* Other: No advanced notification


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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