N/A
Completed N=100
Extending Acute Stroke Trials to the Aerial Inter-hospital Transfer Setting
Source: ClinicalTrials.gov NCT00585351 ↗Enrolled (actual)
100
Serious AEs
3.9%
Results posted
Jan 2013
Primary outcomePrimary: The Benefit of Advanced Notification in Promoting Informed Consent — 27; 25 Participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Benefit of Advanced Notification in Promoting Informed Consent |
27; 25 | — |
| SECONDARY Prevention of Chemical Pneumonitis |
5; 7; 6; 3 | — |
Eligibility 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 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 10K.
- Hemoglobin 300 mg/dl.
- Current need for antibiotics.
- Terminal illness with expected survival < 3 months.
- Prison inmate or institutionalized individual.
Data sourced from ClinicalTrials.gov (NCT00585351). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.