Stroke
Conditions
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).
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.
Interventions
DRUGRanitidine
50 mg single dose injection of Ranitidine
DRUGPlacebo
50 mg single dose injection of normal saline (placebo)
OTHERAdvanced notification
Advanced notification of study via faxed consent to local Emergency Room (ER)
OTHERNo advanced notification
No advanced notification of study via faxed consent to local Emergency Room (ER)
Sponsors
University of Iowa
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 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. | 15 |
| 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 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. | 15 |
| 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 Air Care to the outside hospital where the subject is at, and the subject is randomized to receiving Ranitidine. | 5 |
| 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 Air Care has arrived to the outside hospital where the subject is at, and the subject is randomized to receiving Ranitidine. | 7 |
| 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. | 7 |
| 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. | 3 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Enrollment Period (Intervention) | Death | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 |
| Enrollment Period (Intervention) | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
| Enrollment Period (Intervention) | Unknown if alive or deceased | 0 | 0 | 0 | 0 | 1 | 2 | 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) | Physician Decision | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
| Notification Period (Informed Consent) | Subject refused consent for AIRDOC | 21 | 21 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | No Advanced Notification + Consent +Not Eligible for Study Med | Advanced Notification + Ranitidine | No Advanced Notification + Ranitidine | Advanced Notification + Consent + Not Eligible for Study Med | Advanced Notification + Placebo | No Advanced Notification + Placebo | Total |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 3 Participants | 3 Participants | 9 Participants | 3 Participants | 2 Participants | 27 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 2 Participants | 4 Participants | 6 Participants | 4 Participants | 1 Participants | 25 Participants |
| Age Continuous | 62 years STANDARD_DEVIATION 16 | 67 years STANDARD_DEVIATION 13 | 62 years STANDARD_DEVIATION 12 | 66 years STANDARD_DEVIATION 14 | 62 years STANDARD_DEVIATION 8 | 68 years STANDARD_DEVIATION 12 | 64 years STANDARD_DEVIATION 13 |
| Region of Enrollment United States | 15 participants | 5 participants | 7 participants | 15 participants | 7 participants | 3 participants | 52 participants |
| Sex: Female, Male Female | 7 Participants | 3 Participants | 2 Participants | 8 Participants | 1 Participants | 2 Participants | 23 Participants |
| Sex: Female, Male Male | 8 Participants | 2 Participants | 5 Participants | 7 Participants | 6 Participants | 1 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 15 | 0 / 15 | 0 / 5 | 0 / 7 | 1 / 7 | 0 / 3 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 | 1 / 5 | 0 / 7 | 1 / 7 | 0 / 3 |
Outcome results
Primary
The Benefit of Advanced Notification in Promoting Informed Consent
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.
Population: Intention to treat analysis for primary outcome (number of patients consented).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Advanced Notification | The Benefit of Advanced Notification in Promoting Informed Consent | 27 Participants |
| No Advanced Notification | The Benefit of Advanced Notification in Promoting Informed Consent | 25 Participants |
Secondary
Prevention of Chemical Pneumonitis
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)
Population: Intention to treat analysis for secondary outcome (number of participants with aspiration pneumonia).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Advanced Notification | Prevention of Chemical Pneumonitis | 5 Participants |
| No Advanced Notification | Prevention of Chemical Pneumonitis | 7 Participants |
| Advanced Notification + Placebo | Prevention of Chemical Pneumonitis | 6 Participants |
| No Advanced Notification + Placebo | Prevention of Chemical Pneumonitis | 3 Participants |