Extending Acute Stroke Trials to the Aerial Inter-Hospital Transfer Setting
Information source: University of Iowa
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Stroke
Intervention: Ranitidine (Drug); Placebo (Drug); Advanced notification (Other); No advanced notification (Other)
Phase: N/A
Status: Completed
Sponsored by: University of Iowa Official(s) and/or principal investigator(s):
Enrique C Leira, MD, Principal Investigator, Affiliation: University of Iowa
Summary
We are inviting patients who have been diagnosed with an ischemic or hemorrhagic stroke and
are being transferred by helicopter 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 mg) or placebo (normal saline).
Clinical Details
Official title: Extending Acute Stroke Trials to the Aerial Inter-Hospital Transfer Setting
Study design: Other, Randomized, Double Blind (Subject, Investigator), Placebo Control, Factorial Assignment
Primary outcome: Feasibility of conducting research in aerial setting
Secondary outcome: Prevention of chemical pneumonitis
Detailed description:
Ischemic or hemorrhagic stroke patients transferred by helicopter 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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 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.
- 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.
Locations and Contacts
University of Iowa, Iowa City, Iowa 52242, United States
Additional Information
Starting date: January 2007
Ending date: January 2008
Last updated: February 20, 2008
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